I

The fourth final provision of Law 10/2013 of 24 July, incorporating into Spanish law the Directives 2010 /84/EU of the European Parliament and of the Council of 15 December 2010 on the pharmacovigilance, and 2011 /62/EU of the European Parliament and of the Council of 8 June 2011 on the prevention of the entry of counterfeit medicinal products into the legal supply chain, and amending Law 29/2006 of 26 July on guarantees and use the rational use of medicines and medical devices, authorizes the Government to produce a recast text of the Law of guarantees and rational use of medicinal products and medical devices. This authorization, for a period of two years from the entry into force of the enabling legal text, is intended to consolidate, in a single text, the successive amendments which have been incorporated, since its entry into force, in that law. It includes the power to regularise, clarify and harmonise legal texts to be recast.

The authorization that gives coverage to this recast text has its reason to be in the need to give greater legal certainty to a regulation that has been characterized by a continuous succession of norms that have completed or modified, in a very disparate manner, the original text of Law 29/2006 of 26 July, which advises the adoption of a single text containing, duly harmonised, all applicable provisions in the field of this law. The resulting text should thus have a vocation for stability, once the necessary consolidation and adaptation processes have been successfully completed in order to ensure the continuity of the public and improved public health provision. the mechanisms of pharmacovigilance and the protection of the supply chain.

Law 29/2006 of 26 July, as well as Law 25/1990 of 20 December 1990, of the Medicamento, repealed by it, provided the Spanish company with an institutional instrument that would allow the problems relating to the drugs were addressed by how many social agents were involved in their management, in the perspective of the improvement of health care. The time since the adoption of the two legal texts makes it possible to state that the intended purpose of the pharmaceutical provision has been largely achieved as a universal service.

The pharmaceutical supply includes medicines and medical devices, as well as the set of actions aimed at ensuring that patients receive and use them in an appropriate manner for their clinical needs and in the precise doses according to their individual requirements, during the appropriate period of time, with the information necessary for their correct use and at the lowest possible cost.

It is necessary to make a positive assessment of what they are and what drugs and medical devices represent for the National Health System, so the pharmaceutical policy developed in recent decades has oriented in the direction of ensuring its availability to meet the needs of patients.

In this respect, the role of professionals in the sector has been instrumental in achieving these achievements. The physician is a central figure in the strategies of boosting quality in the pharmaceutical supply given the role attributed to it in the care of the patient's health and, therefore, in the prevention and diagnosis of the disease, thus as in the prescription, if any, of treatment with medicinal products. The work that pharmacists and other healthcare professionals perform in the pharmaceutical care procedures also has an essential importance as it ensures accessibility to the medication by offering, in coordination with the physician, health advice, pharmacotherapeutic monitoring and professional support for patients.

The challenge remains, much more in the current economic situation, to ensure the quality of delivery throughout the National Health System in a decentralized framework capable of promoting the rational use of medicines and in the the central objective is for all citizens to continue to have access to the medicine they need, when and where they need it, in terms of effectiveness and security.

II

The transfer of competences to the autonomous communities in the field of health is now a reality as the health decentralization provided for in Law 14/1986 of 25 April, General of Health, has been completed. Thus, since the beginning of 2002, all the autonomous communities have assumed the functions that they have been carrying out and the services that the National Institute of Health (INHEALTH) has been providing, which implies a complete decentralization of the health care of the National Health System, including the health care system.

The management of the autonomous communities in the field of health includes a broad spectrum of policies regarding priorities in the treatment of health problems, introduction of new technologies and new treatments, promotion of the most efficient alternatives in the diagnostic and therapeutic processes developed by the professionals of the respective autonomous communities, as well as in income policies affecting the remuneration and incentive systems Economic and social professionals and health centres, all within the broad scope of corresponds to the exercise of the competences assumed in the framework of the criteria established by Law 16/2003, of 28 May, of cohesion and quality of the National Health System, and other state regulations on the matter.

The pharmaceutical policies have established strategies aimed at intensifying the rational use of the drugs, and can highlight those aimed at providing quality, periodic and independent information to the health professionals to ensure adequate training on the rational use of medicinal products, reinforcing the requirement of the medical prescription as an essential document for the safety of the patient, or those relating to the modification of the prospects for medicines to make them intelligible to the citizens, helping the achieve the necessary adherence to treatment so that the therapeutic success provided by the doctor can be achieved with the necessary cooperation of the pharmacist.

It is necessary for our National Health System to guarantee to healthcare professionals that the information, training and commercial promotion of the drugs have as their core elements of their development scientific, transparency and ethics in the practice of these activities.

Although the drugs have made a decisive contribution to improving the quality of life of citizens, they sometimes pose problems of effectiveness and safety that must be known to the public. health professionals. For this reason, it is particularly important that this law grants the Spanish system of pharmacovigilance of the National Health System, with a more innovative approach, which incorporates the concept of pharmacoepidemiology and management of the risks, as well as the continued monitoring of the benefit/risk balance of authorised medicinal products.

The next few years draw a picture characterized by a significant increase in the population, but with a marked ageing of the population and, therefore, with greater health needs arising from this phenomenon, as well as the chronification of numerous pathologies. These needs must be ensured in a rigorous framework in terms of the safety and efficacy requirements of medicinal products for the benefit of the quality of care for citizens.

The sustained growth of the needs in the field of pharmaceutical supply will therefore necessarily have to be framed in strategies for the rational use of drugs and for the control of pharmaceutical expenditure that will allow continue to ensure a universal delivery of quality by contributing to the sustainability of the National Health System.

In this sense, the law considers it necessary that the selective and non-indiscriminate financing of drugs be carried out according to the therapeutic utility of the same and their need to improve the health of the citizens. It should be recalled that the appearance in these years of the generic drugs, of proven clinical efficacy and more economical, having expired the period of data exclusivity of the original medication, ensures identical quality conditions, security and efficiency at a lower price.

III

This recast text addresses all these aspects by incorporating the modifications produced in the subject since the entry into force of Law 29/2006, of July 26.

The first amendment of this law was introduced by Law 51/2007 of 26 December of the General State Budget for the year 2008, with the sole purpose of fixing the various rates of the tax for the benefit of the services and activities of the General Administration of the State in the field of medicinal products.

Two years later, Law 25/2009, of December 22, amending various laws for its adaptation to the Law on the Free Access to the Activities of Services and its Exercise, modified, among many other norms, the Law 29/2006, of 26 July, with the aim of adapting it to the provisions of Law 17/2009 of 23 November on the free access to and pursuit of the activities of services, and to delete unjustifiable or disproportionate requirements or obstacles with the clear objective of boosting economic activity.

Practically no solution of continuity was passed Law 28/2009, of December 30, of amendment of Law 29/2006, of July 26, of guarantees and rational use of the medicines and medical devices, with the object of consider the participation in the prescription of medicines and medical devices from other healthcare professionals other than physicians and dentists, as was the case for nurses and podiatologists.

As a result of the economic crisis launched in 2008, Law 29/2006 of 26 July has continued to undergo a number of changes. Some of them have been of a technical nature, such as those relating to the guarantees of efficacy, safety and quality of medicines and medical devices, but the most significant have occurred on the economic aspects, the most notable being the right to initiatives to control pharmaceutical expenditure. The need for this control did not only result in the forced efficiency in the management of public expenditure, especially in a situation of serious crisis, but such control was also necessary in terms of the technological improvement of the medicines themselves, as well as the emergence of new drugs, some of which introduced substantial advances in therapeutic treatment and therefore in the state of health. The positive technological evolution occurred when most of the countries of the world had incorporated into their legal systems the Agreements on the aspects of Intellectual Property Rights related to Trade (TRIPS). that in the pharmaceutical field means the full protection of patented discoveries. This phenomenon led to an increase in the prices required for pharmacological innovations, which, together with other factors, led to an increase in the budgets of pharmaceutical expenditure which grew above the parameters. that characterize the wealth of nations-Gross Domestic Product (GDP) per capita-or the level of development of the welfare state-a percentage of GDP dedicated to healthcare. Spain, where the coverage of pharmaceutical spending by the National Health System is very high, suffered more than other countries in the economic crisis, which forced the incorporation of efficiency policies in healthcare spending.

In this way, the containment of pharmaceutical expenditure required urgent reforms and, to this effect, several rules were enacted, in particular, the Royal Decree-Law 4/2010, of 26 March, of rationalisation of pharmaceutical expenditure with The National Health System, the Royal Decree-Law 8/2010 of 20 May, adopting extraordinary measures for the reduction of the public deficit, and one year later, the Royal Decree-Law 9/2011, of 19 August, of measures for improvement of the quality and cohesion of the National Health System, of contribution to fiscal consolidation and raising the maximum amount of State endorsements for 2011, which introduced general order discounts and limitations, affecting the supply of medicines.

The Royal Decree-Law 4/2010 of 26 March was the first reaction to the economic crisis which began years earlier and pursued the unpostponed objective of modifying the public funding of medicines and medical devices. provided for in Law 29/2006 of 26 July to facilitate the application of the reference price system and to introduce discounts and limitations that reduce the pharmaceutical expenditure under the National Health System.

The subsequent Royal Decree-Law 8/2010, of 20 May, addressed the establishment of measures complementary to those already adopted in the framework of the pharmaceutical provision to establish new deductions and price reductions.

The reference price system referred to in Law 29/2006, of 26 July, underwent a new variation by means of Law 34/2010 of 5 August of amendment of Laws 30/2007 of 30 October of Contracts of the Public Sector, 31/2007, of 30 October, on procurement procedures in the water, energy, transport and postal services sectors, and 29/1998, of 13 July, regulatory of the Jurisdiction-Administrative Jurisdiction adaptation to the Community rules of the first two, while the incompatibilities of the health professionals was also amended by Law 14/2011 of 1 June, of Science, Technology and Innovation.

Finally, Royal Decree-Law 9/2011 of 19 August aimed to generalise the prescription of medicinal products by active principle, to modify the reference price system, making it more agile and easy to manage, and to improve the criteria for selective financing of medicinal products, incorporating into the provision those which offer substantial improvements in treatment.

For its special importance in the area of the consolidation of public health provision, and not only in relation to the amendment of Law 29/2006, of 26 July, to which it dedicated its Chapter IV, the Real Decree-Law 16/2012 of 20 April, of urgent measures to guarantee the sustainability of the National Health System and improve the quality and safety of its benefits, a norm that addressed a substantial reform of global character introducing reforms on demand. The reform introduced rationalises pharmaceutical funding by excluding the public funding of medicinal products intended for the treatment of minor symptoms, introduces a structural modification to the system of fixing prices of medicinal products, with an innovative scheme of selected prices, marking a shift towards selective financing with criteria such as cost-effectiveness and the assessment of budgetary impact, alongside other qualitative elements which have allowed the portfolio of funded medicines to be modular. And, as a measure of greater social importance, it is clear that it is consistent to establish the contribution of beneficiaries to pharmaceutical expenditure according to their economic capacity, seeking a more responsible use of the benefit as well as a more equitable and sustainable distribution of the funding effort, thereby improving the system initially maintained by Law 29/2006 of 26 July, which was the current one since the 1980s.

A further amendment of Law 29/2006, dated 26 July, took place through Royal Decree-Law 28/2012 of 30 November, of measures to consolidate and guarantee the Social Security system, which redefined the provision of services. Ambulatory pharmaceutical considering as such the one that is dispensed to the patient by medical prescription or order of hospital dispensation through offices or pharmacy services.

The last draft reform of Law 29/2006, of July 26, was the one operated by Law 10/2013, of July 24, which precisely incorporated the authorization of the General Courts to the Government for the approval of this recast text. The main purpose of this law was to incorporate into the Spanish legal order Directives 2010 /84/EU of the European Parliament and of the Council of 15 December 2010 on pharmacovigilance and 2011 /62/EU of the European Parliament and of the European Parliament. Council of 8 June 2011 on the prevention of the entry of falsified medicinal products into the legal supply chain. However, beyond the satisfaction of this purpose, other substantial aspects of the law have been modified, not to mention the European standards, among which the technical adaptation of the sanctioning procedure and the regime of the public revenue from actions by the Spanish Agency for Medicines and Health Products or the introduction of a series of improvements consisting in extending the regime so far applicable to medicinal products for human use also to the medicines for veterinary use, medical devices, cosmetics and care products in order to provide a comprehensive general regulation within the framework of Law 29/2006 of 26 July, without prejudice to the corresponding regulatory developments. In addition, in order to speed up the pharmaceutical sector, some forecasts were incorporated which, until then, were to be notified, in so far as this is possible, since the It is certainly not the only mechanism for monitoring the activities referred to in Law 29/2006 of 26 July. Finally, a relevant change in the therapeutic positioning report was introduced as a key tool in the correct and efficient use of new drugs.

Finally, the last amendment of Law 29/2006, of 26 July, prior to the approval of this recast text, has been the one operated by Law 36/2014, of December 26, of General State Budgets for the year 2015, to amend two fees for the provision of services and to carry out activities of the General Administration of the State in the field of medicinal products, medical devices, cosmetic products and personal care products.

IV

Tight synthesis shows the desirability of framing the sustained growth of the needs in the field of pharmaceutical delivery within strategies of rational use of drugs and control of expenditure Pharmaceutical products that allow to continue to ensure a universal delivery of quality, contributing to the sustainability of the National Health System at specific times of economic difficulty and technological change.

The normative integration of all the changes operated in this matter requires a necessary systematic unification so, according to the authorization contained in the fourth final provision of Law 10/2013, 24 July, this recast text is approved in accordance with the criteria set out below.

First of all, all the amendments in force introduced in Law 29/2006 of 26 July have been incorporated into a single text through various laws which have given new wording to certain precepts or which have introduced new provisions to that. As a result of the above, and under the authority granted to regularise, clarify and harmonise the legal texts to be recast, the location and numbering of the articles, as well as the referrals and concordance, have been adjusted. among them, and some terms used in it have been homogenized.

It should be clarified that, in compliance with this legislative delegation, only those provisions of the legal texts that have expressly amended Law 29/2006 of 26 July, giving new legal texts are regulated, clarified and harmonised. drafting or including new provisions to this law, since the legislator has clearly established as a regulatory framework the consolidation of the various rules which have amended Law 29/2006 of 26 July, which is not extensible, as a result, to legal norms that have not given new wording or that have not incorporated new ones precepts to it.

On the other hand, and in addition to this power granted to the Government, other rules have been taken into account, the application of which required the adaptation of certain aspects contained in Law 29/2006 of 26 July. These are aspects such as the elimination of the forecast to update certain amounts or amounts according to the Index of Consumer Prices, in application of Law 2/2015 of 30 March, of de-indexation of the Spanish economy, or the updating of the amount of the fees in accordance with the provisions of Law 36/2014 of 26 December 2014.

The same has not happened, however, with the adaptation to the Law 20/2013, of December 9, of guarantee of the market unit, since a comprehensive review of Law 29/2006, of July 26, to adapt it to that would have exceeded of the habilitation granted to regularise, clarify and harmonize the legal texts to be recast. However, it should be made clear that the approval of this recast text does not, of course, constitute an obstacle to continued work on a general review of the text in order to adapt it to the criteria laid down by Law 20/2013, 9 December, revision which, in any case, must be subject to the usual channels and procedures for the modification of legal provisions.

Finally, and under the authorisation received, the additional, transitional and final provisions of Law 29/2006 of 26 July have been revised and amended due to the need to adapt their content to the elapsed time. from its approval and its successive amendments.

Thus, the content of the additional twelfth provision, relating to the participation of nurses in the field of medicinal products subject to medical prescription, has been incorporated, for systematic reasons, in Article 79 of the this text recast by its intimate connection to it.

As regards the transitional provisions of Law 29/2006 of 26 July, some of them, in particular, the numbered as fourth, fifth, sixth, seventh and ninth, have not been included in the recast text as the duration of the temporary space provided for in them. These are, respectively, those relating to the adaptation of authorizations to carry out distribution activities, to the time limit laid down for the inclusion of indications in alphabet braille in the packaging and prospectuses of medicinal products, of the In the case of Gallic innovations, the indication of the period in which the system of contributions to the National Health System referred to in the sixth provision is to be applied and, finally, the period relating to the period for the adaptation of certain information guarantees.

Furthermore, the content of other provisions appearing as transitional in that law, in particular, numbered as a third and eighth, are incorporated in the recast text as additional provisions. Fifteenth and sixteenth, as their content is more or less of a provision of these characteristics. These are, respectively, those relating to the application of the periodic safety report to the authorisations of medicinal products which are renewed after the entry into force of Law 29/2006 of 26 July and the application of the system of pricing in the medical devices authorised prior to the entry into force of that law.

Finally, the corresponding adequacy of the final disposition has been made to adapt the reference of the competences in base to which each of the subjects covered by this norm is regulated to the new structure of the same.

This royal legislative decree, on which the affected sectors have been granted a hearing, has been subject to consultation both by the Autonomous Communities and Cities of Ceuta and Melilla, and by the Spanish Federation of Municipalities. and Provinces.

In addition, it has been informed by the Economic and Social Council, by the National Commission of Markets and Competition, by the Spanish Data Protection Agency, by the Council of Consumers and Users and by the Consultative and the Interterritorial Council of the National Health System.

In its virtue, on the proposal of the Minister of Health, Social Services and Equality, in agreement with the Council of State and after deliberation of the Council of Ministers, at its meeting of 24 July 2015,

DISPONGO:

Single item. Approval of the recast text of the Law on guarantees and the rational use of medicinal products and medical devices.

The recast text of the Law on the guarantees and rational use of medicinal products and medical devices is approved, the text of which is inserted below.

Single additional disposition. Regulatory referrals.

The regulatory references made in other provisions of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices shall be construed as referring to the relevant provisions of the text. Recast to be approved.

Single repeal provision. Regulatory repeal.

The provisions of this law, and in particular Law 29/2006 of 26 July, of guarantees and the rational use of medicinal products and medical devices, shall be repealed as many provisions of the same or lower rank. the exception of its second, third and fourth final provisions.

Single end disposition. Entry into force.

This royal legislative decree and the recast text that it approves will enter into force on the same day as its publication in the "Official State Gazette".

Given in Madrid, on July 24, 2015.

FELIPE R.

The Minister of Health, Social Services and Equality,

ALFONSO ALONSO ARANEGUI

PRELIMINARY TITLE

General provisions

Article 1. Purpose and scope of the law.

This law regulates, in the field of competencies that correspond to the State:

(a) medicinal products for human use and medical devices, their clinical investigation, their assessment, authorisation, registration, manufacture, production, quality control, storage, distribution, circulation, traceability, marketing, information and advertising, import and export, prescription and supply, monitoring of the risk-benefit ratio, as well as the management of its rational use and the procedure for, where appropriate, financing with funds public. The regulation also extends to the substances, excipients and materials used for their manufacture, preparation or packaging.

(b) The action of natural or legal persons involved in the industrial or commercial circulation and in the prescription or dispensing of medicinal products and medical devices.

(c) The general criteria and requirements applicable to veterinary medicinal products, and in particular to special ones, such as master formulae, and those relating to industrially manufactured products, including premixtures for medicated feed.

(d) Cosmetics and personal care products, and in particular the precautionary measures and the regime of infringements and penalties applicable to them.

Article 2. Definitions.

For the purposes of this law:

(a) "Human use medicinal product" means any substance or combination of substances which is present as a property holder for the treatment or prevention of diseases in humans or which can be used in humans or be administered to humans in order to restore, correct or modify physiological functions by exercising pharmacological, immunological or metabolic action or to establish a medical diagnosis.

(b) "veterinary medicinal product" means any substance or combination of substances which is present as a holder of curative or preventive properties in respect of animal diseases or which may be administered to the animal for the purpose of to restore, correct or modify its physiological functions by exerting a pharmacological, immunological or metabolic action or to establish a veterinary diagnosis. 'Veterinary medicinal products' shall also be considered as 'medicated feed premixtures' prepared to be incorporated into a feed.

(c) "active substance" or "active substance" means any substance or mixture of substances intended for the manufacture of a medicinal product and which, when used in its production, are converted into an active component of that medicinal product intended to exercise pharmacological, immunological or metabolic action in order to restore, correct or modify physiological functions, or to establish a diagnosis.

(d) "Excipient" means any component of a medicinal product other than the active substance and conditioning material.

(e) "Raw material": Any substance-active or inactive-used in the manufacture of a medicinal product, whether unchanged, modified or removed during the course of the process.

(f) "Galenic form" or "pharmaceutical form": The provision to which the active substances and excipients are adapted to constitute a medicinal product. It is defined by the combination of the way in which the pharmaceutical product is presented by the manufacturer and the way in which it is administered.

g) "Generic medicinal product": Any medicinal product having the same qualitative and quantitative composition in active substances and the same pharmaceutical form, and whose bioequivalence with the reference medicinal product has been demonstrated by adequate studies of bioavailability. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance shall be considered to be the same active substance, unless they have significantly different properties in terms of safety and/or efficacy. The different oral pharmaceutical forms of immediate release will be considered as the same pharmaceutical form. The applicant may be exempt from presenting the bioavailability studies if it can demonstrate that the generic medicinal product satisfies the relevant criteria as defined in the relevant detailed guidelines.

h) "Intermediate product": The intended for a subsequent industrial transformation by an authorized manufacturer.

(i) "Master Formula": The medicinal product intended for an individual patient, prepared by a pharmacist or under his/her address, to expressly complete a detailed optional prescription of the active substances which includes, in accordance with the rules of correct quality and quality control established for the purpose, dispensed in the office of pharmacy or pharmaceutical service and with due information to the user in the terms provided for in Article 42.5.

(j) "Official preparation": a medicinal product prepared in accordance with the rules of correct production and quality control established for the purpose and guaranteed by a pharmacist or under his/her address, dispensed in a pharmacy or pharmaceutical service, listed and described by the National Form, intended for direct delivery to the sick to whom the pharmacy or pharmaceutical service supplies.

k) "investigational medicinal product": A pharmaceutical form of an active substance or a placebo that is investigated or used as a reference in a clinical trial, including products with authorisation when used or combined, in the formulation or packaging, in a different way than the authorised one, or when used to treat an unauthorised indication or for more information on an authorised use.

(l) "Health product" means any instrument, device, equipment, software, material or other article, used alone or in combination, including software intended by its manufacturer for purposes specific diagnosis and/or therapy and which are involved in their proper functioning, intended by the manufacturer to be used in human beings for the purpose of:

1. º Diagnosis, Prevention, Control, Treatment or Relief of a Disease;

2. º diagnosis, control, treatment, relief, or compensation for an injury or deficiency;

3. research, replacement or modification of the anatomy or a physiological process;

4. Regulation of conception,

and do not exercise the main action that you want to obtain inside or on the surface of the human body by pharmacological, immunological or metabolic means, but whose role such media can contribute.

m) "Personal care product": substances or mixtures which, without the legal consideration of medicinal products, medical devices, cosmetics or biocidal products, are intended to be applied on the skin, teeth or mucous membranes of the body human for the purpose of hygiene or aesthetics, or to neutralize or remove ectoparasites.

n) "cosmetic product" means any substance or mixture intended to be brought into contact with the surface parts of the human body (epidermis, hair and hair system, nails, lips and external genital organs) or with teeth and Mouth mucous membranes, for the sole or main purpose of cleaning, perfuming, modifying their appearance, protecting them, keeping them in good condition or correcting body odours.

o) "Counterfeit medication": Any medication whose presentation is false with respect to:

1. Your identity, including the packaging and labelling, the name or composition in respect of any of its components, including the excipients, and the dosage of such components;

2. the origin, including the manufacturer, the country of manufacture, the country of origin and the marketing authorisation holder; or,

3. your history, including records and documents relating to the distribution channels used.

This definition does not include inadvertent quality defects and is without prejudice to violations of intellectual property rights.

p) "Wholesale distribution of medicinal products" means any activity consisting of obtaining, storing, preserving, supplying or exporting medicinal products, excluding the supply to the public of such medicinal products.

q) "Contract Store": Entity acting as a third party, with which a laboratory or a wholesale warehouse subscribes to a contract to perform certain drug distribution activities.

r) "Drug Intermediation": All activities relating to the sale or purchase of medicinal products, with the exception of those included in the definition of wholesale distribution, as defined in this Article, which does not they include physical contact with them and that they consist of the negotiation independently and on behalf of another legal or natural person.

TITLE I

General Warranties and Obligations

Article 3. Supply and supply guarantees.

1. The pharmaceutical laboratories, distribution entities, importers, pharmacy offices, pharmacy services of hospitals, health centers and other health care structures are obliged to supply or to dispense the drugs and sanitary products which are requested under the legal and regulatory conditions laid down.

2. Those responsible for the production, distribution, sale and supply of medicinal products and medical devices shall respect the principle of continuity in the provision of service to the community.

3. The Government, in order to ensure the supply of medicinal products, may adopt special measures in relation to its manufacture, import, distribution and supply. In the case of 'orphan medicinal products', as provided for in Regulation (EC) No 141/2000 and 'medicinal products without commercial interest', the Government may adopt, in addition to the measures indicated, those relating to the economic and fiscal arrangements for such medicinal products. For these purposes, as well as those provided for in Article 121.1, 'medicinal products without commercial interest' means those of which there is no or insufficient supply on the domestic market, and are necessary for the treatment of certain diseases or pathologies.

4. The prescription and dispensing of medicinal products and medical devices shall be carried out in accordance with the basic criteria of rational use laid down in this law.

5. The sale, by correspondence and by telematic procedures, of medicinal products and medical devices subject to prescription is prohibited. The implementing rules shall lay down the applicable requirements and shall regulate those arrangements for sale in respect of medicinal products which are not subject to prescription, while ensuring that medicinal products for human use are dispensed by an office. Authorised pharmacy, with the intervention of a pharmacist, after having been provided with personalised advice as provided for in Articles 19.4 and 86.1, and with compliance with the rules applicable on the basis of medicinal products for sale or for use for the sale and fulfilment of the information requirements set out in the Law 34/2002, of 11 July, of information society and electronic commerce services and, in the case of veterinary medicinal products, are dispensed by one of the establishments described in paragraphs (a) and (b) of Article 38.2, with the A pharmacist must also comply with the requirements laid down in Law 34/2002 of 11 July.

It is also prohibited to sell at home and any type of indirect sale to the public of medicines. Health administrations may, for reasons of public health or safety, limit, condition or prohibit the sale of products to the public at home and any type of indirect sale to the public of medical devices.

The provisions of this paragraph are without prejudice to the distribution, distribution or supply to entities legally authorized to dispense with the public.

The development rules will lay down the requirements for them to be sold directly to medical, dental, veterinary and podiology professionals, exclusively, the necessary medicines for the exercise of their professional activity.

6. The custody, conservation and dispensing of medicinal products for human use shall be exclusively:

a) To the legally authorized offices of pharmacy open to the public.

b) To the pharmacy services of the hospitals, health centers and primary care structures of the National Health System for their application within these institutions or for the drugs that require a particular surveillance, supervision and control of the multidisciplinary health care team, in accordance with the qualification granted by the Spanish Agency for Medicines and Health Products for such medicinal products.

(c) In addition to the medicinal products specified in paragraph (b), in the field of the National Health System, the pharmacy services of the hospitals shall be responsible for the custody, preservation and dispensing of medicinal products for use. The Ministry of Health, Social Services and Equality agrees to establish unique reserves, limiting their dispensation without the need for a visa for non-hospitalized patients.

However, in the case of clinical trials carried out in research centres which do not have pharmacy services, it is possible to send the investigational medicinal products to the research centre, The investigator of that center assumes the responsibilities regarding the correct administration, custody and delivery of these medications according to the protocol of the study.

7. The dispensing, sale or marketing of any drug that is returned or delivered by patients, or the general public, to pharmacy offices is prohibited.

Article 4. Guarantees of independence.

1. Without prejudice to the incompatibilities established for the exercise of public activities, the clinical practice of medical, dental, veterinary and other health professions with the right to prescribe or indicate the dispensing of medicinal products shall be incompatible with any kind of direct economic interest arising from the manufacture, manufacture, distribution, intermediation and marketing of medicinal products and medical devices. This is the exception of the provisions of Law 14/2011 of 1 June, of Science, Technology and Innovation, regarding the participation of the staff of the research centers that are dependent on the Public Administrations in the entities created or participated by those entities, with the intended object in the same.

2. In addition, the professional practice of the pharmacist in the office of pharmacy, in the retail establishment, in livestock groups or in a hospital pharmacy service and other care structures shall be incompatible with the any class of direct economic interests of the pharmaceutical laboratories, intermediation entities and/or distribution entities.

3. The clinical practice of medical, dental, veterinary and other health professions with the right to prescribe or indicate the dispensing of medicinal products shall be incompatible with the performance of professional activity or with the ownership of pharmacy office.

4. The membership of the committees of the Spanish Agency for Medicines and Health Products, the Ethical Committees of Clinical Research or the committees or advisory bodies established by the health administrations of the communities It shall be incompatible with any class of interests arising from the manufacture and sale of medicinal products and medical devices.

5. The exercise of the health professionals involved in the cycle of prescription, dispensing and administration of medicinal products shall be incompatible with the functions of medical visit delegates, representatives, commission agents or agents of pharmaceutical laboratories.

6. For the purpose of ensuring the independence of decisions relating to the prescription, dispensing and administration of medicinal products in respect of commercial interests, the direct or indirect offer of any incentive shall be prohibited, bonuses, discounts, premiums or gifts by those who have direct or indirect interests in the production, manufacture and marketing of medicinal products to healthcare professionals involved in the cycle of prescription, supply and medication administration or to your relatives and people of coexistence. This ban will also apply when the offer is made to healthcare professionals who prescribe medical devices. Except for the previous prohibition, the discounts for early payment or for the volume of purchases made by the distributors to the offices of pharmacy. They will be able to reach up to a maximum of 10% for the medicines financed from the National Health System, provided that the purchase of a product is not incentivised against that of its competitors and will be reflected in the corresponding invoice.

Article 5. Guarantees of the defence of public health.

1. The manufacture, manufacture, import, export, distribution, placing on the market, prescription and supply of products, preparations, substances or combinations thereof, which are presented as medicinal products without legal status, is prohibited. recognized as such.

2. The promotion, publicity or information intended for the public of the products listed in paragraph 1 is expressly prohibited.

3. The provisions laid down in the preceding paragraphs shall apply to products which are presented as medical devices or as cosmetic products without such consideration, as well as to medical devices and cosmetic products which are market without having followed the procedures set out in their specific regulations.

4. Failure to comply with the above prohibitions shall give rise to the responsibilities and penalties provided for in Chapter II of Title IX, irrespective of the precautionary measures that they have taken and the civil or criminal liability to which the place.

Article 6. Obligations of the Public Administrations and participation of professionals.

1. For the purposes of safeguarding public health and safety requirements, public administrations are obliged to communicate how much data, actions or information is derived from the exercise of their powers and are necessary for the correct application of this law.

2. All professionals who provide their services in the National Health System or in the public system of scientific research and technological development in Spain have the right to participate and the duty to collaborate with the administrations. health in the assessment and control of medicinal products and medical devices.

3. The committees and committees provided for in this law shall comply with the provisions of the provisions in force.

Article 7. Transparency in the adoption of decisions by health administrations.

Health administrations will ensure maximum transparency in the processes of adoption of their decisions in the field of medicines and medical devices, without prejudice to the right of industrial property. Participation in such decision-making processes shall be incompatible with any kind of personal interest arising from the manufacture, marketing, representation, distribution and sale of medicinal products and products. health.

TITLE II

Of the drugs

CHAPTER I

Of the drugs recognized by law and their classes

Article 8. Legally recognised medicinal products.

1. Only those listed below will be medicines:

(a) medicinal products for human and veterinary use manufactured industrially or in the manufacture of which an industrial process is involved.

b) The master formulas.

c) Official preparations.

d) Special medications provided for in this law.

2. They shall have the legal treatment of medicinal products, for the purposes of the application of this law and of their general control, the substances or combinations of substances authorised for use in clinical trials or for animal research.

3. It is up to the Spanish Agency for Medicines and Health Products to resolve the attribution of the medicinal product.

4. Secret remedies are banned. The products in respect of which their composition and characteristics are not known shall be classified as secret.

5. It is mandatory to declare to the health authority all known characteristics and properties of the medicinal products.

6. In case of doubt, when a product can respond to the definition of a medicinal product, this law will apply to it, even if the product could be applied to the definition provided for in another standard.

CHAPTER II

Of the guarantees required for medicinal products for human use manufactured industrially and for the conditions of prescription and dispensing of the same

Article 9. Authorization and registration.

1. No medicinal product manufactured industrially may be placed on the market without the prior authorization of the Spanish Agency for Medicines and Health Products and registration in the Register of Medicinal Products or without obtaining the authorization of compliance with the provisions of European standards laying down Community procedures for the authorisation and control of medicinal products for human and veterinary use and which is regulated by the European Medicines Agency.

2. When a medicinal product has obtained an authorisation in accordance with the above paragraph, any dosage, pharmaceutical form, route of administration and additional presentations, as well as any other modifications and extensions to the dossier of the authorization to be introduced, shall be the subject of authorization or notification as provided for in the rules governing the procedure for the authorization, registration and conditions for the supply of medicinal products for human use manufactured industrially. All such modifications shall be considered as belonging to the same global marketing authorisation, in particular for the purposes of the application of the data exclusivity periods.

3. Any modification, transmission and termination of the authorization of medicinal products shall be recorded in the Register of Medicinal Products which, in the same way as the registration, shall have a constituent character.

4. The Spanish Agency for Medicinal Products and Sanitary Products shall proceed on its own initiative to the incorporation into the Register of Medicinal Products of the authorisations granted by the European Commission in accordance with Regulation (EC) No 726 /2004/EC.

Article 10. Guarantees required for the authorisation of medicinal products.

1. The Spanish Agency for Medicines and Health Products shall grant authorization to a medicinal product if it satisfies the following conditions:

a) Reach the quality requirements that are set.

b) Be safe, not producing under normal conditions of use toxic or undesirable effects disproportionate to the benefit it seeks.

c) Be effective in the therapeutic indications for which it is offered.

d) Be correctly identified.

e) Provide accurate information, in accessible format and in an understandable way by the patient, for proper use.

2. The assessment of the positive therapeutic effects of the medicinal product shall be assessed in relation to any risk related to the quality, safety and efficacy of the medicinal product for the health of the patient or public health, benefit/risk ratio.

3. The provisions of this Article shall also apply to changes in the authorisation and shall be observed throughout the life of the medicinal product.

4. The holder of the authorisation or, where appropriate, the manufacturer must have the material and personal means, the organisation and the operational capacity sufficient for its correct manufacturing.

Article 11. Quality assurance.

1. Any medicinal product must have its qualitative and quantitative composition perfectly established. Alternatively, in the case of substances such as biological substances where this is not possible, their preparation procedures should be reproducible.

2. The person holding the Ministry of Health, Social Services and Equality shall establish the type of checks required from the marketing authorisation holder and the manufacturer to ensure the quality of the raw materials, intermediate products, the manufacturing process and the final product, including packaging and storage, for the purposes of authorisation and registration, while maintaining such controls for the duration of the production and/or placing on the market of the medicinal product. Quality control procedures shall be modified in accordance with the progress of the technique.

3. The Spanish Royal Pharmacopoeia is the code that establishes the quality that the active substances and excipients that enter into the composition of the medicinal products for human and veterinary use. It will be regularly updated and published.

The Ministry of Health, Social Services and Equality, through the Spanish Agency for Medicines and Health Products, will set and publish in the "Official State Gazette" the date of the entry into force of the successive volumes of the Spanish Royal Pharmacopoeia.

4. The Spanish Pharmacopoeia is constituted by the monographs contained in the European Pharmacopoeia of the Council of Europe and, in justified cases, by the peculiar Spanish monographs. For substances manufactured in countries belonging to the European Union, the European Pharmacopoeia, the monograph of the pharmacopoeia of the manufacturer country and, failing that, that of a third country, is governed by the European Pharmacopoeia. The Pharmacopoeia shall include monographs conveniently ordered and coded with the identity, purity and richness specifications of at least the active substances and excipients, as well as the official analytical methods and general texts necessary for the correct application of the monographs. The specifications set out in the monographs are minimum requirements for compliance. Any raw material presented under a scientific or common name of the Pharmacopoeia in force must be in response to the specifications of the Pharmacopoeia. The Ministry of Health, Social Services and Equality will be able to recognize the existence of specific monographs of foreign drugs in Spain.

5. The offices of pharmacy, pharmaceutical services, distribution entities and pharmaceutical laboratories must ensure that they have access to the Spanish Royal Pharmacopoeia.

6. The Spanish Agency for Medicinal Products and Health Products and the Autonomous Communities shall establish quality control programmes for medicinal products in order to verify compliance with the conditions of the authorization and of the other application. For the purposes of coordination of such programmes, unit criteria relating to the extent, intensity and frequency of the controls to be carried out shall be established in the framework of the Interterritorial Council of the National Health System.

7. Health authorities and professionals and laboratories and distributors are required to collaborate diligently on the above quality control programs and communicate the anomalies of which they have knowledge.

Article 12. Security guarantees.

1. Medicinal products, active substances and raw materials consisting of those products shall be the subject of toxicological and clinical studies to ensure their safety under normal conditions of use and which shall be in relation to the intended duration of the treatment.

2. The toxicological studies shall include tests for acute and chronic toxicity, teratogenic tests, embryotoxicity, fertility, mutagenesis and, where appropriate, carcinogenicity tests and, in general, those considered necessary for a correct assessment of the safety and tolerance of a medicinal product under normal conditions of use and depending on the duration of the treatment. In any case, the rules on the protection of animals used for scientific purposes shall be complied with. These studies should be carried out in accordance with established good laboratory practice.

3. In addition to the toxicological studies and clinical trials, the applicants for the authorisation shall demonstrate the ability to carry out appropriate post-marketing surveillance of the safety of the medicinal product. They shall also present the specific pharmacovigilance and risk management plans which, in accordance with the national and European guidelines, are deemed necessary, as well as the effective commitment to the development and implementation of the same.

4. The safety guarantees for the medicinal product shall be extended to the risks related to its use and in particular to any risk of undesirable effects to the environment.

5. Without prejudice to their own responsibility, all health authorities and professionals as well as pharmaceutical laboratories and distribution entities are required to work diligently in the knowledge of product safety. In addition, healthcare professionals, pharmaceutical laboratories and distribution entities are obliged to communicate to the health authorities the anomalies of the health authorities, in accordance with the provisions of Chapter VI of this Regulation. title.

Article 13. Guarantees of effectiveness.

1. The efficacy of the medicinal products for each of their indications must be established on the basis of the prior performance of preclinical studies and clinical trials which will comply with the regulatory requirements and those resulting from the progress made in the scientific knowledge of the subject.

2. Animal studies shall be designed and carried out in such a way as to enable the overall pharmacological profile of the substance to be known. In any case, the rules on the protection of animals used for scientific purposes shall be complied with.

3. Clinical trials shall be planned and carried out in such a way as to enable the necessary information to be obtained for the performance of the substance in the body and to assess the efficacy of the medicinal product. The therapeutic effect should be quantified for the different doses and in all the indications requested. In all trials, the ethical requirements established for research with human beings shall be respected.

Article 14. Identification guarantees.

1. A Spanish official name (DOE) will be assigned to each active principle by the Spanish Agency for Medicines and Health Products. The official Spanish name shall be compulsory, without prejudice to the possibility of expressing, in addition, in the corresponding official languages of the Autonomous Communities.

The official Spanish name must be equal, or as approximate as possible, to the linguistic needs, to the international name (INN) fixed by the World Health Organization.

The official Spanish denominations of the active principles will be in the public domain. The Spanish Agency for Medicinal Products and Sanitary Products will publish a list of the official Spanish names of the active substances authorised in Spain, which will be updated regularly.

Public bodies shall promote the use of the official Spanish denominations, if they exist, or, failing that, of the international denominations or, in the absence thereof, of the usual names or

2. The name of the medicinal product may consist of a name of fantasy which cannot be confused with the common name or in a common or scientific name accompanied by a trade mark or the name of the holder of the authorization marketing.

The name of the medicinal product may not be confused with an official Spanish name or with an international name or be misleading about the therapeutic properties or the nature of the medicinal product.

Generic medicinal products must be designated with a Spanish official name of active substance and, failing that, with the international name or, if not, the common name of the usual name or Scientific evidence of that substance, accompanied, where appropriate, by the name or mark of the holder or manufacturer; they may also be referred to as a trade mark provided that it cannot be confused with a Spanish official name or a common name or induce error on the therapeutic properties or the nature of the medicinal product.

Those medicines to be determined by the Spanish Agency for Medicines and Health Products may be identified with the acronym EFG (Generic Pharmaceutical Equivalent), due to their interchangeability.

3. The Ministry of Health, Social Services and Equality shall establish a National Drug Code of general application which facilitates its early identification and may require that its numbers or keys be included in the labelling of medicinal products.

Article 15. Information guarantees.

1. The Ministry of Health, Social Services and Equality shall regulate the aspects relating to the guarantees of information and, in particular, the characteristics, extent, details and places to be included. In any case, for the preparation of this information on the medicinal product, the holder shall provide sufficient written information on his identification, indications and precautions to be observed in his employment. This information shall be submitted, at least, in the official Spanish language of the State and the technical information sheet, package leaflet and the label shall be drawn up.

The texts and other characteristics of the technical information sheet, the package leaflet and the labelling form part of the authorization of the medicinal products and must be authorized by the Spanish Agency for Medicinal Products and Products. Sanitary. Their amendments shall also require prior authorisation or notification, as appropriate.

2. The technical information sheet or summary of the product characteristics shall reflect the authorised conditions of use for the medicinal product and synthesise the essential scientific information for healthcare professionals. The Spanish Agency for Medicinal Products and Health Products shall approve the technical information sheet containing sufficient data on the identification of the medicinal product and its holder and the therapeutic indications for which the medicinal product has been approved, in accordance with the studies supporting their authorisation. The technical information sheet shall be accompanied, preceptively, with up-to-date information on the price of the medicinal product and, where possible, the cost estimate of the treatment.

The Spanish Agency for Medicines and Health Products will make the technical information available to the health services of the Autonomous Communities, of the schools or professional organizations, of the doctors, dentists, podiatrists and pharmacists in exercise and, where appropriate, of the veterinary surgeons in the exercise. The holder of the authorisation shall be obliged to make the updated technical information available to the health authorities and the professionals in all their promotional activities and information in the established terms regulentarily.

3. The package leaflet, which shall be drawn up in accordance with the content of the information sheet, shall provide patients with sufficient information on the name of the active substance, identification of the medicinal product and its holder and instructions for its use. administration, employment and conservation, as well as adverse effects, interactions, contraindications, in particular the effects on the driving of motor vehicles, and other data to be determined on a regulatory basis in order to promote their more correct use and enforcement of the prescribed treatment, as well as the measures to be taken in the event of poisoning. The package leaflet must be legible, clear, ensuring its understanding by the patient and minimizing the technical nature.

4. The labelling shall include the particulars of the medicinal product, such as the name of the active substance, the holder of the authorisation, the route of administration, the quantity of the product, the number of production batch, the date of expiry, the precautions for storage, conditions of supply and other data which are regulated. In each package, the data of the National Medicines Code, the batch and the unit shall be coded, which shall be individually identified by mechanical, electronic and computer means, in the manner determined Regulation. A blank space to be filled in by the pharmacist should be included in the package, where the pharmacist may describe the dosage, duration of treatment and frequency of seizures. When dispensing a medicinal product, the pharmacy offices must issue a receipt stating the name of the medicinal product, its selling price to the public and the patient's contribution. In the case of medicinal products which are the subject of the advertising provided for in Article 80, the receipt shall also contain the discount which, if appropriate, had been made.

5. In order to ensure access to information for blind and visually impaired persons, the data necessary for the correct identification of medicinal products must be printed in the alphabet on all packages of medicinal products. The authorisation holder shall ensure that, upon request of the associations of affected patients, the package leaflet is available in appropriate formats for blind or partially sighted persons.

6. Medicinal products shall be developed and presented in such a way as to ensure the reasonable prevention of accidents, especially in relation to children and persons with disabilities. The packages shall bear, where appropriate, any sealing device which guarantees the user that the medicinal product maintains the composition, quality and quantity of the product packaged by the laboratory. The packaging shall also include the symbol authorised by the Spanish Agency for Medicinal Products and Sanitary Products for the purpose of facilitating the application and development of the system for the collection of residues of medicinal products and promoting the protection of the environment.

Article 16. Authorisation procedure and amendments thereto. Requirements and guarantees of transparency.

1. The Spanish Agency for Medicinal Products and Sanitary Products may require the applicant to provide documentation, studies, data or additional information, the Community legislation being applicable, the specific development of the law and, failing that, the regulatory rules of the common administrative procedure.

2. In the procedure for the evaluation of medicinal products, the Spanish Agency for Medicinal Products and Health Products shall, for the purposes of issuing the relevant reports, have committees or advisory bodies incorporating experts. qualified from the scientific and professional world.

3. In the authorisation procedure, the medicinal product, its raw materials, intermediate products and other components may be submitted for examination by the official control laboratories of the Spanish Agency for Medicinal Products and Health Products, which may request the collaboration of another national laboratory accredited for that purpose by the Agency itself, an official Community control laboratory or a third country.

4. In order to ensure the transparency of its actions, the Spanish Agency for Medicines and Health Products will ensure public access to its decisions on the authorisation of medicinal products, their modifications, suspensions and revocations, when all of them are firm, as well as the summary of product characteristics. The reasoned assessment report shall also be publicly accessible, subject to the deletion of any commercial information of a confidential nature. Confidentiality shall not prevent the publication of the acts of decision of the technical and scientific advisory bodies of the Ministry of Health, Social Services and Equality relating to the authorisation of medicinal products, their modifications, suspensions, and revocations.

Article 17. Authorization file.

1. The dossier for the authorisation of a medicinal product shall consist of all documentation relating to administrative information, summaries of experts, chemical, pharmaceutical and biological information for medicinal products containing chemical active substances. and/or biological, the result of the pharmaceutical, pre-clinical and clinical trials, and any other that is determined by regulation. The applicant or holder of an authorisation shall be responsible for the accuracy of the documents and data presented.

2. The application for authorisation of medicinal products shall include, among the identification data, the complete and accurate qualitative and quantitative composition, including not only active substances, but also all excipients and solvents, although the latter disappear in the manufacturing process.

The application will also include indications on the precautionary and safety measures to be taken when the medicinal product is stored, when administering it to patients, and when removing residual products, together with the indication of any potential risks that the medicinal product could present for the environment.

In the application, it shall be established that the applicant has a qualified person responsible for pharmacovigilance, as well as the necessary infrastructure to report on any adverse reactions suspected to have already occurred. produced or can be produced.

3. The applicant shall have no obligation to provide the results of the pre-clinical and clinical trials established if it can demonstrate that the medicinal product is generic of a reference medicinal product which has been or has been authorised for eight years as minimum in any Member State of the European Union, or by the European Union, even where the reference medicinal product is not authorised in Spain, without prejudice to the right of protection of industrial and commercial property.

4. Where a biological medicinal product similar to a reference biological product does not meet the conditions of the definition of a generic medicinal product, due in particular to differences related to raw materials or differences in the process for the manufacture of the biological medicinal product and the reference biological medicinal product, the results of the appropriate pre-clinical or clinical trials relating to those conditions and other regulatory requirements shall be provided.

5. The applicant may replace the results of the clinical trials and the preclinical studies with an appropriate literature-scientific literature if it can demonstrate that the active substances of the medicinal product have had a good medical use. established at least for 10 years within the European Union and have recognised effectiveness and an acceptable level of safety.

6. In the case of a medicinal product having the same qualitative and quantitative composition in active substances and the same pharmaceutical form as another already authorised and registered, the applicant may use the pharmaceutical, pre-clinical and a clinical hearing on the file of the authorised medicinal product provided that it has the consent of the holder.

7. Medicinal products containing active substances which fall within the composition of authorised medicinal products but which have not been combined for therapeutic purposes shall provide the results of the new clinical trials and of the studies pre-clinical relative to the combination without the need to provide the documentation for each individual active substance.

8. Given the authorisation of a medicinal product, any modification requested in connection with the medicinal product shall comply with the documentary requirements to be laid down.

9. The holder of the authorization of a medicinal product must keep the file provided to obtain it, incorporating the same data, reports or technological changes as necessary for the advances of science and standards of correct manufacturing and control. It shall also provide the periodic safety update reports as set out in the legislation in force in order to keep the safety file up to date.

10. The competent public authorities may at any time require the pharmaceutical laboratory to justify the performance of the quality checks and the number of other checks laid down in the rules in force.

Article 18. Data uniqueness.

1. Without prejudice to the right of protection of industrial and commercial property, generic medicinal products authorised in accordance with Article 17 (3) shall not be placed on the market until 10 years after the date on which they are authorised. the initial authorisation of the reference medicinal product.

This 10-year period of data exclusivity shall be extended to a maximum of 11 years if, during the first eight years of the 10-year period, the holder of the reference medicinal product's authorisation obtains an authorisation for one or more new therapeutic indications and, during the scientific evaluation prior to their authorisation, it is established that these indications will provide a significant clinical benefit in comparison with existing therapies.

2. In the event that a new indication is authorised for a well established medical substance, based on clinical trials or significant preclinical studies, a non-cumulative period of data exclusivity of one year shall be granted.

3. Where, on the basis of clinical trials or significant preclinical studies, the authorisation of medicinal product subject to medical prescription has been modified by the medicinal product not subject to medical prescription or vice versa, a period of one year of data uniqueness for the same.

Article 19. Prescription and dispensing conditions for medicinal products.

1. In the authorisation of the medicinal product, the Spanish Agency for Medicinal Products and Sanitary Products shall determine their prescribing conditions by classifying it, as appropriate, in the following categories:

a) Drug subject to medical prescription.

b) Drug not subject to medical prescription.

2. Medicinal products which are in any of the following cases shall be subject to medical prescription:

a) They may present a hazard, directly or indirectly, even under normal conditions of use, if they are used without medical control.

(b) They are used frequently, and very considerably, under abnormal conditions of use, and this may be, directly or indirectly, a health hazard.

(c) Contain substances or preparations based on these substances, the activity and/or adverse reactions of which need to be studied in more detail.

d) Be administered parenterally, except in exceptional cases, by medical prescription.

3. The Spanish Agency for Medicinal Products and Sanitary Products may establish, in medicinal products which can only be dispensed under medical prescription, the following subcategories:

(a) Dispensing drugs under renewable or non-renewable medical prescription.

b) Medicines subject to special medical prescription.

c) Medicines for dispensing under restricted medical prescription, for use reserved for certain specialized media.

The criteria will be set for your application.

4. The Spanish Agency for Medicinal Products and Sanitary Products may qualify as non-prescription medicinal products for those intended for processes or conditions which do not require a precise diagnosis and whose assessment data toxicological, clinical or use and route of administration do not require medical prescription, so that such medicinal products can be used for health care, by dispensing at the pharmacy office by a pharmacist, which shall inform, advise and instruct on their correct use.

5. The prospects and labelling of medicinal products which do not require medical prescription, in addition to those provided for in Article 15.1, shall contain those warnings which are appropriate to their nature and, in particular, to the prevention of their use. undue.

6. The Ministry of Health, Social Services and Equality shall lay down the minimum requirements, characteristics and period of validity of medical prescriptions and hospital prescriptions, as well as the special requirements for prescription and dispensing of the medicinal products of psychoactive substances and others which, by their nature, require it or for particular treatments.

7. The dispensing of medicinal products shall be in accordance with the prescribed conditions of prescription.

8. The Spanish Agency for Medicinal Products and Sanitary Products, in order to adjust the units dispensed by pharmacy offices for the duration of the treatment, may authorise the supply of specific units within six months to be counted. from the determination of the corresponding groups of medicines and/or pathologies. These units may be dispensed from the fractionation of a package of authorised and registered medicinal products, in compliance with the integrity of the primary packaging, except where, in the framework of projects or programmes approved by the The Agency shall ensure that the Agency is fully reconditioned and ensures the conditions for the preservation of the medicinal product, as well as information to the patient.

For the cases provided for in this paragraph, the Ministry of Health, Social Services and Equality shall establish the system of calculation of the selling price to the public and the corresponding marketing margins.

9. In order to ensure the rational use of medicinal products, the Spanish Agency for Medicines and Health Products will take all necessary measures to bring the contents of all the packaging of the new authorised medicinal products into line with the duration of the treatments in clinical practice. It shall also carry out annual reviews, for the same purposes, of the medicinal products already authorised, giving a semi-annual account to the Interterritorial Council of the National Health System.

Article 20. Refusal of authorization.

The authorization of a drug may be denied for the following reasons:

a) When the benefit-risk ratio is not favorable.

(b) Where the therapeutic efficacy is not sufficiently justified.

c) When the medicinal product does not have the declared qualitative and quantitative composition or lack the appropriate quality.

(d) Where the data and information contained in the documentation of the application for authorisation are incorrect or do not comply with the rules of application in this field.

Article 21. Validity of the authorization.

1. The authorisation of medicinal products shall be five years.

2. The authorisation may be renewed after five years, subject to reassessment of the benefit/risk ratio. The renewal of the authorisation shall be indefinite unless the reasons for pharmacovigilance justify its submission to a new renewal procedure.

3. The holder of an authorization shall expressly communicate to the Spanish Agency for Medicinal Products and Health Products the placing on the market for the first time of a medicinal product authorised and registered by that Agency and shall carry out an annual a marketing declaration on the terms that are regulated.

4. The authorisation of a medicinal product shall be deemed to have expired if, within three years, the holder does not proceed to the effective marketing of the medicinal product or once authorised, registered and marketed is no longer effective on the market. for three consecutive years. The foregoing shall not apply where health or health concerns are present, in which case the Spanish Agency for Medicinal Products and Sanitary Products shall maintain the validity of the authorization and may require the effective marketing of the product.

Article 22. Suspension and revocation of the authorisation.

1. The authorisation shall be temporarily suspended or definitively revoked by the Spanish Agency for Medicinal Products and Health Products in the following cases:

(a) Where the medicinal product does not have the authorised quantitative or qualitative composition or when the quality guarantees are not complied with or when the quality checks required by this law are not carried out.

b) When, based on safety data and/or efficacy, the medicinal product has an unfavourable benefit/risk ratio.

c) When the medication is not therapeutically effective.

(d) Where the data and information contained in the documentation of the application for authorisation are incorrect or do not comply with the rules of application in this field.

e) When, for any other cause, it poses a foreseeable risk to the health or safety of people or animals.

(f) In any other case where the European Medicines Agency has agreed to do so.

g) When it is not in compliance with the requirements laid down in the conditions of marketing authorisation for pharmacovigilance.

2. The Spanish Agency for Medicinal Products and Sanitary Products may, at the request of the holder of the authorisation, temporarily suspend or revoke the authorisation of a medicinal product, on grounds of technological, scientific or any other provided and provided that the decision does not lead to therapeutic lacuna in the pharmaceutical provision of the National Health System and does not collide with the criteria laid down in this law for the inclusion of medicinal products in that provision.

Article 23. Amendments to the authorisation for reasons of general interest.

The Spanish Agency for Medicinal Products and Sanitary Products may amend, in a justified manner and by notifying the holder of the marketing authorisation, the authorisation of medicinal products which require it for reasons of public interest or defence of the health or safety of persons. This shall, without prejudice to the obligation of the marketing authorisation holder to ensure that the information in its products is up to date on the basis of the latest scientific knowledge, including the conclusions of the evaluations and the recommendations published on the European medicines web portal and on the website of the Spanish Agency for Medicines and Health Products.

Article 24. Product availability guarantees in specific situations and special authorizations.

1. In exceptional circumstances, the Spanish Agency for Medicinal Products and Sanitary Products may grant an authorisation subject to the obligation on the part of the applicant to comply with certain conditions which may be reviewed annually. Those conditions shall, in particular, concern the safety of the medicinal product, the information to the competent authorities of any incident relating to its use and the measures to be taken. The criteria for the granting of such authorisations shall be laid down.

2. The Spanish Agency for Medicinal Products and Sanitary Products may, on its own initiative or at the request of the autonomous communities concerned, for objective and duly substantiated health reasons, subject to special reservations the authorization of medicinal products. they so require by their nature or characteristics, as well as their general conditions of prescription and dispensing.

3. The prescription and application of unauthorised medicinal products to patients not included in a clinical trial in order to treat as a compassionate use special needs for the treatment of clinical situations of individual patients will be regulated. In full compliance with the provisions of the existing legislation on patient autonomy and on the rights and obligations of clinical information and documentation.

The person holding the Ministry of Health, Social Services and Equality shall lay down the conditions for the prescription of authorised medicinal products when used under conditions other than those authorised, which in any case shall be exceptional.

4. The Spanish Agency for Medicinal Products and Sanitary Products may authorise the importation of medicinal products not authorised in Spain provided that they are lawfully marketed in other States, where such importation is essential for the prevention, diagnosis or treatment of specific pathologies because there is no suitable alternative in Spain authorised for this particular indication or for situations of supply that justify it.

5. The Spanish Agency for Medicinal Products and Sanitary Products may temporarily authorise the distribution of unauthorised medicinal products in response to the suspected or confirmed spread of a pathogenic or chemical agent, toxin or capable nuclear radiation. of causing damage. In such circumstances, if the use of medicinal products in unauthorised indications or unauthorised medicinal products, authorisation holders and other professionals involved in the use of medicinal products have been recommended or imposed by the competent authority, process would be exempt from civil or administrative liability for all consequences arising from the use of the medicinal product, except for damage caused by defective products.

6. The Spanish Agency for Medicinal Products and Sanitary Products shall exceptionally authorise the production and distribution of free samples under the conditions which they regulate. In any case, free samples of medicinal products of psychoactive substances causing dependence and of those determined by the Spanish Agency for Medicines and Health Products shall not be authorised.

7. The Spanish Agency for Medicinal Products and Sanitary Products may establish special authorisation procedures for medicinal products which, in accordance with an express resolution of the same, are deemed necessary to meet special requirements, provided that they are intended for use by an individual patient on prescription from an accredited practitioner and under his direct responsibility.

CHAPTER III

Of the guarantees payable to the industrially manufactured veterinary medicinal products and the conditions of prescription and dispensing of the same

Article 25. Authorization and registration.

1. No veterinary medicinal product manufactured industrially may be placed on the market without the prior authorization of the Spanish Agency for Medicines and Health Products and registration in the Register of Medicinal Products or without obtaining the authorisation in accordance with the provisions of the European rules laying down the Community procedures for the authorisation and control of medicinal products for human and veterinary use and which regulate the European Medicines Agency. For the purposes of this Article and, in general, in this chapter, the Spanish Agency for Medicines and Health Products will act in accordance with the criteria set out by the Ministry of Agriculture, Food and the Environment, and to animal health regulations.

2. Where a veterinary medicinal product has obtained an authorisation in accordance with the above paragraph, any dosage, pharmaceutical form, route of administration and additional presentations, as well as any other modifications and extensions to the the authorisation file to be introduced shall be the subject of authorisation or notification as provided for in the rules governing the procedure for the authorisation, registration and pharmacovigilance of veterinary medicinal products manufactured industrially. All such modifications shall be considered as belonging to the same global marketing authorisation, in particular for the purposes of the application of the data exclusivity periods.

3. Any modification, transmission and termination of the authorisations of veterinary medicinal products shall be recorded in the Register of Medicinal Products which, for these purposes, shall have the same status as the registration.

4. The Spanish Agency for Medicinal Products and Sanitary Products shall proceed on its own initiative to the incorporation into the Register of Medicinal Products of the authorisations granted by the European Commission in accordance with Regulation (EC) No 726 /2004/EC.

Article 26. Guarantees required for the authorisation of medicinal products.

1. The Spanish Agency for Medicinal Products and Sanitary Products shall authorise a veterinary medicinal product if it satisfies the following conditions:

a) Reach the minimum quality requirements that are set.

b) Be sure.

c) Be effective in the therapeutic indications for which it is offered.

d) Be correctly identified.

e) Provide accurate information.

2. The assessment of the positive therapeutic effects of the medicinal product shall be assessed in relation to any risk related to the quality, safety and efficacy of the medicinal product for animal health or public health, understood as benefit/risk. This assessment will be adapted to the specific needs in the case of medicinal products intended for terrarium animals, household birds, aquarium fish, small rodents and others that do not require prescription. veterinary.

3. The provisions of this Article shall also apply to changes in the authorisation of the medicinal product.

Article 27. Quality assurance.

1. Any medicinal product must have its qualitative and quantitative composition perfectly established. Alternatively, in the case of substances such as biological substances where this is not possible, their preparation procedures should be reproducible.

2. The Ministry of Health, Social Services and Equality, in coordination with the Ministry of Agriculture, Food and the Environment, shall establish the type of controls required from the marketing authorisation holder and the manufacturer to ensure the quality of the raw materials, intermediate products, manufacturing process and final product for the purposes of the authorisation and registration, while maintaining such controls for the duration of production and/or marketing of the medicinal product. Quality control procedures shall be modified in accordance with the progress of the technique.

3. The competent health authorities shall carry out periodic checks on the quality of the medicinal products existing on the market, raw materials and intermediate products, as well as the packaging material and the conditions of conservation, transport and sales.

Article 28. Security guarantees.

1. Medicinal products, medicinal substances and the excipients which make up those medicinal products shall be the subject of toxicological and clinical studies to ensure their safety under normal conditions of use and which shall be in relation to the intended duration of the treatment.

2. The studies shall include studies of acute and chronic toxicity, teratogenic tests, embryotoxicity, fertility, mutagenesis and, where appropriate, carcinogenesis and, in general, those tests which are considered necessary for the correct use of assessment of the safety and tolerance of a medicinal product under normal conditions of use and depending on the duration of the treatment. In any case, the rules on the protection of animals used for scientific purposes shall be complied with.

3. Veterinary medicinal products shall be the subject of further studies and tests to ensure their safety, which shall be taken into account:

(a) That when food producing animals intended for human consumption are given to animals, the appropriate waiting time to eliminate the risks for persons arising from residues or metabolites of food is to be known. those.

(b) The impact on the persons handling them, mainly for products intended for mixing with feed.

c) Influences on the environment, when they can result in residual action through waste products.

d) Dealing with biological products and vaccines in particular, the epizootic effects.

4. Without prejudice to their own responsibility, all health authorities and professionals, as well as pharmaceutical laboratories and distribution entities, are required to collaborate diligently in the knowledge of product safety. In addition, healthcare professionals, pharmaceutical laboratories and distribution entities are obliged to communicate to the health authorities the anomalies of the health authorities, in accordance with the provisions of Chapter VI of this Regulation. title.

Article 29. Guarantees of effectiveness.

1. The efficacy of veterinary medicinal products shall be established in a manner appropriate to each of the species and indications for which they are intended by means of the prior conduct of clinical trials and pre-clinical studies controlled by sufficiently qualified persons.

2. Such studies shall reproduce the effects of the different doses requested for the substance in such a way as to regulate and include, in addition, one or more control groups treated or not with a reference product.

Article 30. Identification guarantees.

1. Each active substance for veterinary use shall use the corresponding Spanish official name (DOE) in accordance with Article 14.

2. A veterinary medicinal product may be designated with a mark or a Spanish official name of active substance and, failing that, with the international name or, if it does not exist, with the usual common name or scientific name. of that substance. The cases in which a generic medicinal product may be designated with a trade name or a trade mark may be regulated. The name of the medicinal product, where it is a trade mark or a trade name, shall not be confused with a Spanish official name of active substance or an international common name or mislead on the property therapeutic or the nature of the medicinal product.

3. The Spanish Agency for Medicinal Products and Sanitary Products shall establish a National Code of Veterinary Medicinal Products of general application which facilitates its early identification and may also require that its numbers or keys appear on the packaging, labelling and packaging of veterinary medicinal products.

Article 31. Information guarantees.

1. The Ministries of Agriculture, Food and the Environment, Health, Social Services and Equality shall regulate the aspects relating to the guarantees of information and, in particular, the characteristics, extent, details and places where it is to be figure. In any case, the holder shall provide sufficient written information on the identification, indications and precautions to be taken in his employment for the preparation of this information on the veterinary medicinal product. This information shall be submitted, at least, in the official Spanish language of the State and the technical information sheet, package leaflet and the label shall be drawn up.

The texts and other characteristics of the technical information sheet, the package leaflet and the labelling form part of the authorisation of the veterinary medicinal products and must be approved by the Spanish Medicines Agency and Sanitary Products. Their amendments shall also require prior authorisation or notification, as appropriate.

2. The technical information sheet shall summarise the essential scientific information on the veterinary medicinal product concerned. The Spanish Agency for Medicinal Products and Sanitary Products shall approve the technical information sheet containing sufficient information on the identification of the veterinary medicinal product and its holder, the information required for a therapeutic and correct pharmaceutical care, according to the studies that support your authorization.

The Spanish Agency for Medicinal Products and Health Products will make the technical information available to the autonomous communities, to the professional associations and to the veterinary and pharmaceutical organizations in the exercise. The holder of the authorization shall be obliged to make the updated technical information available to the professionals in all their promotional activities and information in the terms laid down in the regulations, as well as when he/she is requested.

3. The package leaflet shall provide sufficient information on the identification of the veterinary medicinal product and its holder and instructions for administration, use and storage, as well as on adverse effects, interactions, contraindications, time-waiting, if appropriate, and other data to be determined in a regulated manner in order to promote the correct use and enforcement of the prescribed treatment, as well as the measures to be taken in case of intoxication. In addition, the prospectus should not contain terms of a technical nature in order to ensure its easy reading and understanding.

4. The particulars of the veterinary medicinal product, the holder of the authorization, the route of administration, the quantity contained, the number of the manufacturing lot, the date of expiry, the storage precautions, the conditions of storage, the packaging and the packaging shall be shown on the packaging and packaging. dispensing, waiting time, if applicable, and other data to be determined.

When dispensing a medicinal product, the pharmacy offices, the authorized retail establishments and the pharmacy services of the livestock organizations or groups shall issue a receipt stating the name of the medicinal product and its selling price to the public.

5. In order to ensure access to information for blind and visually impaired persons, the provisions necessary for the packaging of medicinal products intended for pet animals to be included shall be developed. printed in the alphabet braille the data necessary for its correct identification, as well as the holder of the authorization to ensure that, upon request of the associations concerned, the package leaflet is available in appropriate formats for the blind or partially sighted persons.

6. Regulations shall lay down the requirements necessary to facilitate the application and development of a system for the collection of unused or expired veterinary medicinal products.

Article 32. Authorisation procedure and amendments thereto. Requirements and guarantees of transparency.

1. In accordance with the provisions of this law, the Government shall regulate the procedure for obtaining authorization and registration in the Register of Medicinal Products, in accordance with the procedures and deadlines established by the European Union under the Community harmonisation. The Government shall also regulate, in accordance with Community rules, the procedure for the notification and authorisation of any modifications to the initial authorisation.

2. The Spanish Agency for Medicines and Health Products may require the applicant to provide supporting documentation, studies, data or information, and the specific rules for the development of this law apply and, in its defect, the regulatory rules of the common administrative procedure.

3. In the procedure for the evaluation of veterinary medicinal products, the Spanish Agency for Medicinal Products and Sanitary Products, in coordination with the Ministry of Agriculture, Food and the Environment, will have the effect of issuing the appropriate reports, with committees or advisory bodies incorporating qualified experts from the autonomous communities and from the scientific and professional world.

4. In the authorisation procedure, the medicinal product, its raw materials, intermediate products and other components may be submitted for examination by the official control laboratories of the Spanish Agency for Medicinal Products and Health Products or, in its case, of another national laboratory accredited for that purpose by the Agency itself or an official Community or third country control laboratory.

5. The authorisations of veterinary medicinal products, their modifications, suspensions and revocations, when all of them are firm, as well as the summary of the product characteristics, shall be publicly accessible. The reasoned assessment report shall also be publicly accessible, subject to the deletion of any commercial information of a confidential nature. Without prejudice to the foregoing, the content of the dossiers for the authorisation of veterinary medicinal products shall be of a confidential nature. However, the inspectors for the development of their duties may have access to all the information they require.

Article 33. Authorization file.

1. The dossier for the authorisation of a veterinary medicinal product shall consist of all the documentation relating to administrative information, summaries of experts, chemical, pharmaceutical and biological information for veterinary medicinal products containing chemical and/or biological active substances, safety tests and studies of residues and pre-clinical and clinical trials, and any other that is determined by regulation. The applicant or holder of an authorisation shall be responsible for the accuracy of the documents and data presented.

2. The application for authorization of veterinary medicinal products shall include, among the identification data, the complete and accurate qualitative and quantitative composition, including not only medicinal substances, but also all excipients and the solvents, even if the latter disappear in the manufacturing process.

3. Without prejudice to the right relating to the protection of industrial and commercial property, the applicant shall have no obligation to provide the results of the safety and residue studies tests and the pre-clinical and clinical trials. established if it can demonstrate that the medicinal product is generic of a reference veterinary medicinal product which has been or has been authorised and registered for at least eight years in any Member State of the European Union or by the European Union, even where the reference medicinal product was not authorised in Spain.

4. Where a biological veterinary medicinal product which is similar to a reference biological product does not meet the conditions of the definition of a generic medicinal product, due in particular to differences in the raw materials or differences in the process of manufacture of the biological medicinal product and the reference biological medicinal product, the results of appropriate pre-clinical or clinical trials relating to those conditions and other established requirements shall be provided regulentarily.

5. The applicant may replace the results of the safety tests and the residue studies and the pre-clinical or clinical trials with an appropriate bibliographic-scientific documentation if it can demonstrate that the active substance of the Veterinary medicinal product has had a well established veterinary use, at least for 10 years, within the European Union and has recognised efficacy, as well as an acceptable level of safety.

6. In the case of a veterinary medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as another authorised, the applicant may use the pharmaceutical, safety, residue, pre-clinical and clinical study on the dossier of the authorised veterinary medicinal product provided that it has the consent of the holder.

7. Veterinary medicinal products containing active substances which fall within the composition of authorised veterinary medicinal products but which have not been combined for therapeutic purposes shall provide the results of the safety tests and residue studies, if necessary, and the results of new clinical and pre-clinical trials relating to the combination without the need to provide the documentation relating to each individual active substance.

8. The authorisation of a veterinary medicinal product shall be granted any modification requested in connection with the veterinary medicinal product, and shall be duly documented as provided for in regulation.

9. The holder of the authorization of a veterinary medicinal product shall keep the dossier provided for that veterinary medicinal product up to date, incorporating into the same data, reports or technological changes, the advances of science and rules of correct manufacturing and control. It shall also provide the periodic safety update reports in order to keep the safety file up to date.

10. The Spanish Agency for Medicinal Products and Sanitary Products or the Autonomous Communities may at any time require the pharmaceutical laboratory to justify carrying out the quality checks and the number of others to be established. in the authorization and registration of that.

Article 34. Data uniqueness.

1. Without prejudice to the right of protection of industrial and commercial property, generic veterinary medicinal products authorised in accordance with Article 3 (3) shall not be placed on the market until 10 years after the date of entry into force of this Regulation. from the date of the initial authorisation of the reference medicinal product. However, the dossiers for veterinary medicinal products intended for fish, bees and other species to be determined in the field of the European Union shall have a period of data exclusivity of thirteen years.

For veterinary medicinal products intended for food-producing species, the period of 10 years referred to in the preceding paragraph may be extended to a maximum of 13 years in accordance with the conditions laid down in the rules are set out.

2. In the event that a well established veterinary use substance is granted, on the basis of new residue studies and new clinical trials, an authorisation for another food producing species, that species shall be granted a period of time. Three-year data exclusivity.

Article 35. Grounds for refusal, suspension or revocation of the authorisation.

1. The grounds for refusal, suspension or revocation of the authorisation of a veterinary medicinal product shall be:

(a) The benefit-risk ratio of the veterinary medicinal product is not favourable under the authorised conditions of employment. When referring to veterinary medicinal products for zootechnical use, particular account shall be taken of the health and welfare benefits of the animals, as well as of safety for the consumer.

(b) The veterinary medicinal product has no therapeutic effect or is insufficiently justified in respect of the animal species to be treated.

(c) The veterinary medicinal product does not have the declared qualitative or quantitative composition.

(d) that the indicated withdrawal period is insufficient to ensure that food products from the treated animal do not contain residues which may present a danger to the health of the consumer, or are insufficiently justified.

e) The veterinary medicinal product to be offered for sale for unauthorised use.

(f) Failure to comply with the obligations laid down in regulation.

(g) Any other scenario in which the European Medicines Agency has agreed to do so.

2. The suspension and revocation referred to in the preceding paragraph shall, in accordance with the provisions laid down therein, lead to the corresponding inspection and control measures carried out by the General Administration of the State, where appropriate, or by Autonomous communities.

3. A decision to refuse, suspend or revoke the authorisation of a veterinary medicinal product shall be reasoned and shall be adopted on the basis of a report from the competent committee of the Spanish Agency for Medicinal Products and Health Products evaluation of veterinary medicinal products, in which the Ministry of Agriculture, Food and the Environment must be represented.

Article 36. Validity of the authorization.

1. The authorisation of veterinary medicinal products shall be five years.

2. The authorisation may be renewed after five years, subject to reassessment of the benefit/risk ratio. The renewal of the authorisation shall be indefinite unless the reasons for pharmacovigilance justify its submission to a new renewal procedure.

3. The holder of an authorization shall, in an express manner, communicate to the Spanish Agency for Medicinal Products and Health Products the placing on the market for the first time of an authorised medicinal product and shall carry out an annual marketing declaration in the terms that you regulate are set.

4. The authorisation of a veterinary medicinal product shall be deemed to have expired if, within three years, the holder does not proceed to the effective marketing of the veterinary medicinal product or once authorised, registered and marketed is no longer effective in the market for three consecutive years. The foregoing shall not apply where health or health concerns or exceptional circumstances are present; in such a case, the Spanish Agency for Medicinal Products and Sanitary Products shall maintain the validity of the authorization and may require the effective marketing of the product.

Article 37. Prescription of veterinary medicinal products.

1. In order to protect human health and animal health, veterinary prescription shall be required to provide the public with the following veterinary medicinal products:

(a) Medicinal products for which veterinary surgeons are required to take special precautions in order to avoid unnecessary risks to the species to which they are intended, to the person administering such medicinal products to animals and the environment.

(b) Those intended for pathological treatments or processes that require prior accurate diagnosis or whose use may result in consequences that hinder or interfere with subsequent diagnostic or therapeutic actions.

(c) Medicinal products for psychoactive substances whose supply or use is subject to restrictions resulting from the application of the relevant United Nations conventions against illicit trafficking in narcotic and psychotropic substances or those resulting from Community legislation.

(d) Veterinary medicinal products intended for food-producing animals. However, the Ministry of Health, Social Services and Equality, after consulting the Ministry of Agriculture, Food and the Environment, may derogate from this requirement in accordance with the decisions taken by the European Commission. in this subject.

e) The medicinal products used in the exceptional prescription for therapeutic vacuum, including official preparations, masterways and self-vaccines.

f) The immunological.

2. In addition, a prescription shall be required for all new veterinary medicinal products containing an active substance for use in veterinary medicinal products for less than five years.

3. The system of exceptional requirements shall be laid down.

4. Without prejudice to the assumptions provided for in the current legislation, the administration, directly by or under its responsibility, shall be required of all veterinary medicinal products provided for in the authorization of the (c) and (f) of paragraph 1 shall be placed on the market

referred to in paragraph 1.

5. The veterinary prescription shall be valid throughout the national territory and shall be published in the official Spanish language of the State and in the respective co-official languages in the autonomous communities which have it. The data to be recorded in the veterinary prescription shall be established.

Article 38. Distribution and dispensing of veterinary medicinal products.

1. The Government shall develop the basic rules on the distribution and supply of veterinary medicinal products.

2. The dispensing of medicinal products to the public shall be carried out exclusively by:

(a) The legally established pharmacy offices, which in addition will be the only ones authorized for the elaboration and dispensing of official formulas and formal preparations.

(b) Authorized retail establishments, provided that they have a pharmaceutical service responsible for the custody, preservation and dispensing of these medicinal products.

(c) Authorized livestock entities or groups with a pharmaceutical service responsible for the custody, conservation and dispensing of these medicinal products for the exclusive use of their members.

The professional performance of the pharmacist shall be regulated in each of the establishments described above in paragraphs (b) and (c) as a condition and requirement to ensure effective control in the dispensing of veterinary medicinal products to the public.

However, medicinal products intended for dogs, cats, terrarium animals, household birds, aquarium fish and small rodents which do not require veterinary prescription may be distributed and sold in other countries. establishments, in accordance with the prescribed terms.

3. For reasons of urgency and remoteness of pharmacy offices, veterinary medicinal products may be used under the conditions to be determined.

4. The arrangements for the acquisition, distribution and supply of veterinary medicinal products by authorized livestock groups or groups with pharmaceutical and veterinary services for use shall be established. exclusive of its members.

The system whereby the animal feed and livestock farming industries may be directly acquired may also be established directly by the authorised medicated premixtures intended for the production of medicated feed.

5. Public administrations may, in the exercise of their powers, acquire veterinary medicinal products, in particular vaccines, which are accurate, directly from pharmaceutical laboratories or from any distribution centre. authorized.

Article 39. Guarantees of availability of veterinary medicinal products in specific situations and special authorisations.

1. In exceptional circumstances, the Spanish Agency for Medicinal Products and Sanitary Products may grant an authorisation subject to the obligation on the part of the applicant to comply with certain conditions which may be reviewed annually. Those conditions shall, in particular, concern the safety of the medicinal product, the information to the competent authorities of any incident relating to its use and the measures to be taken. The criteria for obtaining these authorisations will be established.

2. Without prejudice to the system of exceptional requirements, the Ministry of Health, Social Services and Equality, in agreement with the Ministry of Agriculture, Food and the Environment, shall, by way of exception, regulate the use of medicinal products by veterinary medicinal products under conditions other than those authorised, in order to ensure animal welfare and to avoid unnecessary suffering to animals or for reasons of animal health. This regulation should in any case be established in accordance with the provisions of the animal health legislation.

3. In the case of serious epizootic diseases, the Spanish Agency for Medicinal Products and Sanitary Products, upon request and a mandatory report from the Ministry of Agriculture, Food and the Environment, may provisionally permit the use of medicinal products. immunological veterinary medicinal products without authorisation, if the appropriate medicinal product does not exist, in advance of their conditions of use to the European Commission.

Article 40. Clinical trials with veterinary medicinal products.

1. For the purposes of this law, it is understood by clinical trial in animals with an investigational medicinal product, to any research carried out through its administration or application to the species of destination, or to a particular category of the same, to the intended to be used for the future treatment, to be confirmed when the pharmacodynamic and/or pharmacokinetic effects are deemed appropriate and/or to establish efficacy for a therapeutic indication and/or to know the profile of their adverse reactions and/or establish security and/or tolerance under normal conditions of use.

2. Clinical trials in animals with investigational medicinal products shall be subject to authorisation by the Spanish Agency for Medicinal Products and Sanitary Products, in accordance with the regulatory procedure laid down. In addition, the applicable rules for the protection of animals used for experimental and other scientific purposes shall be complied with.

Article 41. Spanish Pharmacovigilance System for Veterinary Medicinal Products.

1. The Spanish Pharmacovigilance System for Veterinary Medicinal Products is intended to identify, quantify, evaluate and prevent the risks of the use of veterinary medicinal products and to monitor the possible adverse effects of the use of veterinary medicinal products. These in animals, people or the environment, as well as the presumed lack of efficacy and the detection of inadequate waiting times.

2. The Spanish pharmacovigilance system for veterinary medicinal products which, coordinated by the Spanish Agency for Medicinal Products and Health Products and as provided for in Article 57, shall be integrated into the Spanish system shall be regulated. Health administrations to collect and develop information on adverse reactions to veterinary medicinal products.

3. Pharmaceutical laboratories, veterinarians, pharmacists and other healthcare professionals have a duty to communicate to the Spanish Agency for Medicines and Health Products, in a manner that is determined by law. suspected adverse reactions of which they are aware and may have been caused by veterinary medicinal products.

CHAPTER IV

Of the health guarantees of the official formulas and official preparations

Article 42. Requirements of the master formulas.

1. The masterways will be prepared with substances of action and indication legally recognized in Spain, in accordance with article 44.1 and according to the guidelines of the National Form.

2. The master formulas shall be drawn up in the offices of pharmacy and legally established pharmaceutical services which have the necessary means for their preparation in accordance with the requirements laid down in the National Form.

However, pharmacy offices and pharmaceutical services which do not have the necessary means, exceptionally and without prejudice to the provisions of Article 66.2, may entrust an institution with those provided for in this Article. the law, authorized by the competent health administration, the performance of one or more stages of the elaboration and/or control of master formulas.

3. In the preparation of masterways, the rules of correct elaboration and quality control of the official formulas and official preparations will be observed.

4. The master formulae intended for animals shall be prescribed by a veterinarian and shall be used for an individual animal or for a small number of animals on a particular holding which are under the direct care of the animal. optional. They will be prepared by a pharmacist, or at their address, in their pharmacy office.

5. The master formulae shall be accompanied by the name of the pharmacist who prepares them and of sufficient information to ensure proper identification and preservation, as well as their safe use.

6. The masterful formulation of substances or medicinal products not authorised in Spain shall comply with the arrangements provided for in Article 24.

Article 43. Requirements for official preparations.

1. Official preparations shall comply with the following conditions:

a) Be listed and described in the National Form.

b) Meet the rules of the Spanish Royal Pharmacopoeia.

c) Be prepared and guaranteed by a pharmacist in the pharmacy or pharmacy department who disfigured them.

(d) To be presented and dispensed necessarily under active principle or, failing that, under a common or scientific name or expressed in the national form and, in no case, under commercial trade mark.

e) To be accompanied by the name of the pharmacist who prepares them and of sufficient information to ensure proper identification and preservation, as well as their safe use.

2. Exceptionally, and without prejudice to the provisions of Article 66.2, pharmacy offices and pharmaceutical services which do not have the necessary means may entrust a body legally authorized for that purpose by the Administration. competent health care shall be carried out at one or more stages of the preparation and/or control of, exclusively, those formal preparations which are subject to an optional prescription.

3. Official preparations for animals shall be made in pharmacy offices in accordance with the instructions of a form and shall be delivered directly to the end user.

Article 44. National Form.

1. The National Form shall contain the standard forms and the official preparations recognised as medicinal products, their categories, indications and raw materials involved in their composition or preparation, as well as the rules of correct preparation and control of those.

2. Pharmacy offices and pharmaceutical services must ensure that they have access to the documentation for the National Form.

3. The advertising of formal and formal formulae is expressly prohibited.

CHAPTER V

Of the health guarantees of special medicines

Article 45. Vaccines and other biological medicinal products.

1. Vaccines and biological products which may be used as medicinal products shall be subject to the arrangements of such medicinal products with the particularities provided for in this law or which are regulated in accordance with their nature and characteristics of their application.

2. The individual preparation of vaccines and allergens for a single patient, which may only be carried out under the conditions and establishments meeting the particularities, is exempted from the provisions of the preceding paragraph. rules are set out.

3. In the case of biological products, where necessary in the interest of public health, the Spanish Agency for Medicinal Products and Sanitary Products may subject to prior authorization each batch of finished product manufacture and condition the (a) the marketing of It may also subject to prior authorization the materials of origin, intermediate products and bulk products and make their use in the manufacture conditional on their conformity. Such checks shall be deemed to have been carried out when they are documented in the country of origin, with the same requirements as those laid down in this law and provided that the original conditions of the product.

Article 46. Medicinal products of human origin.

1. Blood, plasma and other substances of human origin (fluids, glands, excretions, secretions, tissues and any other substances), as well as their related derivatives, when used for the purpose therapeutic, be considered medicinal products and be subject to the regime provided for in this law, with the particularities to be established regulatively according to their nature and characteristics.

2. The blood, plasma and its derivatives, as well as the other substances of human origin referred to in paragraph 1 and their derivatives, must be obtained in approved centres and under the supervision and supervision of these centres, any case of donors identified through the relevant donor register. These approved centres shall take the necessary control, surveillance and traceability measures to prevent the transmission of infectious diseases.

3. Importation and authorization as medicinal products for blood and plasma derivatives may be refused or revoked where such medicinal products do not originate from altruistic donations made in blood banks or plasmapheresis centres located in the Member States of the European Union which meet due guarantees.

4. The importation and authorisation as medicinal products of the other substances of human origin referred to in paragraph 1, as well as their corresponding derivatives, shall be refused or revoked where it does not come from donors identified by the registration or where it has not been obtained in approved centres which meet the precise control, surveillance and traceability measures required in paragraph 2.

5. Authorisation as medicinal products for blood and plasma derivatives may be conditional upon the submission by the applicant of documentation stating that the price of the medicinal product does not include an illegitimate benefit on the blood altruistic form.

Healthcare Administrations will promote altruistic blood donations as well as the development of the production and use of blood products from these donations.

Article 47. Advanced therapy medications.

1. 'Gene therapy medicinal product' means the product obtained by a set of manufacturing processes intended to transfer, in vivo or ex vivo, a prophylactic, diagnostic or therapeutic gene, such as a fragment of nucleic acid, to human/animal cells and their subsequent expression in vivo. Genetic transfer involves a system of expression contained in a distribution system known as vector, which may be of viral or non-viral origin. The vector may also be included in a human or animal cell.

2. 'somatic cell therapy medicinal product' means the use in humans of live somatic cells, both autologous, from the patient itself, as allogeneic, from another human being, or xenogenic, from animals, whose biological characteristics have been substantially altered as a result of their manipulation to obtain a therapeutic, diagnostic or preventive effect by metabolic, pharmacological and immunological means. Such manipulation includes the expansion or activation of autologous ex vivo cell populations, such as adoptive immunotherapy, and the use of allogeneic and xenogenic cells associated with healthcare products used ex vivo or in vivo, Such as microcapsules, matrices and intrinsic, biodegradable or non-biodegradable scaffolds.

3. The general criteria and requirements of this law, as well as the European legislation on the required guarantees and conditions of authorisation, shall apply to the advanced therapy medicinal products referred to in this Article, provided that manufactures industrially.

The government will regulate the application of this law to advanced therapy medicinal products when, even in them, the characteristics and conditions laid down in the definitions of " drug gene therapy "or" somatic cell therapy drug ", have not been manufactured industrially.

Article 48. Radiopharmaceuticals.

1. For the purposes of this law:

(a) "Radiopharmaceutical" means any product which, when prepared for use for therapeutic or diagnostic purposes, contains one or more radionuclides (radioactive isotopes).

b) "Generator": Any system incorporating a radionuclide (radionuclide parent) that in its disintegration originates another radionuclide (radionuclide son) to be used as an integral part of a radiopharmaceutical.

(c) "Reactive equipment" means any industrial preparation that must be combined with the radionuclide to obtain the final radiopharmaceutical.

d) "Precursor": All industrially produced radionuclide for the radioactive marking of other substances prior to administration.

2. Without prejudice to any other obligations arising from a legal or regulatory provision, industrial manufacturing and the authorisation and registration of generators, reactive equipment, precursors and radiopharmaceuticals shall require prior authorisation. of the Spanish Agency for Medicines and Health Products, granted in accordance with the general principles of this law and according to the requirements and procedures that are regulated.

3. The authorization provided for in the preceding paragraph shall not be required for the extemporaneous preparation of a radiopharmaceutical, in an authorized radio unit, under the supervision and control of an optional radio-pharmacy specialist, for his/her application in a legally empowered institution or institution for this purpose, if it is carried out exclusively from generators, reactive equipment and authorised precursors and in accordance with the manufacturer's instructions.

4. The authorisation provided for in paragraph 2 shall not be required for the preparation of autologous samples where radionuclides are involved, as well as the extraction of individual doses of radiopharmaceuticals ready for use in a radiopharmaceutical unit authorised, under the supervision and control of an optional radio specialist, for the purpose of applying them to a legally empowered institution or institution.

5. The authorisation provided for in paragraph 2 may not be required for the preparation of PET (positron emission tomography) radiopharmaceuticals in an authorised radio unit under the supervision and control of an optional specialist in radio-safety, provided that it is carried out under the conditions and with the requirements laid down in regulation.

6. The provisions of this law shall be without prejudice to the provisions of the legislation on the protection against radiation of persons undergoing medical examinations or treatment or on the protection of public health and workers.

Article 49. Drugs with psychoactive substances with addictive potential.

1. The psychoactive substances included in the lists annexed to the 1961 Single Convention on Narcotic Drugs and to the 1971 Convention on Psychotropic Substances, as well as the medicinal products containing them, shall be governed by this law and by its rules specifies.

2. Those substances shall be subject to restrictions resulting from obligations arising from the United Nations in the fight against illicit trafficking in narcotic and psychotropic substances.

Article 50. Homeopathic medicines.

1. Homoeopathic medicinal product, for human or veterinary use, is considered to be obtained from substances called homeopathic strains in accordance with a homeopathic manufacturing process described in the European Pharmacopoeia or in the Royal Pharmacopoeia Spain or, failing that, in a pharmacopoeia used officially in a Member State of the European Union. A homeopathic medicinal product may contain several active substances.

2. The requirements for the authorisation of homeopathic medicinal products shall be laid down in accordance with their special conditions. In particular, a simplified procedure shall be established for products whose quality and safety guarantees permit.

3. The Spanish Agency for Medicinal Products and Sanitary Products may authorise the placing on the market and distribution of homeopathic preparations containing a component of the so-called 'nosodes' provided that the holder of the product sufficient, that the benefit-risk ratio of such preparations is favourable. For this purpose, "nosodes" shall mean pathological products of human or animal origin as well as pathogenic agents or their metabolic products and the breakdown products of organs of human or animal origin.

4. The Ministry of Health, Social Services and Equality shall establish a national code to facilitate their early identification and also require that their numbers or keys appear on the packaging, labelling and packaging of homeopathic medicinal products with the the same criteria as for other medicinal products.

Article 51. Medicinal plant medicines.

1. Plants and mixtures thereof, and preparations obtained from plants in the form of extracts, lyophilisates, distillates, tinctures, co-foundations or any other galenic preparation which is presented with therapeutic, diagnostic or preventive use follow the rules of the rules of procedure, formal preparations or industrial medicinal products, as appropriate and with the specific features which they regulate.

2. The Ministry of Health, Social Services and Equality shall establish a list of plants for which the sale to the public shall be restricted or prohibited by reason of their toxicity.

3. Plants, traditionally regarded as medicinal products, may be sold freely to the public and offered without reference to therapeutic, diagnostic or preventive properties, and their street sale is prohibited.

Article 52. Medicinal gases.

1. Medicinal gases are considered medicinal products and are subject to the regime provided for in this law, with the particularities that they regulate.

2. Without prejudice to Article 3.6, the operators, manufacturers, importers and the marketing of liquefied medicinal gases may supply them, as determined by the competent health authorities, to the centres of health care, social care for patients with home-based respiratory therapy, as well as legally authorised veterinary clinical establishments. For such purposes, liquid oxygen, liquid nitrogen and liquid nitrogen protoxide, as well as any other which, with similar characteristics and use, may be manufactured in the future, shall be understood as liquefied medicinal gases.

CHAPTER VI

From the guarantees of follow-up to the benefit/risk relationship in the drugs

Article 53. Pharmacovigilance and obligation to declare.

1. Pharmacovigilance is the activity of public health that aims to identify, quantify, evaluate and prevent the risks of the use of the drugs once marketed, thus allowing the monitoring of possible adverse effects of the medicinal products.

2. Healthcare professionals have an obligation to communicate promptly to the competent authorities in the pharmacovigilance area of each Autonomous Community the suspected adverse reactions of which they are aware and which may have have been caused by medication.

3. The autonomous communities will transfer the information received to the Spanish Agency for Medicines and Health Products.

4. The authorisation holders are also required to inform the competent health authorities of pharmacovigilance of the suspected adverse reactions to which they are aware and which may have been caused by the medicinal products they manufacture or on the market, in accordance with the European guidelines on Good Pharmacovigilance Practice. They shall also be required to update the product safety information on a permanent basis, to implement the pharmacovigilance plans and risk management programmes and to carry out a continuous assessment of the relationship. benefit/risk of the medicinal product, in accordance with national and European guidelines in this field. Where health authorities consider that such information on safety is of relevance to public health, they shall ensure public access to it.

Article 54. Spanish Pharmacovigilance System.

1. The Spanish Pharmacovigilance System, which is coordinated by the Spanish Agency for Medicines and Health Products, integrates the activities carried out on a permanent and continuous basis by the health authorities to collect, prepare and, where appropriate, processing all useful information for the supervision of medicinal products, and in particular information on adverse drug reactions, as well as for the performance of any studies considered necessary to assess the safety of medicinal products. medicines.

2. The Spanish Agency for Medicines and Health Products will evaluate the information received from the Spanish Pharmacovigilance System as well as other sources of information. The data for adverse reactions detected in Spain shall be integrated into the European and international pharmacovigilance networks, of which Spain is a party, with the guarantee of protection of the personal data required by the regulations. in effect.

3. All healthcare professionals are required to collaborate in the Spanish Pharmacovigilance System.

4. The health authorities may suspend those pharmacovigilance programmes where serious defects are found in the procedures for obtaining data and processing the information obtained. Such suspension shall require the prior approval of the competent committee for the safety of medicinal products of the Spanish Agency for Medicinal Products and Sanitary Products.

Article 55. Pharmacoepidemiology and risk management.

The Spanish Agency for Medicines and Health Products will promote the conduct of the pharmacoepidemiology studies necessary to evaluate the safety of authorized and registered medicinal products under real conditions of use. It shall also establish appropriate measures for the management of the identified risks, including the necessary training and information. The health authorities of the autonomous communities and healthcare professionals will participate in the performance of these studies and will collaborate in the dissemination of knowledge on the safety of the drugs in the care field.

Article 56. Objectivity in the security assessment.

The Spanish Agency for Medicines and Health Products will count, for the development of the tasks related to pharmacovigilance in the National Health System, with a committee of independent experts that will advise and participate in the evaluation of new evidence on the safety of authorised and registered medicinal products. The Committee will propose the necessary measures to minimise the risks associated with the use of medicinal products and to maintain the appropriate balance in the benefit/risk ratio of medicinal products, especially as regards new medicinal products. The evaluation reports of the new evidence on the safety of authorised medicinal products and the recommendations of the committee shall be of a public nature.

Article 57. Veterinary pharmacovigilance.

1. The Spanish Agency for Medicinal Products and Sanitary Products shall ensure that the safety of veterinary medicinal products is maintained for both animals and persons or the environment.

2. The Spanish Agency for Medicinal Products and Sanitary Products shall evaluate the information of suspected adverse reactions attributable to veterinary medicinal products received from the professionals involved in their prescription, distribution and use, as well as as of the laboratories holding veterinary medicinal products. It shall also promote the implementation of veterinary pharmacovigilance programmes and shall integrate information on detected adverse reactions into the relevant European and international networks. It shall also promote the conduct of the pharmacoepizootiology studies necessary to assess the safety of authorised veterinary medicinal products under actual conditions of use.

3. For the purpose of evaluating information on the safety of medicinal products, the Spanish Agency for Medicines and Health Products will have a committee of independent experts to advise and participate in the assessment of new evidence. on the safety of veterinary medicinal products. The Committee shall propose the measures necessary to minimise the risks associated with the use of medicinal products in such a way that it is possible to maintain the appropriate balance in the benefit/risk ratio for both animals and health. public.

TITLE III

From research on medicinal products for human use and their guarantees

Article 58. Clinical trials and observational studies.

1. For the purposes of this law, 'clinical trial' means any research carried out in humans for the purpose of determining or confirming the clinical, pharmacological and/or other pharmacodynamic effects and/or the detection of reactions and/or to study the absorption, distribution, metabolism and elimination of one or more investigational medicinal products in order to determine their safety and/or their efficacy.

All clinical trials, including bioavailability and bioequivalence studies, shall be designed, performed and communicated in accordance with the standards of "good clinical practice" and with respect to rights, safety and welfare of the test subjects, which shall prevail over the interests of science and society.

The health authorities should facilitate the conduct of clinical trials in the National Health System, both in the field of primary care and in the hospital. The conditions for the development of clinical trials in the health services of the National Health System shall be established by virtue of the agreements established between the promoter and the health services of the autonomous communities with criteria for transparency and as laid down in this law. Such agreements shall include all aspects necessary for the proper conduct of the test, including the professional participants, the resources involved and the compensation to be established.

2. For the purposes of this law, 'observational study' means the study in which the medicinal products are prescribed in the usual manner, in accordance with the conditions laid down in the authorisation. The assignment of a patient to a particular therapeutic strategy will not be decided in advance by the protocol of an essay, but will be determined by the usual practice of medicine. The decision to prescribe a particular medicinal product will be clearly dissociated from the decision to include the patient in the study. No intervention will be applied to patients, either diagnostic or follow-up, other than the usual clinical practice. Epidemiological methods shall be used for the analysis of the data collected. In any case, the observational studies shall not be subject to the provisions of this Title.

Article 59. Guarantees of suitability.

1. Clinical trials with investigational medicinal products shall be subject to authorisation by the Spanish Agency for Medicinal Products and Sanitary Products, in accordance with the regulatory procedure laid down.

2. The Spanish Agency for Medicinal Products and Sanitary Products may at any time interrupt the conduct of a clinical trial or require the introduction of modifications to its protocol, in the following cases:

a) If the law is violated.

b) If the conditions of your authorization are altered.

(c) If the ethical postulates referred to in Article 60 are not fulfilled.

d) To protect the health of test subjects.

e) In defense of public health.

3. The health administrations will have inspection powers in the field of clinical trials, and can investigate even the individual clinical histories of the test subjects, always keeping their character confidential. They may also make the precautionary interruption of the test for any of the reasons set out in the previous paragraph, immediately communicating it to the Spanish Agency for Medicines and Health Products.

4. The health authorities shall ensure compliance with the standards of "good clinical practice", carrying out appropriate inspections, with persons of due qualification and university training in medicine, pharmacy, pharmacology, toxicology or other relevant materials.

5. For the purposes referred to in paragraph 2, the investigator of a test shall immediately notify the sponsor of all serious adverse events, except in the case of those referred to in the protocol as events which do not require immediate communication. The sponsor shall, in turn, notify the Spanish Agency for Medicinal Products and Sanitary Products in the shortest possible time of the serious and unexpected adverse reactions arising during the trial and shall also send periodic reports of security. The sponsor must also keep a detailed record of all the adverse events notified to him, whose communication to the Health Administrations and to the Ethical Committee of Clinical Research must be carried out in the terms and time-limits to be established.

6. The clinical trial method shall be such that the assessment of the results obtained with the application of the test substance or medicinal product is controlled by comparison with the best reference standard, in order to ensure their objectivity, except for exceptions imposed by the nature of their own investigation.

7. The performance of the test shall in any case be adjusted to the content of the research protocol of each test according to which the authorisation would have been granted, as well as to its subsequent modifications.

8. The favourable or unfavourable results of each clinical trial, whether or not it comes to an end, should be communicated to the Spanish Agency for Medicines and Health Products, without prejudice to its communication to the Spanish Agency. the autonomous communities in which such clinical trials have been conducted.

Article 60. Guarantees of respect for ethical postulates.

1. Clinical trials must be carried out in conditions of respect for the fundamental rights of the person and the ethical postulates affecting the biomedical research in which human beings are affected, and for this purpose, content of the Helsinki Declaration and any other international instruments signed by Spain in this field.

2. No clinical trial may be initiated as long as sufficient scientific data and in particular pharmacological and toxicological tests on animals are not available to ensure that the risks involved in the person in question are admissible.

3. In order to avoid outdated or repetitive investigations, clinical trials may only be initiated to demonstrate the efficacy and safety of the proposed therapeutic modifications, provided that there are reasonable doubts about them.

4. The subject of the trial shall give its consent freely, in writing, after having been informed of the nature, importance, implications and risks of the clinical trial. If the subject of the test is not in a position to write, he may, in exceptional cases, give his or her verbal consent in the presence of at least one older witness with the capacity to act. The subject participant in a clinical trial or his/her representative may at all times revoke his consent without an expression of cause.

In the case of persons who cannot freely issue their consent, the consent must be granted by their legal representative after instruction and exposure to the same of the scope and risks of the trial. The conformity of the representative shall also be necessary if the conditions allow it to understand the nature, importance, extent and risks of the test.

5. The provisions of the above paragraph shall be without prejudice to the provisions of Article 9.2 of Law 41/2002 of 14 November 2002 on the autonomy of the patient and of rights and obligations relating to information and documentation. clinical, in terms that are regulated as determined.

6. No clinical trial may be conducted without a favourable prior report of an Ethical Clinical Research Committee, which will be independent of the promoters and researchers and the health authorities. The Committee shall be accredited by the competent authority of the Autonomous Community, which shall ensure the independence of the Community. The accreditation shall be communicated to the Spanish Agency for Medicinal Products and Sanitary Products by the competent organ of the respective Autonomous Community.

7. The Ethical Committees of Clinical Research will be formed, at least, by an interdisciplinary team consisting of physicians, primary and hospital care pharmacists, clinical pharmacologists, nursing staff and people outside the field. health professions from which at least one will be licensed under specialist law in the field.

8. The Clinical Research Ethics Committee will weigh the methodological, ethical and legal aspects of the proposed protocol, as well as the balance of risks and anticipated benefits of the trial.

9. The Clinical Research Ethics Committees may require complete information on the sources and the amount of the trial funding and the distribution of expenditure in, inter alia, the following paragraphs: reimbursement of expenses to patients, payments for special analyses or technical assistance, purchase of equipment, equipment and materials, payments due to hospitals or to the centres in which the investigation is carried out for the use of their resources and compensation to the investigators.

10. The procedure for the designation of the Etic Reference Committee and for obtaining the single opinion with validity throughout the territory will be established, with the aim of promoting clinical research in the National System of Health. The Ministry of Health, Social Services and Equality will develop actions to enable accredited Clinical Research Committees to share appropriate quality standards and assessment criteria.

Article 61. Guarantees of assumption of responsibilities.

1. The conduct of a clinical trial shall require that, by the contracting of insurance or the establishment of another financial guarantee, the coverage of the damage and damage which, for the person in which it takes effect, is guaranteed in advance. could be derived from that.

2. Where, for all circumstances, the insurance does not cover entirely the damage caused, the sponsor of the test, the investigator responsible for the test and the hospital or centre in which it has been carried out shall be jointly and severally liable for the damage. The burden of proof is to be blamed. Neither the administrative authorisation nor the report of the Ethical Committee of Clinical Research shall exempt them from liability.

3. It is presumed, unless proof to the contrary, that the damage affecting the health of the person subject to the test, during the course of the test and within a period of one year since its completion, have occurred as a result of the test. However, upon completion of the year, the subject of the year is obliged to prove the damage and nexus between the test and the damage produced.

4. The clinical trial promoter is the natural or legal person who has an interest in carrying out the clinical trial, signs the application for authorization to the Ethical Committee of Clinical Research and the Spanish Agency for Medicines and Health Products. holds the responsibility.

5. It is the principal investigator who directs the application of the application and the application, corresponding to the application. The condition of the promoter and the principal investigator may be on the same natural person.

Article 62. Guarantees of transparency.

1. Clinical trials authorised by the Spanish Agency for Medicinal Products and Health Products shall form part of a national register of public and free clinical trials which shall be accessible under the conditions to be determined.

2. The promoter is obliged to publish the results of the clinical trial, whether positive or not. The publication shall be carried out after the deletion of any commercial information of a confidential nature, preferably in scientific journals and, if not possible, by means and within the maximum time limits laid down in this Regulation. Regulation. The publication will mention the Ethical Committee of Clinical Research that informed them.

3. Where studies and research work on medicinal products for the scientific community are made public, the funds obtained by the author shall be recorded by or for the purpose of the research and the source of funding.

4. If the results of the clinical trials are not published and when the results of the clinical trials are not published, the Spanish Medicines and Health Products Agency will make changes to its efficacy or safety profile. public the results.

5. All information on the clinical trial must be recorded, processed and stored in a manner that can be communicated, interpreted and verified in a precise manner, while protecting the confidential nature of the records of the subjects. of the test.

6. The Government, after a report of the Interterritorial Council of the National Health System, and with a basic character, will regulate the common requirements for the realization and financing of clinical trials, ensuring good clinical practice and the conditions for its implementation. The centres, services, establishments and healthcare professionals shall participate in the conduct of clinical trials in accordance with these common requirements and financing conditions and those in their development may establish the competent health care.

TITLE IV

Of the guarantees required in the manufacture and distribution of medicinal products

CHAPTER I

From the manufacture of medicines

Article 63. Authorisation of the pharmaceutical laboratory.

1. For the purposes of this law, natural or legal persons engaged in the manufacture of medicinal products or any of the processes which the latter may understand, including fractionation, packaging and presentation for sale, must be be authorized by the Spanish Agency for Medicines and Health Products. Such authorisation shall also be necessary for the importation and placing on the market of medicinal products, and even for the assumption that the medicinal product is manufactured exclusively for export. The Spanish Agency for Medicinal Products and Sanitary Products shall make public the authorization and its modifications and the extinction thereof.

2. In order to obtain the authorisation of a pharmaceutical laboratory, the applicant shall meet the following requirements:

(a) Detailed the medicines and pharmaceutical forms you intend to manufacture, as well as the place, establishment or laboratory of manufacture and control.

b) Dispose of premises, technical equipment and control, adequate and sufficient for proper manufacturing, control and conservation that meets the legal requirements.

c) Dispose of a responsible technical director, a manufacturing officer, and a quality control officer. All of them must comply with the professional and functional conditions which they regulate. Laboratories that manufacture small quantities or simple products may attribute the control function to the technical director, but the manufacturing address must correspond to a different person.

Article 64. Guarantees for the correct manufacture of medicinal products and raw materials.

1. Without prejudice to any other obligations arising from a statutory or regulatory provision, the pharmaceutical laboratory shall fulfil the following obligations:

(a) Dispose of sufficient personnel and with the technical qualification necessary to ensure the quality of the medicinal products and the execution of the controls carried out in accordance with the provisions of the law.

b) Provide medicines in accordance with current legislation.

c) Having supplied the market with the registered products, in an appropriate and continuous manner to enable compliance with the operational requirements referred to in Article 69.1, which may be suspended supply only in duly justified exceptional cases after the authorisation of the Spanish Agency for Medicinal Products and Sanitary Products has been granted.

d) Allow, at all times, access to your premises and files to the competent authorities for inspections.

e) Facilitate the performance of their duties to the technical director and ensure that they have the necessary means to do so.

(f) To respond to the obligations that are due to them during the time of their activity, including in the event of suspension of the activity, and during the five years after its closure.

g) Ensuring that the transport of the medicinal products to destination, whether to distribution entities or to services or pharmacy offices, is carried out in compliance with the obligations imposed on the authorization of the same and the rules for correct distribution of medicinal products.

h) Adjust to the requirements of the regulations of the autonomous communities the activities of promotion, advertising and sponsorship carried out by the laboratories.

i) Communicate to the Ministry of Health, Social Services and Equality the units of medicines sold to be dispensed in the national territory, including lot numbers regardless of the final destination.

j) Communicate the suspension or cessation of your activities.

2. Pharmaceutical laboratories must comply with the correct manufacturing standards published by the Ministry of Health, Social Services and Equality, in accordance with the detailed guidelines on good manufacturing practice for medicinal products. established within the Community framework.

Furthermore, manufacturers and distributors of active substances used as raw materials must comply with the rules of correct manufacturing of active substances and good practices for the distribution of active substances, published by the Ministry of Health, Social Services and Equality. For such purposes, the term 'manufacture of active substances used as raw materials' means the complete or partial manufacture or the importation of an active substance used as a raw material, as defined in Article 2, and the various processes of division, conditioning and presentation prior to incorporation into a medicinal product, including reconditioning and relabelling.

The pharmaceutical laboratory may only use as raw materials active principles manufactured in accordance with the rules of correct manufacturing of active and distributed principles in accordance with good practice. distribution of active principles. To this end, the pharmaceutical laboratory shall verify compliance by the manufacturer and the distributors of the active principles of the correct manufacturing standards and good distribution practices by means of the audits in the manufacturing and distribution facilities of the manufacturers and distributors thereof. The pharmaceutical laboratory shall verify such compliance by itself or, without prejudice to its liability in accordance with the provisions of this law, through an entity acting on behalf of it under a contract.

3. The pharmaceutical laboratory shall ensure that the excipients are suitable for use in a medicinal product by determining appropriate manufacturing practices, with a formal risk assessment carried out in accordance with the guidelines. (a) applicable in the case of the correct manufacturing of medicinal products as well as those laid down in the Community framework.

4. The pharmaceutical laboratory shall carry out the quality checks carried out on the raw materials, the intermediate manufacturing products and the finished product in accordance with generally accepted methods and techniques.

5. For the purposes of complying with the above paragraph, each pharmaceutical laboratory shall have a unit of control and quality assurance of the products, processes and procedures with the authority and responsibility to accept or reject raw materials, intermediate and final products. Manufacturing processes and procedures shall be validated.

6. Manufacturers of medicinal products and medical devices must have an equivalent insurance, guarantee or financial guarantee to respond to health damage arising from the safety of medicinal products, in terms of Regulations are available.

Article 65. Modification, suspension and revocation of the authorization.

1. Any modification of the requirements referred to in paragraphs (a) and (b) of Article 63.2 or the subject of the authorisation shall be approved in advance by the Spanish Agency for Medicinal Products and Sanitary Products.

2. The replacement of the technical director shall be communicated to the Spanish Agency for Medicinal Products and Sanitary Products and to the competent authority of the Autonomous Community.

3. The Spanish Agency for Medicinal Products and Sanitary Products may suspend or revoke the authorisation of the laboratory, for a given category of products or for all products, where the requirements and/or obligations laid down in the this chapter. It may also suspend or revoke it when the laboratory does not comply with good pharmacovigilance practice or does not perform in time and form studies which, for such purposes, are required in this law.

Article 66. Manufacture by third parties.

1. Pharmaceutical laboratories may entrust third parties with the production of manufacturing activities or controls provided for in this law for medicinal products, if the following requirements are met:

(a) The third-party contract shall have the authorization referred to in Article 63.

(b) The Spanish Agency for Medicinal Products and Health Products shall specifically authorise the manufacture by third parties.

2. Exceptionally, and where the care is required for their patients, the hospital pharmacy services and pharmacy offices may entrust to an entity legally authorised by the Spanish Agency for Medicines and Health Products the implementation of any stage of production of a particular preparation or of its analytical control.

CHAPTER II

From Drug Distribution

Article 67. Guarantees of accessibility and availability of medicines.

1. The distribution of the authorised medicinal products shall be carried out either through distribution entities or directly by the laboratory that is the holder of the marketing authorisation.

2. The distribution activity must guarantee a quality service, with its priority and essential function being the supply to the pharmacy offices and to the pharmacy services legally authorized in the national territory.

3. The use of third parties by a laboratory or distribution entity for the distribution of medicinal products shall be included in the relevant authorisation as a laboratory or distribution entity.

Article 68. Administrative control of the wholesale distribution.

1. Wholesale warehouses, as well as contract warehouses, shall be subject to prior authorization from the autonomous community where the warehouse is domiciled. However, the warehouse must communicate the performance of its activities to the health authorities of the autonomous communities where, not being domiciled, such activities are carried out.

Distribution entity authorization may include contract warehouse activity.

2. Without prejudice to the powers of the autonomous communities, the distribution entity and, where appropriate, the laboratory holder of the marketing authorisation shall communicate directly to the Spanish Agency for Medicinal Products and Products Healthcare the start of your activities.

3. Without prejudice to paragraph 1, the warehouses of medicinal products under control or customs supervision shall be subject to prior authorisation as a distribution entity for medicinal products to be granted by the Spanish Agency of Medicines and Healthcare products.

Article 69. Operational requirements.

1. Distribution entities and, where appropriate, pharmaceutical laboratories which distribute their products directly shall be obliged to:

a) To have premises and equipment equipped with personal, material and technical means to ensure the correct preservation and distribution of the medicines, with full guarantee for public health.

b) To ensure compliance with the general or particular conditions for the preservation of medicinal products, and in particular the maintenance of the cold chain throughout the distribution network through procedures normalised.

c) To maintain minimum stocks of medicinal products to ensure adequate continuity of supply.

d) To ensure delivery times, minimum frequency of deliveries, permanent pharmaceutical technical advice and means of support to pharmacy offices and services.

e) To meet guard and disaster prevention services.

(f) To have an emergency plan to ensure the effective implementation of any market withdrawal ordered by the competent health authorities.

g) To have an alert system in place that covers all pharmacies in the territory of its scope of action.

h) To comply with the standards of good distribution practices that have been promoted or authorized by the competent health administrations and to collaborate with them to ensure a quality pharmaceutical delivery.

i) To the fulfilment of any other obligations arising out of legal or regulatory provision.

2. The government, with a basic character, may lay down the minimum requirements and conditions for these establishments in order to ensure the forecasts contained in the previous paragraph. The Government shall ensure that the right of the distribution entity to be supplied by the laboratories is preserved.

Article 70. Technical director.

All distribution entities authorized in accordance with Article 68 shall have a pharmaceutical technical director, whose charge shall be incompatible with other activities of a health nature involving direct interests with the manufacture or dispensing of medicinal products or which are detrimental to the proper performance of their duties.

The Government will establish the technical director's duties.

Article 71. Intermediation in the distribution of medicinal products for human use.

1. Persons engaged in the distribution of medicinal products for human use established in Spain must register, prior to the commencement of their activity, in a register which the Spanish Agency for Medicinal Products and Health Products shall maintain for this purpose, which shall include all data to be laid down in a regulatory manner. The health authorities of the Autonomous Communities shall have access to the complete data of this register for inspection purposes. This record will be publicly accessible.

2. Persons engaged in the trading of medicinal products shall comply with the obligations arising from the rules in force as well as the specific provisions included in the good distribution practices of the medicines published by the Ministry of Health, Social Services and Equality.

TITLE V

From the health guarantees of the foreign trade of medicines

Article 72. Imports.

1. Without prejudice to other legal or regulatory requirements, only authorised and registered medicinal products may be imported into the Register of Medicinal Products in accordance with the requirements laid down in this Law.

2. The distribution of medicinal products shall comply with the requirements laid down in Title IV. For this purpose, the importer may use the pharmaceutical channels which are legally authorised to do so or to be a distribution entity after the corresponding authorisation granted in accordance with Chapter II of Title IV.

3. The technical director of the importing entity guarantees the conformity of the imported batches and replies that each batch of imported manufacture has been the subject of a full qualitative analysis in Spain, of a quantitative analysis referred to above. less, to all the active substances and other controls which are necessary to ensure their quality in accordance with the terms of the authorisation and registration of the medicinal product.

For this purpose, the documentation and samples that are regulated for control by the Ministry of Health, Social Services and Equality shall be provided.

4. The checks referred to in the previous paragraph shall be deemed to have been carried out when the Ministry of Health, Social Services and Equality has established, in the country of origin, that the same requirements have been met. provided for in this law, without prejudice to the obligations arising from membership of the European Union and other international treaties concluded by Spain.

5. The importation of "investigational medicinal products" will require prior authorisation from the Spanish Agency for Medicines and Health Products.

6. The holder of a medicinal product in Spain may not prevent its importation and placing on the market by third parties provided that he is placed on the Spanish market with the guarantees laid down by this law with the adaptations which he/she regulates determine.

7. Natural or legal persons engaged in the importation of medicinal products, raw materials or medical devices must, on the same terms as manufacturers, have an equivalent insurance, guarantee or financial guarantee to the health damage resulting from the safety of medicinal products, in accordance with the provisions of this Regulation.

Article 73. Exports.

1. Laboratories and distribution entities that comply with the legally established requirements may export medicinal products.

2. The export of authorised and registered medicinal products shall be notified by the exporter to the Spanish Agency for Medicinal Products and Sanitary Products in the cases and terms which are regulated.

3. The product shall not be required to export the requirements laid down by this law for authorisation as a medicinal product in Spain, in respect of format or presentation, texts, labelling and packaging characteristics, provided that they are complied with. the principles that this law provides for information guarantees to professionals and users.

Article 74. Medicinal products intended for the treatment of travellers.

1. Medicinal products accompanying travellers intended for their own administration or treatment are excluded from the requirements laid down in the preceding Articles, without prejudice to control measures where such medicinal products may be represent a deviation from its amount or destination especially in the prevention of its illicit use.

2. Public administrations shall take the necessary measures to prevent the products covered by this law, under transit to a third country, from being diverted for use in Spain without complying with the requirements laid down in this Directive. law.

3. In accordance with the provisions of the legislation on health protection and the fight against doping in sport, sportsmen, sports teams or groups and the foreign directors representing them are obliged, when they enter Spain for participate in a sporting activity, to send duly completed to the Spanish Agency for Health Protection in Sport the forms that it establishes, in which the products they carry for their use are identified, units of the same and the doctor responsible for their prescription or, in the case of animals which participate in sporting events, the veterinarian.

TITLE VI

From the registration of pharmaceutical laboratories and the registration of manufacturers, importers or distributors of active substances

Article 75. Registration of pharmaceutical laboratories.

1. The Spanish Agency for Medicinal Products and Sanitary Products will maintain a register of pharmaceutical laboratories that will include all the data that they are required to supply in order to comply with the provisions of this law. This record will be publicly accessible.

2. Registration of the initial authorization, as well as any transmission, modification or extinction, is mandatory.

Article 76. Registration of manufacturers, importers or distributors of active substances.

1. The Spanish Agency for Medicinal Products and Sanitary Products shall maintain a register of manufacturers, importers or distributors of active substances, which shall include all the data to be laid down in a regulatory manner. The health authorities of the autonomous communities shall have access to the complete data of this register for inspection purposes. The data in this registry will be publicly accessible.

2. Registration in this register is required prior to the start of the manufacturing, import or distribution activity as well as the immediate remission of any changes in the data provided that may have an impact on the quality, the safety or effectiveness of the active substances. In addition, the submitted data will be updated annually.

TITLE VII

The rational use of medicinal products for human use

CHAPTER I

From guarantees of training and independent and quality information for the proper use of medicines and medical devices

Article 77. Guarantees of public administrations.

1. The public administrations responsible for health and education orders will direct their actions to promote continuous and permanent university and post-university education on medicines, therapeutics and medical devices. healthcare professionals.

2. Public health administrations will direct their actions to implement an agile, effective and independent system that will ensure that health professionals provide scientific, up-to-date and objective information on medicines and products. health.

3. The public administrations will direct their actions to promote the establishment of own information centers for medicines and medical devices, by promoting and coordinating the use of resources and technologies. information enabling professional health institutions and other entities to access information on such products.

4. Public health administrations shall promote the publication of pharmacological and/or pharmacotherapeutic guides for the use of healthcare professionals.

5. Public health administrations will carry out health education programmes on drugs aimed at the general public by promoting actions that promote better knowledge of medicines to improve compliance therapeutic, to avoid risks arising from misuse and to raise awareness among citizens of the economic value of the medicinal product.

Article 78. Objectivity and quality of information and promotion to healthcare professionals.

1. The information and promotion directed to healthcare professionals, under the control of the health administrations in the terms provided for in article 102.1 of Law 14/1986, of 25 April, General of Health, must agree with the technical and scientific information authorised by the Spanish Agency for Medicinal Products and Sanitary Products and shall be rigorous, well-founded and objective and not mislead, in accordance with the legislation in force, and conform to the technical information sheet.

2. The information and promotion may be carried out through written, audiovisual or other media, exclusively aimed at health professionals and will be of a scientific nature. In the case of reports or articles financed by a pharmaceutical laboratory or related entity, this circumstance shall be specified in the publication.

3. In the case of information or promotion distributed by computer means, the health authorities may access it for the purposes of inspection.

4. Offers of prizes, scholarships, contributions and grants to meetings, congresses, study trips and similar acts by any person, natural or legal, related to the manufacture, manufacture, distribution, prescription and supply of medicines and medical devices shall be made public in the form that is determined to be regulated and shall apply exclusively to activities of a scientific nature where the recipients are healthcare professionals or the entities in which they are associate. In the programmes, publications and presentations of meetings, congresses and similar events, the source of funding for the programmes and the funds obtained from each source shall be recorded. The same obligation shall apply to the means of communication by which the public is made public and which obtains funds for or for publication.

Article 79. The prescription and hospital prescription.

1. The medical prescription, public or private, and the order of hospital dispensing are the documents that ensure the establishment of a treatment with medication by instruction of a doctor, a dentist or a podiatrist, in the field of their competencies respective, unique professionals with the ability to prescribe medicinal products subject to medical prescription.

Without prejudice to the foregoing, nurses shall, autonomously, indicate, use and authorize the dispensing of all medicinal products not subject to medical prescription and medical devices related to their exercise. professional, by means of the corresponding dispensing order. Physiotherapists may also indicate, use and authorize, autonomously, the dispensing of medicinal products not subject to medical prescription and medical devices related to the exercise of their profession, by order of supply.

The Government will regulate the indication, use and authorization of dispensing of certain medications subject to medical prescription by nurses, in the framework of the principles of comprehensive health care and for continuity. care, through the application of protocols and guidelines of clinical and care practice, of joint development, agreed with the medical and nursing collective organizations and validated by the Directorate General of Public Health, Quality and Innovation of the Ministry of Health, Social Services and Equality.

The Government will also regulate the indication, use and authorization of dispensing of certain medications subject to medical prescription by nurses, in the field of general and specialized care, and establish, with the participation of the collective organizations of nurses and physicians, the general criteria, specific requirements and procedures for the accreditation of these professionals, with effects throughout the territory of the State, actions provided for in this paragraph.

The Ministry of Health, Social Services and Equality, with the participation of the corresponding collegiate organizations, will demonstrate with effects throughout the State to the nurses and the physiotherapists for the actions provided for in this Article.

2. The pharmacist will dispense with prescription those medicines that require it. This requirement must be expressly specified in the packaging of the medicinal product.

3. The medical prescription shall be valid throughout the national territory and shall be published in the official Spanish language of the State and in the respective co-official languages in the autonomous communities which have it.

4. Medical prescriptions and hospital orders for dispensing must contain the basic data for identification of prescribers, patients and medications.

5. In prescriptions and hospital orders for dispensing, the optional will include the relevant warnings for the pharmacist and for the patient, as well as the instructions for better follow-up of the treatment through the procedures of the pharmaceutical care, in order to ensure the achievement of the health objectives of those.

6. The Government may, on a basic basis, regulate the provisions of the above paragraphs and lay down the requirement for other requirements which, in order to affect public health or the health system, must be applied in general to medical or medical prescriptions. hospital orders.

7. The formalities to which prescriptions and medical orders are submitted, and especially in their processing, shall comply with the provisions of Article 10 of Law 14/1986 of 25 April.

8. The Government shall determine on a basic basis the minimum requirements to be met by medical prescriptions extended and/or edited in computerised form in order to ensure the accessibility of all citizens, under conditions of effective equality. in the whole of the Spanish territory, to the pharmaceutical provision of the National Health System.

The consent of the data subject shall not be required for the processing and transfer of data that is a consequence of the implementation of medical prescription based information systems on paper or electronic support, in accordance with the provisions of Articles 7 (3) and 7 (6); and Article 11 (2) (a) of the Organic Law 15/1999 of 13 December on the Protection of Personal Data. The above mentioned actions should aim to facilitate medical and pharmaceutical assistance to the patient and to enable the control of the pharmaceutical provision of the National Health System.

9. Public health administrations will carry out health education programs aimed at the general population, aimed at highlighting the importance of the medical prescription as a guarantee of quality and safety of patients.

10. The provisions of this Article shall also apply to the veterinary prescription, in which case the references to the doctor and dentist shall be construed as being made to the veterinarian.

Article 80. Guarantees on the advertising of medicinal products and medical devices intended for the general public.

1. Medicinal products which meet all the requirements listed below may be the subject of advertising intended for the public:

a) That they are not funded by public funds.

b) Which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a doctor who performs the diagnosis, prescription or follow-up of the treatment, even if they require the intervention of a pharmacist. This requirement may be waived where vaccination campaigns approved by the competent health authorities are carried out.

(c) that they do not constitute psychotropic or narcotic substances within the meaning of international conventions.

2. The advertising of a medicinal product which is the subject of advertising to the public shall comply with the requirements laid down in paragraph 1 of this Article; for its part, advertising messages shall meet the following requirements:

(a) That the advertising character of the message is evident and clearly specified that the product is a medicinal product.

(b) To include the name of the medicinal product in question, as well as the common name when the medicinal product contains a single active substance.

c) That all the information essential for the correct use of the medicinal product be included as well as an express and clearly visible invitation to read carefully the instructions given in the package leaflet or in the external packaging, as the case may be, and the recommendation to consult the pharmacist on its correct use.

d) Not include expressions that provide healing security, nor testimonials about the virtues of the product, or of professionals or people whose notoriety can induce consumption.

e) Do not use as an advertising argument the fact that they have obtained health authorization in any country or any other authorization, health registration number or certification that corresponds to the issue, or the controls or the analysis that it is the responsibility of the health authorities to carry out in accordance with the provisions of this law.

(f) Advertising messages for medicinal products that are issued in audiovisual media shall comply with the conditions of accessibility for persons with disabilities established in the legal order for advertising institutional.

3. Advertising of medicinal products not subject to medical prescription shall not require prior administrative authorization, but the competent health authorities shall carry out the necessary checks to ensure that the advertising content comply with the laws and regulations, which are applicable to them and which are in accordance with the scientific and technical conditions laid down in the marketing authorisation.

4. Health administrations may, for reasons of public health or safety, limit, condition or prohibit the advertising of medicinal products and medical devices.

5. Premiums, gifts, prizes, contests, bonuses or similar are prohibited as methods linked to the promotion or sale to the public of these medicines.

6. In the case of medical devices, the possibility of direct or indirect advertising, directed to the public in the event that a product is financed by the National Health System, is excluded. This advertising ban affects the manufacturers, distributors or marketing companies, as well as all those entities that can maintain direct contact with the patient. Also, premiums, gifts, discounts, prizes, contests, bonuses or similar are prohibited as methods linked to the promotion or sale to the public of such products.

7. Medical devices intended to be used or applied exclusively by healthcare professionals shall not be the subject of advertising intended for the public.

8. The advertising of medical or surgical techniques or procedures linked to the use of specific medical devices shall respect the criteria laid down in the advertising of medical devices.

Article 81. Guarantees in the advertising of products with supposed properties on health.

The advertising and commercial promotion of products, materials, substances or methods to which beneficial effects on health are attributed shall be regulated.

Article 82. Rational use of medicines in sport.

The import, export, distribution, marketing, prescription and dispensing of medicinal products, legally recognized, will not be intended to increase the physical abilities of the athletes or to modify the results of the competitions in which they participate, and must be adjusted in their development and objectives to the implementing rules in the field.

CHAPTER II

From the rational use of drugs in primary health care

Article 83. Support structures for the rational use of medicinal products and medical devices in primary care.

1. Without prejudice to the responsibility that all healthcare professionals have in the rational use of medicinal products, primary care management structures must have primary care pharmacy services or units.

2. In order to contribute to the rational use of medicinal products, primary care pharmacy units or services shall perform the following functions:

(a) Ensure and assume the technical responsibility of the acquisition, quality, correct conservation, coverage of the needs, custody, preparation of master formulas or official preparations and dispensation of the medicines to be applied within primary care centres and those for which particular surveillance, supervision and control are required, as provided for in Article 103 of Law 14/1986 of 25 April, General Health and in the regulatory provisions that develop it.

b) Establish an effective and safe distribution system for medicines and medical devices in the centres and structures of their care.

c) Establish information systems on pharmacotherapy management including clinical aspects, effectiveness, safety and efficiency of the use of medicinal products and provide correct information and training on medicinal products and medical devices to healthcare professionals.

d) Develop pharmacotherapeutic protocols and guidelines to ensure the correct pharmacotherapeutic assistance to patients, especially regarding the selection of drugs and the continuity of treatment and treatment systems. support for clinical decision-making in drug therapy.

e) To promote the coordination in pharmacotherapy between different health structures and care levels and to promote clinical research in quality pharmacotherapy and appropriate to the needs of patients, guaranteeing the correct custody and dispensing of the products in clinical research phase.

f) Establish a system for monitoring patients ' treatments to help ensure therapeutic compliance as well as programs that enhance the safe use of medicines.

g) Promoting and participating in population education programmes on drugs, their rational use and prevention of their abuse and forming part of commissions related to the rational use of medicines and products health.

h) To promote coordination and teamwork and collaboration with hospitals and specialized care services, in order to ensure the quality of the pharmaceutical delivery through the follow-up of treatments prescribed by the doctor.

i) Performing as many functions as possible in better use and control of drugs, through collaborative strategies among healthcare professionals in primary care teams.

3. All of the above shall also apply to medical devices except in cases where it is impossible to apply them by the nature of the product itself.

CHAPTER III

The rational use of medications in hospital and specialty care

Article 84. Support structures for the rational use of medicines in hospitals.

1. Without prejudice to the responsibility that all healthcare professionals have in the rational use of medicinal products, hospitals must be provided with services or hospital pharmacy units in accordance with the established minimum conditions. by this law. Hospitals at the highest level and those that are determined must have services or units of Clinical Pharmacology.

2. In order to contribute to the rational use of medicinal products, hospital pharmacy units or services shall perform the following functions:

(a) Ensure and assume the technical responsibility of the acquisition, quality, correct conservation, coverage of the needs, custody, preparation of master formulas or official preparations and dispensation of the precise medicinal products for intra-hospital activities and for those for extra-hospital treatment, as laid down in Article 3.6.

b) Establish an effective and safe distribution system for medicinal products, take measures to ensure proper administration, safeguard and dispense products in the clinical investigation phase and ensure compliance with the legislation on medicinal products for psychoactive substances or any other medicinal product requiring special control.

(c) Forming part of the hospital commissions in which their knowledge for the scientific selection and evaluation of the medicinal products and their use can be useful.

d) Establish a drug information service for all hospital staff, an intra-hospital pharmacovigilance system, systematic studies of drug use, and pharmacokinetic activities clinic.

e) Conduct educational activities on issues of their competence to the hospital's healthcare personnel and patients.

f) To carry out own research work or in collaboration with other units or services and to participate in clinical trials with medicinal products.

g) Collaborate with the primary and specialized care structures of the area in the development of the functions outlined in Article 83.

h) Performing as many functions as possible in better use and control of medications.

i) Participate and coordinate the management of the hospital's purchase of medicines and medical devices for the purpose of ensuring the hospital's efficiency.

3. The functions defined in paragraphs (c) to (h) of the preceding paragraph shall be developed in collaboration with clinical pharmacology and other hospital units or clinical services.

Article 85. Hospital pharmacy.

1. Hospital pharmacy services will be under the ownership and responsibility of a hospital pharmacy specialist pharmacist.

2. Health administrations with competence in pharmaceutical management will perform such a function in the hospital pharmacy while maintaining the following criteria:

a) Setting requirements for proper operation, in line with established functions.

b) That the actions be performed with the presence and professional performance of the pharmacists or pharmacists needed for proper assistance.

(c) Pharmacists in hospital pharmacies must have completed the studies of the relevant specialty.

3. Hospitals that do not have pharmaceutical services will have to request authorization from the autonomous communities to maintain a drug depot under the supervision and control of a pharmacist. The conditions, requirements and operating rules for such deposits shall be determined by the competent health authority.

CHAPTER IV

The rational use of medicines in pharmacy offices

Article 86. Pharmacy offices.

1. At the pharmacy offices, pharmacists, as responsible for dispensing medicinal products to the public, will ensure compliance with the guidelines established by the doctor responsible for the patient's prescription and will cooperate with him in the monitoring of treatment through the procedures of pharmaceutical care, contributing to ensure its efficacy and safety. They shall also participate in the implementation of all activities aimed at the rational use of the medicinal products, in particular through the provision of the patient's informed consent. Once the medicine has been dispensed, it will be able to provide personalized dosing systems to patients who request it, in order to improve the therapeutic compliance, in the treatments and with the conditions and requirements established by the competent health administrations.

2. The health authorities shall carry out the management of the pharmacy offices, taking into account the following criteria:

a) General planning of pharmacy offices in order to ensure adequate pharmaceutical assistance.

b) The presence and professional performance of the pharmacist as a condition and inexcusable requirement for the supply to the public of medicinal products, taking into account the number of pharmacists needed according to the activity of the office.

(c) The minimum material, technical and media requirements, including accessibility for persons with disabilities, which the Government establishes on a basic basis to ensure the provision of proper health care, without prejudice to the powers conferred on the autonomous communities in this field.

3. Pharmacy offices are required to dispense medicines that are required by individuals and by the National Health System under established regulatory conditions.

4. For reasons of emergency and remoteness from the office of pharmacy or other special circumstances in place, in certain establishments, the creation of kits may be authorized, exceptionally, under the conditions governing the establishment of determine on a basic basis, without prejudice to the powers conferred on the autonomous communities in this field.

5. Public administrations shall ensure the continued training of pharmacists and the appropriate certification and training of auxiliary pharmacy assistants and assistants.

6. Pharmacy offices have the consideration of private health facilities, in the public interest.

Article 87. Prescription of medicines and medical devices.

1. The prescription of medicines and medical devices in the National Health System will be made in the most appropriate way for the benefit of patients, while protecting the sustainability of the system.

2. In the National Health System, the prescriptions of medicinal products included in the reference price system or of homogeneous groupings not included in the system shall be carried out according to the following scheme:

(a) For acute processes, the prescription will be generally done on an active basis.

b) For chronic processes, the first prescription, corresponding to the introduction of the first treatment, will be done, in general, by active principle.

c) For chronic processes whose prescription corresponds to the continuity of treatment, it may be carried out by commercial denomination, provided that it is included in the reference price system or the The lowest price within its homogeneous pool.

3. However, the prescription for trade name of medicinal products shall be possible provided that the principle of greater efficiency is respected for the system and in the case of medicinal products considered as non-replaceable.

4. Where the prescription is made on an active basis, the pharmacist shall dispense the lowest-priced medicinal product in its homogeneous group and, in the case of equality, the generic medicinal product or the corresponding biosimilar medicinal product.

5. In any event, the prescription of a medicinal product for use under conditions other than those laid down in its technical fiche must be authorized, in advance, by the commission responsible for the therapeutic or collegiate protocols. equivalent in each stand-alone community.

Article 88. Information systems for prescription support.

1. The competent bodies of the autonomous communities shall provide their prescribers with a common and interoperable electronic prescription system and shall allow the recording of the information on the number of doses adjusted to the needs of the treatment, in which prescription support subsystems such as: online drug nomenclator; correspondence between active substances, available medicines and pathologies in which they are indicated; treatment of recommended pathology from health institutions and societies medical, with an indication of the standards of choice and expected benefits; cost of the prescribed treatment and alternatives of therapeutic choice, according to criteria of efficiency; database of interactions; database of clinical trials in its province or autonomous community; regular online information (authorisation and withdrawal of medicinal products and medical devices, alerts and communications of interest for the protection of public health); dissemination of news on medicinal products which, Without being alert in the strict sense, they contribute to improve the health of the population.

2. The prescription support schemes will collect the information corresponding to the selected prices via reduced input, so that the doctor can take into account the economic impact during the prescription of medicines and medical devices.

3. Prescription support systems shall be managed from the competent bodies at the level of the Autonomous Community. The Interterritorial Council of the National Health System shall ensure that they are articulated efficiently and contribute to maintaining the equity of the healthcare system.

4. The Ministry of Health, Social Services and Equality, in coordination with the Autonomous Communities, will establish basic care protocols in order to guide the prescription and use of those medicines which, by their unique characteristics, require special attention and caution in prescribing and dispensing.

Article 89. Replacement by the pharmacist.

1. The pharmacist will dispense the medication prescribed by the doctor.

2. By way of exception, where the pharmacy office of the prescribed medicinal product is not available at the pharmacy office or if there is an urgent need for dispensing, the pharmacist may replace him with the lowest price. In any case, it should have the same composition, pharmaceutical form, route of administration and dosage. The pharmacist will inform the patient about the replacement in any case and ensure that he knows the treatment prescribed by the doctor.

3. In these cases, the pharmacist will write, at the appropriate place of the prescription, the medicine of the same composition, pharmaceutical form, route of administration and dosage that you disagree with, the date, your signature and your rubric.

4. Those medicinal products which, by reason of their characteristics of bioavailability and narrow therapeutic range, shall be determined by the Ministry of Health, Social Services and Equality shall be exempted from this possibility.

5. Where the prescription is made by trade name, if the prescribed medicinal product has a higher price than the lower price of its homogeneous group, the pharmacist shall replace the prescribed medicinal product with the lowest price of its grouping. Uniform and, in the case of equality, dispense with the generic medicinal product.

In the case of biosimilar medicinal products, the rules in force shall be respected in accordance with specific rules on substitution and interchangeability.

CHAPTER V

Traceability of medicines

Article 90. Traceability guarantees.

1. In order to achieve adequate market supply and to establish security guarantees for citizens, laboratories, distribution entities, pharmacy offices, retail establishments and institutions or bodies, or Livestock groups authorised for the supply of veterinary medicinal products are subject to the reporting obligations referred to in this Article.

2. The pharmaceutical laboratories shall communicate, in the terms of a regulation, to the Ministry of Health, Social Services and Equality, the units of presentations identified by batches of medicinal products and consignee, sold on national territory, as well as those which are the subject of repayment. They shall also ensure, on the terms that they are regulated, the identification of each unit along its route, in accordance with the provisions of Article 15.4.

3. The distribution institutions shall communicate, in the terms of their regulations, to the Autonomous Community in which they have their registered office and to the Ministry of Health, Social Services and Equality, the units supplied and the returned units, with an indication of the lot to which they belong as well as the consignee, whether they are offices or services of pharmacy or of other distribution entities, irrespective of the Autonomous Community in which they radiate.

4. Without prejudice to the concerts which may be signed, the holders of the pharmacy offices shall communicate to the competent authority of the Autonomous Community where the units of the medicinal products they supply are subject to their scope. The competent bodies of the autonomous communities shall forward this information to the Ministry of Health, Social Services and Equality, in terms of their regulations.

5. The offices of pharmacy, retail establishments and livestock organizations or groups authorized to dispense veterinary medicinal products shall, in accordance with the terms to be laid down in regulation, communicate to the Spanish Agency Medicines and Sanitary Products the units of veterinary medicinal products dispensed.

6. The collection and processing of data referred to in this article must be in accordance with the current regulations regarding the security and protection of personal data, in compliance with the Organic Law 15/1999, of December 13, of Protection of Personal Data, taking into account the responsibility of their respective public ownership files, the General Administration of the State, the competent health authorities of the Autonomous Communities and, where appropriate, the Corresponding corporate administrations.

TITLE VIII

Public funding for medicines and medical devices

Article 91. Principle of territorial equality and coordination.

1. The right of all citizens to obtain medicinal products under equal conditions throughout the National Health System is recognized, without prejudice to measures aimed at rationalizing the prescription and use of medicines and products. health authorities who may adopt the autonomous communities in exercise of their powers.

2. The regulations of the Government or the Ministry of Health, Social Services and Equality and the resolutions issued by the competent management centre of the Ministry of Health, on the financing of medicinal products and medical devices National Health System shall take effect throughout the Spanish territory from the date on which they are applicable.

3. The industrial price of public financing, established by the competent authority of the Ministry of Health, Social Services and Equality, for medicinal products dispensed in pharmacy offices by means of an official medical prescription from the National System of Health shall not be the subject of an amendment or bonus, except where the same consists of a percentage or linear discount applicable throughout the national territory, without prejudice to the provisions of Article 4.6.

The forecasts contained in the previous paragraph will also apply to medical devices, once the system of financing of prices and margins of such products, which is included in the pharmaceutical provision of the National Health System.

4. Any modification of the price of a medicine or health product financed by the National Health System will take effect on the same date throughout the Spanish territory.

5. Measures aimed at rationalising the prescription and use of medicinal products and medical devices which can be adopted by the autonomous communities will not result in differences in the conditions for access to medicinal products and medical devices. financed by the National Health System, catalogue and prices. Such rationalisation measures shall be homogeneous for the entire Spanish territory and will not lead to distortions in the single market for medicinal products and medical devices.

6. The Interterritorial Council of the National Health System may agree on the general conditions for the planning, coordination, procurement, procurement and supply of medicines and medical devices for the ownership structures and services. public integrated into the National Health System.

Article 92. Procedure for public funding.

1. For the public funding of medicinal products and medical devices, it will be necessary to include them in the pharmaceutical supply by means of the corresponding express resolution of the unit responsible for the Ministry of Health, Social Services and Equality, establishing the conditions of financing and price in the field of the National Health System.

The same shall apply when an amendment to the authorisation affecting the content of the pharmaceutical supply occurs, prior to the placing on the market of the modified product, or to affect the modification to the indications of the medicinal product, either because, without affecting them, the Spanish Agency for Medicinal Products and Sanitary Products so agrees for reasons of public interest or defense of the health or safety of the persons.

The inclusion of medicines in the financing of the National Health System is made possible through selective and non-indiscriminate funding taking into account general, objective and published criteria and, in particular, following:

a) Severity, duration and sequelae of the different pathologies for which they are indicated.

b) Specific needs of certain collectives.

c) Therapeutic and social value of the drug and incremental clinical benefit of the drug taking into account its cost-effectiveness.

d) Rationalization of public expenditure for pharmaceutical provision and budgetary impact in the National Health System.

e) Existence of medicinal products or other therapeutic alternatives for the same conditions at lower price or lower cost of treatment.

f) Degree of product innovation.

Without prejudice to the provisions of Article 24, and in order to ensure the rational use of medicinal products and medical devices, the Ministry of Health, Social Services and Equality may subject the specific conditions for the prescription, dispensing and financing of the same in the National Health System, ex officio or on a proposal from the Autonomous Communities in the Permanent Commission of Pharmacy of the Interterritorial Council of the System National of Health.

In order to guarantee the right of all persons enjoying the status of insured and beneficiary in the System of access to the pharmaceutical provision in conditions of equality throughout the National Health System, Autonomous communities may not, unilaterally, establish specific specific reservations for the prescription, dispensing and financing of medicinal products or medical devices.

However, within the Standing Committee of Pharmacy of the Interterritorial Council of the National Health System, the exception of one or more autonomous communities may be decided by reason of their own particularities.

2. The Ministry of Health, Social Services and Equality shall review the groups, sub-groups, categories and/or classes of medicinal products whose funding is not deemed necessary to meet the basic health needs of the Spanish population. In any event, medicinal products not subject to medical prescription, medicinal products which are not used for the treatment of a clearly determined pathology, or cosmetic products, dietetic products, shall not be included in the pharmaceutical supply. mineral waters, elixirs, toothpaste and other similar products.

Neither will be financed the medications indicated in the treatment of syndromes and/or symptoms of minor severity, nor those that, even having been authorized according to the current regulations, do not respond to the current therapeutic needs, with an understanding of an adverse benefit/risk balance in the diseases for which they are indicated.

3. The decision to exclude, in whole or in part, or subject to special financing conditions, the medicinal products already included in the pharmaceutical provision of the National Health System, shall be made with the criteria laid down in the taking into account the price or the cost of the treatment of comparable drugs on the market and the guidelines of the Interterritorial Council of the National Health System.

4. The equivalent shall be carried out in the case of medical devices to be included in the pharmaceutical provision of the National Health System and which are dispensed, through official prescription, on national territory.

5. The Government shall periodically review and update the relationship of medicinal products and medical devices included in the pharmaceutical provision of the National Health System, in accordance with the evolution of the criteria for rational use, scientific knowledge, the emergence of new medicinal products of greater therapeutic use or the occurrence of adverse effects which will vary the benefit/risk ratio and the criteria included in the preceding paragraphs.

6. The medical devices that are to be included in the pharmaceutical provision of the National Health System and that are dispensed, through official prescription, in national territory, will follow the criteria indicated for the drugs. In any event, they must comply with the specifications and technical specifications which the Ministry of Health, Social Services and Equality has previously determined, taking into account general, objective and published criteria and The following concrete:

a) Severity, duration and sequelae of the different pathologies for which they are indicated.

b) Specific needs of certain collectives.

c) Diagnostic, control, treatment, prevention, relief, or compensation for a disability.

d) Social value of the healthcare product and incremental clinical benefit of the product taking into account its cost-effectiveness.

e) Existence of medical devices or other therapeutic alternatives for the same conditions at lower price or lower cost of treatment.

7. The procedure for the incorporation into the pharmaceutical provision of the National Health System of medicinal products which, as provided for in Article 14, shall be carried out by the acronym EFG on the basis of their interchangeability shall be developed.

8. For the financing of new medicines, in addition to the corresponding cost-effectiveness and budgetary impact analysis, the innovation component will be taken into account, for indisputable therapeutic advances to change the course of the disease or improve the course of the disease, the prognosis and the therapeutic outcome of the intervention and its contribution to the sustainability of the National Health System if, for the same result in health, it contributes positively to the product Gross domestic.

Article 93. Exclusion from the pharmaceutical provision of medicinal products and medical devices.

1. The body responsible for the pharmaceutical provision of the Ministry of Health, Social Services and Equality shall, by means of a reasoned decision, update the list of medicinal products excluded from the pharmaceutical supply in the National System of Health.

2. The reason for the exclusion will respond to any of the following criteria:

a) The set of selected prices.

b) Cohabitation with a medication not subject to medical prescription with which you share active substance and dose.

c) The consideration of the medicinal product as likely to be advertised directly to the public in the European Union.

d) That the active principle has a favorable and sufficiently documented safety and efficacy profile through years of experience and extensive use.

e) By being indicated in the treatment of minor symptoms.

f) To meet any of the criteria for non-inclusion in public funding set out in Article 92.2.

3. Those responsible for the products excluded from the financing shall inform the competent authority of the prices to which they are to market such medicinal products. The same obligation extends to variations in prices.

4. In the month following the entry into the register of the competent authority of the communications referred to in the preceding paragraph, the latter shall decide whether or not the proposed prices are to be agreed. In the event of disagreement, that body shall raise the discrepancy to the Inter-Ministerial Committee for the Prices of Medicinal Products, which shall decide on the matter. That decision shall be notified by decision of the competent body to the person concerned.

The administrative decision referred to in the preceding paragraph shall be based on reasons for the protection of public health, equal access to medicinal products by patients or for actual or potential injury to the interests of the disadvantaged groups.

5. As soon as the disagreement referred to in the previous paragraph is maintained, the maximum industrial price shall be maintained.

Article 94. Pricing.

1. It is up to the Government to lay down the criteria and procedure for fixing the prices of medicines and health products financed by the National Health System, both for the supply of medicines by office of pharmacy to through an official prescription, such as for hospital-level drugs, including clinical packaging, or dispensed by pharmacy services to unadmitted patients.

The return mechanisms (linear discounts, price revision) for innovative medicines will be considered.

The Inter-Ministerial Committee on Drug Prices will take into consideration the cost-effectiveness and budgetary impact analyses.

2. For the marketing of a medicine in Spanish territory it will be necessary to have processed the offer of the same to the National Health System. In the same way, there will be substantial variations in the conditions of authorisation of the medicinal product.

3. The Government may regulate the mechanism for the pricing of medicinal products and medical devices not subject to medical prescription that are dispensed in Spanish territory, following a general objective and transparent regime.

4. In any event, the holders of marketing authorisations for the same may place on the market the medicinal products that are dispensed in Spanish territory under the notified price system, thereby understanding the price communication to the Ministry. of Health, Social Services and Equality, so that the department may object to it for reasons of public interest.

5. It is for the Interministerial Commission for the Prices of Medicinal Products, attached to the Ministry of Health, Social Services and Equality, to fix, in a reasoned and objective manner, the financing prices of the National System of Health of medicinal products and medical devices for which medical prescription is required, to be dispensed in Spanish territory. Where the same products are not financed, if they are dispensed in national territory, they shall operate as set out in paragraph 4.

6. In any case, the medicines and medical devices that are decided to be financed by the National Health System may also be placed on the market for prescription.

7. As a general rule, the financing price for the National Health System will be lower than the industrial price of the drug applied when it is dispensed outside the National Health System. Pharmaceutical laboratories, distribution entities and pharmacy offices through the Collegial Pharmaceutical Organization must provide the information to be determined to make the reimbursement effective due to the pharmacy offices. pharmaceutical laboratories and distribution entities in those medicines that are established and that have been dispensed outside the National Health System. The procedure for their articulation shall be developed regulatively.

8. For decision-making, the Interministerial Drug Price Commission will take into consideration the reports that the Advisory Committee for Financing the Pharmaceutical Delivery of the National Health System will make.

9. The economic amounts corresponding to the concepts of the distribution and dispensing of the medicinal products and the medical devices and, where appropriate, the deductions applicable to the billing of the same to the National Health System will be established by the Government, with the agreement of the Government Delegation for Economic Affairs, in general or by groups or sectors, taking into consideration criteria of a technical and economic nature.

10. The Ministry of Health, Social Services and Equality shall establish the selling price to the public of the medicinal products and medical devices financed by the aggregation of the authorised industrial price, which is of a maximum nature, and of the margins corresponding to the wholesale distribution and distribution activities to the public.

Article 95. From the Advisory Committee for the Financing of the Pharmaceutical Delivery of the National Health System.

1. The Advisory Committee for the Financing of the Pharmaceutical Delivery of the National Health System is the collegiate body, of a scientific-technical nature, attached to the competent ministerial body in the field of pharmaceutical provision of the Ministry of Health Health, Social Services and Equality, which is responsible for providing advice, assessment and consultation on the relevance, improvement and monitoring of the economic assessment needed to support the decisions of the Inter-Ministerial Price Commission of the Medicines.

2. The Advisory Committee for the Financing of the Pharmaceutical Delivery of the National Health System shall be composed of a maximum number of seven members appointed by the head of the Ministry of Health, Social Services and Equality, from professionals of recognized prestige, with experience and proven track record in pharmaco-economic assessment.

3. In addition, on the basis of the issues to be discussed, the evaluators of the competent body in the field of medicinal products and medical devices which have drawn up the evaluations of medicinal products and products may attend the meetings of the Committee. health issues to be discussed.

4. In any case, the creation and functioning of the Advisory Committee for the Financing of the Pharmaceutical Delivery of the National Health System will be addressed with the personal, technical and budgetary resources assigned to the body to which it is located. attached.

Article 96. Price revision.

1. The price fixed in accordance with Article 94 shall be reviewed ex officio or at the request of a party in accordance with the provisions of Articles 102 et seq. of Law 30/1992 of 26 November 1992 on the legal system of administrations Public and the Common Administrative Procedure.

2. Outside of the assumptions provided for in the previous paragraph, the price of a medicinal product may be modified where changes are required in the economic, technical, health or in the assessment of its therapeutic use.

3. The Council of Ministers, after agreement of the Government Delegation for Economic Affairs, may review overall or fix the conditions for periodic review of industrial prices or, where appropriate, of the sale prices to the public, for all or part of the medicines and medical devices included in the pharmaceutical provision of the National Health System.

4. It is also up to the Council of Ministers, after agreement of the Government's Delegation for Economic Affairs, to review the economic amounts corresponding to the distribution and supply of medicines and products. health.

5. Medicinal products excluded from financing from public funds and which have indications not excluded from it shall be considered to be financed by those funds for the purposes of fixing and reviewing their intervention price.

6. For the purposes of the revision of the prices referred to in paragraph 1 below, account shall be taken only of those which represent at least a 10% reduction in the maximum industrial price in force authorised for the financing of the with public funds.

Article 97. Economic information.

1. For the purposes of price fixing, pharmaceutical laboratories shall provide the Ministry of Health, Social Services and Equality with all information on the technical, economic and financial aspects. The Ministry may carry out checks on the information provided.

2. In the event that the company is integrated into a group carrying out other activities, in addition to those related to medicines, or develops them outside Spain, the Ministry of Health, Social Services and Equality may require the information which allows the imputation to be known in order to determine the costs involved in the pharmaceutical activity in Spain.

3. The information provided by this article will be kept confidential by the General Administration of the State.

4. The Ministry of Health, Social Services and Equality will annually raise a report on its pricing actions to the Government's Delegation for Economic Affairs.

Article 98. Reference price system.

1. Public funding for medicinal products will be subject to the reference price system. The reference price shall be the maximum amount by which the presentations of medicinal products included in each of the sets to be determined shall be financed, provided that they are prescribed and dispensed with public funds.

2. The assemblies shall include all the presentations of medicinal products financed which have the same active substance and the same route of administration, including in the pharmaceutical supply of the National Health System, at least one presentation of a generic or biosimilar medicinal product, unless the medicinal product or its main active ingredient has been authorised at least ten years in advance in a Member State of the European Union, in which case the the existence of a generic or biosimilar medicinal product to establish a set. The presentations indicated for treatments in pediatrics, as well as those for medicinal products in the hospital, including clinical packaging, shall constitute separate sets.

3. The reference price for each set will be calculated on the basis of the lower cost/treatment/day of the presentations of medicinal products in the grouped and, in any case, the supply to the pharmacy offices for the medicinal products of the lower price. Medicinal products may not exceed the reference price of the whole to which they belong.

4. The new sets will be established and the prices of the existing sets will be revised on an annual basis. However, the lower prices of the new homogeneous groupings will be automatically fixed in the corresponding Nomenclator, and the lower prices of the existing ones will be revised on a quarterly basis.

5. The Ministry of Health, Social Services and Equality shall establish a similar system of prices for medical devices.

Article 99. Selected pricing system.

1. The Ministry of Health, Social Services and Equality may propose to the Inter-Ministerial Commission for Drug Prices the application of the selected price system to financial medicines and medical devices.

2. To this end, the Ministry of Health, Social Services and Equality shall draw up a reasoned proposal, in accordance with the criteria set out in this Article, which shall contain the maximum price selected for each case.

3. Once authorised by the Inter-Ministerial Committee for the Prices of Medicinal Products, the Ministry of Health, Social Services and Equality shall publish the decision by resolution of the unit responsible for the pharmaceutical supply.

4. In the case of medicinal products financed, the price system selected shall apply to medicinal products subject to reference prices, taking into account:

a) The consumption of the set.

b) The budgetary impact.

c) The existence of at least three drugs in the set.

d) No shortage of risk.

5. For the case of medical devices similar criteria shall apply.

6. Having regard to the above criteria, the Ministry of Health, Social Services and Equality, through the competent body in the field of pharmaceutical supply, shall inform suppliers of the initiation of a price procedure. selected, with communication of the maximum funding price that is proposed to manifest their intentions.

7. On the basis of the communications received, the Ministry of Health, Social Services and Equality shall draw up the proposal referred to in paragraph 2.

8. Those medicines and/or medical devices that exceed the maximum eligible price will be excluded from funding by the National Health System.

9. The price selected shall be valid for two years during which it may not be modified.

10. The price system selected shall be updated, for cases where it has not been previously applied, on an annual basis, at the same time as the reference price system update.

11. The application of this system will result in the exclusion of public funding from those presentations that are not selected, for the duration of the selected price.

12. In any event, the presentations of the medicinal products that are affected by the provisions of this Article shall be exempt from the application of the deductions provided for in Articles 8, 9 and 10 of the Royal Decree-Law. 8/2010, of 20 May, adopting extraordinary measures for the reduction of the public deficit.

13. The laboratories holding the marketing authorization for the presentations of the medicinal products and the companies offering the presentations of the medical devices that will be finally selected will have to assume the commitment of ensure adequate supply by express declaration to the effect.

14. The selected price system may be applied to medicinal products and medical devices which, not being financed, are considered to be of interest to public health in the terms expressed in Law 33/2011 of 4 October, General Health Public.

15. In this respect, the Ministry of Health, Social Services and Equality for the determination of the price selected shall take into account the special characteristics of distribution and application of these products.

16. In addition, the selected price system may be extended through the fixing of a reduced contribution by homogeneous groupings.

Article 100. Promotion of competition and competitiveness.

1. For the purpose of the efficiency and sustainability of the pharmaceutical delivery of the National Health System, the administrative and regulatory measures that are considered appropriate for each financial year will be implemented. to stimulate competition between suppliers of pharmaceutical inputs, resulting in unit price decreases.

2. Any limitation of competition shall be deemed to be contrary to the principles of efficiency and sustainability and shall be pursued by the competent bodies.

Article 101. Patients ' obligations.

1. The Government shall periodically review the participation in the payment to be paid by the citizens for the pharmaceutical provision included in the supplementary common portfolio of the National Health System, and the financing assumptions shall be public funds.

The review will be published in the "Official State Gazette" by order of the person holding the Ministry of Health, Social Services and Equality.

2. The participation in the payment may be modulated by the Government with criteria that take into account:

a) The ability to pay.

b) The therapeutic and social usefulness of medicines or medical devices.

c) The specific needs of certain collectives.

d) The severity, duration, and sequelae of the different pathologies for which they are indicated.

e) Rationalization of public expenditure for pharmaceutical provision.

f) Existence of medicines or medical devices already available and other alternatives better or equal for the same conditions.

3. Users will be required to justify their right to the corresponding payment method when required by the medical staff of the National Health System or the dispensing pharmacy offices.

Article 102. Contribution of users and their beneficiaries in the outpatient pharmaceutical provision.

1. It is understood by means of outpatient pharmaceutical provision that the patient is dispensed by a medical prescription or order of hospital dispensation, through offices or pharmacy services.

2. The outpatient pharmaceutical provision shall be subject to the user's input.

3. The user's contribution shall be made at the time of dispensing of the medicinal product or medical device.

4. The user's contribution shall be proportional to the level of income that shall be updated annually.

5. In general, the percentage of user input will follow the following schema:

(a) 60% of the PVP for users and their beneficiaries whose income is equal to or greater than EUR 100 000 entered in the general liquidable base box and the saving of the Income Tax declaration Physical.

(b) 50% of the PVP for persons holding the status of an insured person and their beneficiaries whose income is equal to or greater than EUR 18 000 and less than EUR 100 000 entered in the general liquidable base box and the saving of the Income Tax declaration of the Physical Persons.

(c) 40% of the PVP for persons who have the status of an active insured person and their beneficiaries and are not included in paragraphs (a) or (b) above.

(d) 10% of the PVP for persons who have the status of insured persons as Social Security Pensioners and their beneficiaries, with the exception of the persons referred to in paragraph (a).

6. In order to ensure the continuity of treatments of a chronic nature and to ensure a high level of equity for pensioners with long-term treatment, the overall percentages will be subject to maximum contribution ceilings. in the following assumptions:

(a) 10% of the PVP in medicinal products belonging to the reduced-contribution ATC groups, with a maximum contribution of EUR 4,24.

(b) For persons holding the status of insured persons as Social Security pensioners and their beneficiaries whose income is less than EUR 18,000 entered in the general liquidable base box and the saving of the a statement of the Income Tax of the Physical Persons or not included in the following paragraphs (c) or (d), up to a maximum monthly contribution limit of EUR 8,23.

(c) For persons holding the status of insured persons as Social Security pensioners and their beneficiaries whose income is equal to or greater than EUR 18,000 and less than EUR 100 000 entered in the basic box general liquidable and saving the income tax return of the physical persons, up to a maximum monthly contribution limit of 18.52 euros.

(d) For persons holding the status of insured as a pensioner of Social Security and their beneficiaries whose income exceeds EUR 100 000 entered in the general liquidable base box and the saving of the Tax on the Income Tax of the Physical Persons, up to a maximum monthly contribution limit of EUR 61.75.

7. The amount of contributions exceeding the amounts referred to in the previous paragraph shall be reimbursed by the corresponding autonomous community at a maximum of six-monthly intervals.

8. Users and their beneficiaries who belong to one of the following categories shall be exempt from contributions:

(a) Affected by toxic syndrome and persons with disabilities in the cases referred to in their specific legislation.

b) Persons who are recipients of social integration income.

c) Non-contributory pension recipients.

(d) Parados who have lost the right to receive unemployment benefit as long as their situation is subsisting.

e) Persons with treatments resulting from accidents at work and occupational disease.

9. The level of contribution of the persons surveyed in the General Mutuality of Civil Servants of the State, the Social Institute of the Armed Forces and the General Judicial Mutuality will be of 30% in general, resulting in the application of the referred to in subparagraph (a) of paragraph 6 and in paragraph 8 (e).

Article 103. Protection of personal data.

1. The National Social Security Institute or, where appropriate, the Social Institute of the Navy may treat the data in the files of the management entities and common services of Social Security and of the entities that collaborate with the which are essential for determining the amount of the beneficiaries ' contribution to the pharmaceutical supply. Such treatment, which shall not require the consent of the person concerned, shall be fully subject to the provisions of the Organic Law 15/1999 of 13 December and its provisions for development.

2. Similarly, and for the purpose referred to in the preceding paragraph, the competent authority in the field of taxation may communicate to the National Institute of Social Security or, where appropriate, to the Social Institute of the Navy, without having the consent of the data subject, the data necessary to determine the level of income required.

Likewise, the bodies of public administrations which are competent to determine the concurrency of the requirements laid down for exemption from the contribution provided for in Article 102.8 may communicate this circumstance to the National Institute of Social Security or, where appropriate, to the Social Institute of the Navy without the consent of the person concerned.

3. The National Institute of Social Security or, where appropriate, the Social Institute of the Navy shall communicate to the Ministry of Health, Social Services and Equality and, in turn, to the other competent health administrations the data relating to the the level of input that corresponds to each user in accordance with the rules of the medical prescriptions and dispensing orders. In no case shall such information include the actual amount of the income.

The data communicated in accordance with the provisions of the preceding paragraph shall be treated by the health administration concerned with the sole effects of its incorporation into the information system of the card individual health.

Article 104. Assessment of the prescription.

1. In the field of the National Health System, it is up to the public health authorities to evaluate the prescriptions for areas, zones, therapies, population groups, and other circumstances.

2. The Ministry of Health, Social Services and Equality shall establish coordination mechanisms to enable the use of medicinal products and medical devices to be used, to optimise research into their development and to take the necessary information and the promotion of the rational use of medicinal products and medical devices and, where appropriate, the precautionary and control measures corresponding to the requirement of administrative and criminal responsibilities to be carried out.

Article 105. Collaboration between pharmacy offices and the National Health System.

1. Pharmacy offices, such as healthcare facilities, will collaborate for the purposes of this law to ensure the rational use of drugs in primary health care.

2. Regardless of the obligations laid down in this law and those laid down in the implementing legislation, the pharmacy offices may be the subject of consultation in the National Health System, in accordance with the general system of administrative procurement and in accordance with the general criteria referred to in Article 92.6.

Article 106. Information management on the pharmaceutical delivery of the National Health System.

1. In order to implement the actions necessary for the assessment of the prescription and of the general pharmaceutical policy, the competent public authorities shall provide the aggregated or disaggregated information concerning the consumption of medicinal products. by prescription and at the level of hospital facilities and any other areas within the pharmaceutical provision of the National Health System. At least, this information will be presented on a monthly basis; it will be provided from the Ministry of Health, Social Services and Equality, which will carry out the aggregation and treatment of the before making it public.

2. The aggregated information resulting from the processing of the prescriptions of the National Health System, including those of the Mutuality of Civil Servants of the State, the General Judicial Mutuality and the Social Institute of The Armed Forces, is in the public domain, always saving the confidentiality of health care and the commercial data of individual companies. Its management corresponds to the Health Services of the Autonomous Communities in its territorial scope and to the General Administration of the State in the information of the National Health System.

The provisions of the preceding paragraph shall also apply to information relating to purchases of medicinal products and medical devices carried out through the corresponding pharmacy services by hospitals. of the National Health System.

3. The aggregated information resulting from the processing of the prescriptions referred to in the previous paragraph shall be processed and transmitted in electronic form by the bodies responsible for the processing.

The government, by means of royal decree, will establish the procedure for the referral of the information to the administrations responsible for the management of the pharmaceutical supply in a way that allows to apply to the monthly invoice of each Pharmacy office, for prescriptions of medicinal products for human use manufactured industrially from public funds of the Autonomous Communities and the National Institute of Health Management, MUFACE, ISFAS and MUGEJU, a joint scale of deduction on the applicable margins.

4. The information referred to in this Article shall be provided on a monthly basis and shall be for a period not exceeding three months immediately prior to the date on which it is provided.

Article 107. Fundamentals of the information systems for the control of the pharmaceutical supply.

1. The State's intervention in the field of medicinal products and medical devices financed by the National Health System requires the full provision of solid information on the consumption of the sanitary inputs covered by this information. To this end, both the Ministry of Health, Social Services and Equality and the competent authorities of the Autonomous Communities and, where appropriate, the supplying companies and their professional representative bodies, will provide the following information regarding the traffic and consumption of the same:

a) National Health System official prescription billing data on a monthly basis, dispensed by pharmacy offices and aggregated by province and autonomous community.

(b) Data on acquisitions by pharmaceutical services of health or social health centres and services of the National Health System and, where appropriate, fertilizers of medicinal products and medical devices, at least on a monthly basis; and with aggregation level by province and Autonomous Community.

2. The General Mutuality of Civil Servants of the State, the General Judicial Mutuality and the Social Institute of the Armed Forces will provide the same type of information, with the exception of the care modalities that are own.

3. Medicinal products dispensed by pharmaceutical services from healthcare or social healthcare facilities or healthcare providers from the National Health System to outpatients will be collected in a specific computer application.

4. The computerised treatment referred to in the preceding paragraph may be extended to other medicinal products and medical devices for the exclusive use of hospitals to which the Inter-Ministerial Committee on the Prices of Medicinal Products considers appropriate. apply a system of unique caufabrics.

TITLE IX

Sanctioning Regime

CHAPTER I

Inspection and precautionary measures

Article 108. Inspection.

1. It is up to the health authorities in the field of their competence to carry out the necessary inspections to ensure compliance with the provisions of this law.

2. It is for the General Administration of the State to carry out the inspection function in the following cases:

(a) In the case of the necessary actions for the appropriate authorizations or records which, according to this law, correspond to the General Administration of the State.

(b) In any event, in the case of inspections to be carried out in the territory of the autonomous communities which do not have powers of implementation of the legislation of pharmaceutical products or have not received the corresponding transfers.

(c) In the case of medicinal products, products or articles intended for external trade or the use or consumption of which may affect public safety.

3. Personnel serving the public administrations who carry out the inspection functions, when exercising such functions and certifying their identity, shall be authorised to:

(a) To enter freely and without prior notification, at any time, in any center or establishment subject to this law.

b) Proceed with the necessary tests, investigations, or examinations to check compliance with this law and the rules that are required for its development.

c) Take or take samples, in order to check compliance with the provisions of this law and the provisions for its development.

d) Perform as many performances as accurate in order to fulfill the inspection functions they develop.

Article 109. Precautionary measures.

1. In the event that there is or is reasonably suspected imminent and serious health risk, the health authorities may take the following precautionary measures in the field of this law:

(a) Quarantine, withdrawal from the market and prohibition of the use of medicinal products, formal formulae and official preparations, as well as the suspension of activities, advertising and the provisional closure of establishments, centres or services.

The quarantine shall mean the immediate blockade of the pharmaceutical establishment in which they are located or to which they are intended, in the case of transport not completed, for the time to be determined or until new order, in charge of their responsible.

(b) Suspension of the preparation, prescribing, dispensing and supply of investigational medicinal products and medical devices.

c) The limitation, prohibition, suspension or subjection to special conditions of manufacture, import, marketing, export, advertising, putting into service or use of medical devices, cosmetics or personal care products, as well as quarantine, withdrawal from the market and recovery of such products.

2. The duration of the measures referred to in the preceding paragraph, which shall be fixed for each case, without prejudice to successive extensions agreed upon by reasoned decisions, shall not exceed what is required by the situation of imminent and serious risk which the justified.

3. The Spanish Agency for Medicinal Products and Health Products shall be informed immediately by the health authority which adopted the precautionary measure.

4. Of the precautionary measures the Spanish Agency for Medicines and Health Products will give knowledge by means of appropriate means and with the appropriate speed to each case, to the health services, responsible entities or general public, according to proceed.

5. The cost of the precautionary measures shall be borne by the natural or legal person who has given rise to their adoption.

CHAPTER II

Violations and penalties

Article 110. General provisions.

1. Infringements in the field of medicinal products, medical devices, cosmetics and personal care products shall be subject to the appropriate administrative penalties, subject to the instruction of the appropriate file, without prejudice to the civil, criminal or other order responsibilities that may be present.

2. The criminal proceedings before the Courts of Justice shall suspend the processing of the administrative file of penalties which has been initiated by the same facts and, where appropriate, the effectiveness of the administrative acts of taxation of sanction. The administrative measures that would have been taken to safeguard the health and safety of persons shall be maintained as long as the judicial authority decides on them.

3. In no case shall a double sanction be imposed for the same facts and on the basis of the same protected public interests, but other responsibilities which are deducted from other events or concurrent infringements shall be required.

4. With respect to the sanctioning regime and as not provided for by this law, the provisions of Title IX of Law 30/1992 of 26 November 1992 shall apply.

Article 111. Infringements in the field of medicinal products.

1. The infringements are considered to be minor, serious and very serious in the light of the health risk criteria, the amount of the possible benefit obtained, the seriousness of the health and social change produced, the generalisation of the infringement and recidivism.

2. They shall constitute administrative misconduct and shall be sanctioned in accordance with the terms of Article 114, the following offences:

a) Mild infractions:

1. No contributing, the entities or persons responsible, the data, statements as well as any information that they are required to supply for health, technical, economic, administrative and financial reasons.

2. Inaccomplish the duty to collaborate with the health administration in the evaluation and control of medications.

3. Do not dispose, the establishments obliged to do so, of access to the Spanish Royal Pharmacopoeia and to the National Form.

4. Unprovide, pharmaceutical laboratories, to the health doctors in exercise who request it for the technical information sheet before they are placed on the market.

5. Conduct advertising of master formulas or official preparations.

6. Incompliance with the requirements for the medical visit, establish the regulations of the competent health administrations in the management of the pharmaceutical provision.

7. Do not correctly fill in the data and warnings that should contain the normalized recipes.

8. Dispense Medications after the prescription is valid.

9. Perform the replacement of a drug, in cases where possible, in breach of the requirements set out in this law.

10. Incompliance with the requirements, obligations or prohibitions laid down in this law and provisions that develop it in such a way that, on the basis of the criteria referred to in this Article, such non-compliances The rating of a minor or not as a serious or very serious fault.

11. Do not include in the packaging of medicines the information in the alphabet braille for correct identification by blind and visually impaired persons, in accordance with the provisions of Article 15 (5).

b) Serious infractions:

1. Not to be carried out in the manufacture, manufacture, import, export and distribution of medicinal products or active substances, the quality controls required in health legislation or to comply with the detailed guidelines on rules of correct manufacturing or good distribution practices established within the Community framework or to carry out manufacturing or control processes by means of non-validated procedures.

2. Develop, manufacture, import, export, dispense or distribute medicinal products by natural or legal persons who do not have the required authorization.

3. ª hinder the inspector's work by any action or omission that disturbs or delays the work.

4. Individually Prepare Vaccines and allergens in establishments other than those authorized.

5. Prescribe and prepare official formulas and formal preparations in violation of established legal requirements.

6. th Modify by the holder, without prior authorization or notification, as appropriate, any of the conditions of authorization of the medicinal product.

7. No avail, a pharmaceutical laboratory or distribution entity, technical director or other staff required in each case.

8. Incompliance, the technical director and other personnel, the obligations that are relevant to your charges.

9. Incompliance, the sponsor or investigator of a clinical trial, the obligations established for each of them in the legislation in force, where the fact of the criteria referred to in this article does not merit the rating of very serious.

10. Incompliance, the clinical trial promoter, the deadlines for communication to the health authorities of serious and unexpected adverse reactions occurring in a clinical trial.

11. Facilitate, To The Ethical Committee of Clinical Research or to the health authorities, information and/or documentation, related to a clinical trial, not truthful or that results in inaccurate conclusions.

12. Incompliance, the sponsor, the obligation to publish the results of a clinical trial as set out in Article 62.

13. Act, the members of the Ethical Committee of Clinical Research, without adjusting to the legally established operating requirements or without being properly accredited.

14. Incompliance, pharmaceutical laboratories, distribution entities or health personnel, the duty of pharmacovigilance.

15. Refuse to dispense medication without justified cause.

16. Dispense Medications not subject to medical prescription, when required.

17. To supply, acquire or sell medicinal products to entities that are not authorized to carry out such activities.

18. Act, health professionals involved in the cycle of prescription, dispensing and administration, and whenever they are in exercise, acting as a medical visit, representatives, commission or agents Drug laboratories informers.

19. Incompliance, health personnel, the duty to ensure the confidentiality and privacy of patients in the processing of prescriptions and medical orders.

20. It will work, pharmacy services and pharmacy offices, without the presence and professional performance of the responsible pharmacist.

21. Incompliance, the pharmacy offices, the requirements that the billing to the National Health System of the products referred to in this law.

22. ª Defraud, the pharmacy offices, the National Health System or the beneficiary of the same, for the purpose of billing and collection of official prescriptions.

23. Dispense Medications in establishments other than authorized ones.

24. Do not adjust the drug prices to what is determined by the Administration.

25. Replace Medication in the dispensation, contravening the provisions of Article 89.

26. Cough the freedom of the user in the choice of the pharmacy office by any act or omission.

27. Offer directly or indirectly any incentive, bonus, prohibited discounts, premiums or gifts, made by those who have direct or indirect interests in the production, manufacture and marketing medicines, to healthcare professionals, on the occasion of the prescription, dispensing and administration of the same, or to their relatives and people of their coexistence.

28. Accept, healthcare professionals, on the occasion of the prescription, dispensing and administration of medications from the National Health System, or their relatives and persons from their coexistence, any type of incentive, bonuses, prohibited discounts, premiums or gifts made by those who have direct or indirect interests in the production, manufacture and marketing of medicinal products.

29. Do not communicate pharmaceutical laboratories to the Ministry of Health, Social Services and Equality units of drugs sold to be dispensed on national territory.

30. Inform distribution entities to the health authorities of the autonomous communities in which they have their registered office and to the Ministry of Health, Social Services and Equality, of the units provided to pharmacy or pharmacy services which radiate on national territory, as well as, where appropriate, to other distribution entities, irrespective of the Autonomous Community in which the latter radiate.

31. Uncommunicate the pharmacy offices the information on dispensed medications referred to in this law.

32. '32.' To carry or hide responsible entities or persons, data, statements or any information which are required to supply competent health administrations in such a way as to be neither truthful or likely to result in inaccurate conclusions, in order to obtain any benefit, whether economic or otherwise.

33. Incompliance, persons engaged in medication intermediation, requirements established in current regulations, and good drug distribution practices.

34. Incompliance, the manufacturer of the medicinal products, the obligations on excipients used in the manufacture of medicinal products.

35. Perform, by the holder of the laboratory authorization or the holder of a distribution authorization, activities that do not conform to it.

36. Incompliance, pharmacy offices and pharmacy services, legally established in the field of user input in the pharmaceutical provision of the National Health System.

37. Perform the pharmacy office any act that induces the user to acquire a greater quantity of medications within the pharmaceutical delivery of the National Health System than the truly necessary or demanded by the latter.

c) Very severe infractions:

1. Place medicines of any kind on the market without having obtained the prescriptive health authorization for this.

2. Make, import, export, broker, distribute, dispense and sell counterfeit medicines. This infringement will also apply in the event that this sale is carried out at a distance.

3. Incompliance, the holder of the authorization, the obligation to submit periodic safety reports

4. Prepare secret remedies.

5. Import and export blood, fluids, glands and human tissues and their components and derivatives without prior authorization.

6. Perform clinical trials without prior administrative authorization.

7. Conduct clinical trials without the consent of the subject of the trial or, where appropriate, of its legal representative, or the investigator's failure to comply with the duty of information on the clinical trial to whom participates as the subject of the same.

8. Uncommunicate, the sponsor of a clinical trial, the health authorities adverse reactions occurring in the development of the clinical trial or periodic safety reports.

9. Incompliance, the sponsor or investigator of a clinical trial, the obligations established for each of them in the legislation in force when it is detrimental to the rights, safety and welfare of the subjects.

10. Distribute or keep the medicines without observing the conditions required, as well as put on sale altered medicines, in poor conditions or, when the time has been stated, the term of validity.

11. Vender medicines at home or through the Internet or other telematic or indirect means, contrary to the provisions of this law or in breach of the provisions governing such sale.

12. Incompliance with distribution entities and pharmacy offices with their legal obligations, and in particular not disposing of stocks of medicinal products suitable for the normal provision of their activities or services.

13. Incompliance of distribution entities and pharmacy offices with their legal obligations, and in particular not having minimum stocks of medicinal products for emergency or disaster situations, in cases that result required.

14. To develop, manufacture, import, export, distribute, market, prescribe and dispense products, preparations, substances or combinations thereof, which are presented as medicinal products without being legally recognized as such.

15. Incompliance with the obligation to take out insurance, guarantee or equivalent financial guarantee in the cases required by this law.

16. Conduct promotion, information or advertising of unauthorised medicinal products or without such activities being in accordance with the provisions of this law or in the general legislation on advertising.

17. To carry out promotion, publicity or information intended for the public of products or preparations, for medicinal purposes, even if the product itself does not explicitly refer to such purposes, including medicinal substances and their combinations, which are not authorised as medicinal products.

18. th Offer premiums, gifts, prizes, contests, bonuses, discounts or similar as methods linked to the promotion or sale to the public of the products regulated in this law.

19. Incompliance with the precautionary and definitive measures on medicinal products to be agreed by the competent health authorities for serious public health reasons.

20. No to the requirements and conditions governing the advertising and commercial promotion of the products, materials, substances, energies or methods to which beneficial effects on the health.

21. Cesar the supply of a medicinal product by the marketing authorisation holder, in the case where health reasons or health concerns are present, as in the case of originating therapeutic lagoon, either in the market in general or in the pharmaceutical provision of the National Health System.

22. Distribute Outside the national territory medicines for which there are problems of lack of supply with a health impact.

23. Perform, by pharmacy offices, drug distribution activities to other pharmacy offices, authorized distribution entities, or other entities, centers or individuals without authorization to the activity of distribution or the carrying out of consignments of medicinal products outside the national territory.

24. Dispense, sell or market the medicines returned or delivered by patients or the general public to the pharmacy offices.

25. Incompliance, the holder of the marketing authorisation, its obligation to have sufficient supply of the market, in an appropriate and continuous manner to enable compliance with the legally established requirements in the field of pharmaceutical provision of the National Health System and guarantee the supply to the pharmacy offices and pharmacy services of the medicinal products included in homogeneous, lower-priced and lower-priced pools.

26. Masking for the performance of duly accredited inspectors, in the centres where medicinal products are manufactured, manufactured, distributed and dispensed.

3. The commission of an infringement, preceded by two other immediately lower or equal penalties on the firm within one year before that commission, shall increase from a minor to serious, or from serious to very serious, such an infringement.

Article 112. Infringements in the field of medical devices.

1. The infringements are considered to be minor, serious and very serious in the light of the health risk criteria, the amount of the possible benefit obtained, the seriousness of the health and social change produced, the generalisation of the infringement and recidivism.

2. They shall constitute administrative offences and shall be sanctioned in accordance with the terms of Article 114 of the following conduct:

a) Mild infractions:

1. No contributing, the entities or persons responsible, the data, statements, as well as any information that they are required to supply for health, technical, economic, administrative and financial reasons.

2. Incompliance with the duty to collaborate with health authorities in the assessment, surveillance and control of medical devices.

3. ª hinder the inspector's work by any action or omission that disturbs or delays the work.

4. To present at fairs, exhibitions and demonstrations products unfit for placing on the market or in service without the corresponding indication of their non-conformity or inability to put into service.

5. Do not keep the intended declaration for custom products at the disposal of the patient, do not inform the patient about it or not give it to them.

6. Unidentify as such products intended exclusively for export.

7. Incompliance with the requirements, obligations or prohibitions laid down in the applicable regulations which, on the basis of the criteria referred to in this Article, merit the rating of minor or where their qualification does not apply as serious or very serious faults.

b) Serious infractions:

1. Do not make it easier for the patient and/or not to include in his/her medical history the required information about the product he/she has received or the implantation card when it has been established, as well as not referring the card to the patient. the supplying undertaking or the national register which has been disposed of.

2. To manufacture, group and sterilize the products in national territory without the prior health license of the installation, as well as to import sanitary products without the prior authorization of establishment.

3. To manufacture, group, sterilize or import products without respecting the requirements or without complying with the conditions under which the operating license was granted.

4. Incompliance of the technical officer with the obligations of his or her position.

5. To market health products without "CE marking" when this is mandatory, to use any other marking that could lead to confusion with the "CE marking", as well as to place the "CE marking" on the products under conditions other than those laid down, except as provided for in point (c) of point (c) of this paragraph.

6. Not to keep at the disposal of the competent authorities and for the time indicated the required documentation, as well as to refuse to provide such documentation to the health authorities.

7. Infulfill the duty of marketing communication in the products in which such communication is required, as well as not to communicate the modifications produced or the cessation of the marketing.

8. Incompliance with the duty of communication of those responsible established in Spain when such communication is required as well as not communicating the modifications produced.

9. Incompliance with the manufacturer, authorised representative, importer or distributor of the obligations relating to the identification of the agents preceding or following them in the marketing chain.

10. Incompliance of the importer or the distributor with the obligations incumbent upon them to ensure that the products have followed the corresponding conformity assessment procedures and the documentation has been prepared mandatory.

11. Distribute or sell products on an outpatient basis or in establishments that have not been properly communicated or authorized, or who do not have the appropriate qualified professional or professional.

12. ª Distribute, install, maintain and use products without observing the required conditions, as well as put on sale altered sanitary products, in poor conditions or when the validity period has been exceeded.

13. Distribute implantable products without providing the corresponding implantation card when it is mandatory, as well as not giving the treatment due to such cards.

14. Vender to the public health products in cases not permitted, as well as without requiring the corresponding prescription when it is required, except as provided for in the infringement 7. of point (c) of this paragraph.

15. Conduct clinical investigations without complying with the intended procedures and conditions except as provided for in violations 8. and 9. of point (c) of this paragraph.

16. Incorrectly Execute the notified body of the actions that are entrusted to it without having any impact on the safety of the certified products.

17. Refusal to provide the notified body with the documentation requested by the Ministry of Health, Social Services and Equality to verify compliance with its requirements and obligations.

18. Incompliance of the manufacturer, authorized representative, importer or distributor the duty of notification of adverse incidents and safety actions to the Health Products Surveillance System, as well as to refuse to modify or suspend actions under the conditions required by the health authority.

19. Infulfill the duty of notification in the course of clinical investigations of the required circumstances.

20. To prevent the performance of duly accredited inspectors in the centres where they are manufactured, stored, distributed, sold or used.

21. Violate the principle of confidentiality in relation to the information of patients and products by whom they are obliged to maintain it.

22. Put into service in Spain products that do not include in the labelling and instructions for use the required data and information, at least in Spanish.

23. Incompliance with the requirements and conditions relating to the advertising and promotion of medical devices.

24. To effect advertising directed to the public of products in which it is not permitted, except as provided for in point (c) of paragraph 12 of this paragraph.

25. To offer, grant or promise premiums, pecuniary advantages or benefits in kind to healthcare professionals or any other qualified, related to the use or prescription of medical devices, as well as to their relatives and people of their coexistence. Also requesting or accepting them.

26. Use a professional product under conditions and for uses other than those indicated by the manufacturer, or by non-qualified or duly trained personnel.

27. Use in patients who have not satisfied the conformity assessment procedures that apply to them.

28. Refuse to dispense sanitary products without justified cause.

29. Act, health professionals involved in the cycle of prescription, dispensing and administration, and whenever they are in exercise, acting as a medical visit delegate, representatives, agents or agents reporting by the health product laboratories.

30. Manufacture Tailored Sanitary Products without the corresponding prescription written by an optional.

31. Incompliance with the health care professional with the duty to report adverse incidents to the Health Products Surveillance System.

32. Incompliance, pharmacy offices and pharmacy services, legally established in the field of user input in the pharmaceutical provision of the National Health System.

c) Very severe infractions:

1. Place on the market and/or in service products that do not meet the essential requirements that apply to them.

2. Place on the market and/or in service products which have not satisfied the conformity assessment procedures or which have not made the declarations which, if necessary, result from them being applied.

3. Third Marketers and/or put into service products that compromise the health or safety of patients, users or, where appropriate, third parties.

4. Install and/or maintain inadequately products, in such a way as to compromise the health or safety of patients, users or, where appropriate, third parties.

5. Improperly Use "CE marking" on non-conforming products or have not satisfied the corresponding conformity assessment procedures, as well as products that do not have the product condition health.

6. Incompliance with the obligation to implement the measures and actions necessary to reduce or eliminate health risks caused by the products, as well as measures and actions ordered by the health authorities.

7. Vender to the public products for genetic diagnosis.

8. Conduct clinical investigations in breach of the obligations laid down in the legislation in force, when it is detrimental to the rights, safety and well-being of patients.

9. Conduct clinical investigations without having the consent of the subject of the same or, where appropriate, of his representative, or failure of the investigator to comply with the duty of information on the clinical investigation to whom participates as the subject of the same.

10. Use by a professional product under conditions and for uses other than those indicated by the manufacturer, or by non-qualified or duly trained personnel, with a risk to the health and safety of persons.

11. Run incorrectly, the notified body, the actions entrusted to it, when the safety of the certified products is impaired, as well as continue to certify the corresponding withdrawal designation.

12. To effect advertising directed to the public of the products for genetic diagnosis.

13. Falsify sanitary products, as well as falsify the accrediting documents of conformity.

14. Incompliance, the supplying company, its obligation to have sufficient supply of the market, in an appropriate and continuous manner to enable compliance with the legally established requirements of the supply with health products from the National Health System and ensure supply.

15. Any act of the pharmacy office that induces the user to acquire a greater quantity of medical devices within the pharmaceutical delivery of the National Health System than the truly necessary or demanded by the latter.

Article 113. Infringements in respect of cosmetic products and personal care products.

1. The infringements are considered to be minor, serious and very serious in the light of the health risk criteria, the amount of the possible benefit obtained, the seriousness of the health and social change produced, the generalisation of the infringement and recidivism.

2. They shall constitute administrative offences and shall be sanctioned in accordance with the terms of Article 114 of the following conduct:

a) Mild infractions:

1. Make it difficult for the inspector to work through any action or omission that disturbs or delays the work.

2. Incompliance with the duty to collaborate with the competent health authorities in the assessment, monitoring and control of cosmetics.

3. Incompliance with the requirements, obligations or prohibitions laid down in the applicable regulations, where, in accordance with the criteria referred to in this Article, such non-compliances deserve to be classified as minor or not rating as severe or very severe.

b) Serious infractions:

1. Merchandise as if they were cosmetic products that do not conform to the definition of such established in the current regulations, either by the place of application to which it is intended, or by its purpose.

2. To be marketed as if they were cosmetic products intended for the prevention, diagnosis and treatment of diseases, as well as those destined to be ingested, inhaled, injected or implanted in the human body or the protection against contamination or infection by micro-organisms, fungi or parasites.

3. To market substances or mixtures that are presented as cosmetics without complying with the applicable regulations.

4. Do not provide the competent authority with the information required to supply the person responsible, as well as the lack of communication of any modification of the initial information necessary communicate.

5. Do not provide the competent health authorities with the information required on the substances in which there is doubt in relation to their safety, as well as any other information required by them. authorities for the purpose of market control.

6. The lack of matching between the required mentions of product labeling and the information provided to the competent administration.

7. Merchant Cosmetics that omit on the label any of the required mentions or do not express it in the language and/or in the established terms.

8. Use on the labelling, marketing or advertising of cosmetic products texts, denominations, brands, images or any other figurative symbol or not, in order to attribute to these products features or functions they lack, as well as making claims that fail to meet the established common criteria.

9. To market cosmetic products that lead to confusion with food, medicines, medical devices, biocides or other products, or refer to the treatment of pathologies.

10. Marketed Cosmetics without having performed the safety assessment provided for in the regulation or without having performed it under the conditions laid down.

11. To carry out the activities of manufacturing cosmetic products or any of their phases, such as the control, packaging or labelling, in national territory, or of imports of cosmetics from non-Community countries without a responsible technician with appropriate qualifications in accordance with the specific regulations.

12. Manufacture Or Import Cosmetic Products, or move, extend or modify substantially the activities and facilities without having presented the responsible declaration of compliance with the requirements to perform such activities.

13. Manufacture Or Import Cosmetic Products without complying with the conditions stated in the responsible declaration, as well as the production of cosmetic products without observing the principles of good manufacturing practice.

14. Incompliance with the responsible technician and other personnel with the obligations to their positions.

15. Incompliance of the person responsible or the distributor with the obligations incumbent upon him to bring the non-compliant products into conformity and refuse to implement the measures dictated by the competent health authorities with this end.

16. Incompliance with the person responsible or the distributor with the obligations relating to the identification of the agents preceding or following them in the marketing chain.

17. Incompliance with the responsible person, or the distributor, the obligations incumbent upon them to ensure that the products they place on the market meet the requirements laid down in the regulations.

18. Incompliance with the duty to notify the responsible person or distributor to the health authorities of the serious undesirable effects, the risks presented by the products and the corrective measures taken.

19. To prevent the performance of duly accredited inspectors in the centres where they are manufactured, stored, distributed, sold or used for cosmetic products.

20. To supply cosmetic consumers intended for internal studies or intended to be presented at fairs, exhibitions or demonstrations and whose introduction into Spanish territory has been exclusively authorised for such purposes. end.

21. Distribute Cosmetics without observing the required conditions, as well as put on sale altered cosmetic products, in poor conditions or when the minimum duration date has been exceeded, where applicable.

22. Do not keep at the disposal of the competent health authorities any of the information that is set out in the product information file, or not to express them in Spanish, when it is required.

23. No to the public by the person responsible for the information that is required according to the regulation.

24. To introduce into the market cosmetic products manufactured in installations that have not been the subject of a responsible declaration.

c) Very severe infractions:

1. Trade in cosmetic products or products which are presented as cosmetics which damage human health when applied under normal or reasonably foreseeable conditions of use, or where the products are not consumers of the risks likely to arise from their normal use by means of instructions, warnings and appropriate indications.

2. Merchant cosmetic products that include:

1. No prohibited substances for use in cosmetics.

2. º substances in higher concentrations and/or under conditions other than those established for use in cosmetics.

3. ° Colorants, preservatives or ultraviolet filters other than those authorised for use in cosmetics, or in higher concentrations and/or under conditions other than those established.

4. º substances classified as carcinogenic, mutagenic or toxic to reproduction, outside the conditions laid down in the cosmetics regulations.

3. Marketed Cosmetics that do not meet the established requirements for animal testing.

4. ª Falsify the information to be provided to the health authority, as well as to distort the responsible declaration of compliance with requirements for the performance of manufacturing and import activities.

5. Incompliance with the duty to implement the measures and actions necessary to eliminate health risks caused by cosmetics, as well as measures and actions ordered by the health authorities.

6. To develop cosmetic products in poor technical-sanitary conditions that affect their safety.

7. Manufacture Counterfeit products, enter the market or market counterfeit products.

3. The provisions of the foregoing paragraphs shall apply to personal care products where the object of the infringement is applicable to such products.

Very serious violations will be considered in any case:

a) Markup personal care products without the prescriptive health authorization.

b) Develop personal care products in poor technical-sanitary conditions that affect their safety.

(c) to trade personal care products that harm human health when applied under normal or reasonably foreseeable conditions of use, or where consumers are not advised of the risks that they may have; they may be derived from their normal use by means of instructions, warnings and appropriate indications.

4. The commission of an infringement, preceded by two other immediately lower or equal degrees committed and signed on a firm basis within one year before that commission, shall increase from a minor to serious, or from serious to very serious, such an infringement.

Article 114. Penalties.

1. Infringements in the field of medicinal products shall be punishable by fine, in accordance with Article 111 applying a minimum, average and maximum degree of graduation to each level of infringement, in the light of negligence and intentionality. of the offender, fraud, connivance, failure to comply with the previous warnings, turnover of the company, number of persons affected, injury caused, profits made because of the infringement, permanence or transience of the risks and recidivism by commission within one year of more than one infringement of the same nature where this has been declared by firm resolution:

a) Mild infractions:

Minimum degree: Up to 6,000 euros.

Average Grade: From 6,001 to 18,000 Euros.

Maximum degree: From 18,001 to 30,000 euros.

b) Serious infractions:

Minimum degree: From 30,001 to 60,000 euros.

Average Grade: From 60,001 to 78,000 Euros.

Maximum degree: From 78,001 to 90,000 euros.

c) Very severe infractions:

Minimum degree: From 90.001 to 300,000 euros.

Average Grade: From 300,001 to 600,000 Euros.

Maximum degree: From 600,001 to 1,000,000 euros, being able to exceed that amount until reaching the fivefold of the value of the products or services that are the object of the infringement.

However, in the case of infringements in the field of veterinary medicinal products, the penalty shall only be imposed to the maximum extent where the offending action has caused direct or serious damage to the veterinary medicinal product. public health or food safety.

2. Without prejudice to the fine to be imposed in accordance with the provisions of the preceding paragraph, the infringements in the field of medicinal products shall be sanctioned by the committee, in favour of the public treasury, of the unlawful benefit obtained as a result of the perpetration of the infringement. The resolution of the Administration shall determine for these purposes the amount of the illicit benefit obtained.

3. Without prejudice to the fine to be imposed in accordance with the provisions of paragraph 1 of this Article, the very serious infringement of medicinal products, as referred to in paragraph 23 (c) of Article 11.2, may lead to a disqualification. of the pharmacy office involved in dispensing prescriptions from the National Health System for a minimum period of 3 months and a maximum of 1 year.

4. The penalties for serious and very serious infringements will be published in the official journal once they become firm.

5. It is for the exercise of the power of sanction to the General Administration of the State or to the autonomous communities that hold the inspector's function, in accordance with the provisions of Article 108.

6. In addition, in the case of very serious infringements, it may be agreed, by the Council of Ministers or by the competent bodies of the autonomous communities to which the implementation of the legislation on pharmaceutical products is concerned, to be closed. temporary establishment, installation or service for a maximum period of five years. In this case, the provisions of Article 53 of Law 31/1995 of 8 November of the Prevention of Occupational Risks shall apply.

7. The provisions of the above paragraphs shall apply to infringements in respect of medical devices and cosmetics, in accordance with Articles 112 and 113.

However, in the case of infringements in the field of medical devices and cosmetics, the penalty shall only be imposed to the maximum extent where the infringing action has resulted in direct or direct damage to a serious and direct risk. in public health.

Article 115. Other measures.

1. The closure and closure of establishments, facilities or services which do not have the prior authorisations or health records required, or the suspension of their operation until the defects are remedied, shall not be of a sanction. or meet the requirements for health, hygiene or safety reasons.

2. The authority to which the file is to be resolved may agree to the use of damaged, expired, unauthorised or potentially health-related products and medicinal products.

3. The costs of transport, distribution or destruction of the products and medicinal products, as well as those resulting from the suspension, closure and closure of establishments, facilities or services referred to in the preceding paragraphs, shall be on behalf of the infringer.

Article 116. Prescription.

1. Very serious infractions will be prescribed at five years, the serious ones at two years and the mild ones per year; within the same deadlines they will prescribe the penalties.

2. The limitation period for infringements shall begin to be counted from the day on which the infringement was committed.

Interrupt the prescription of the initiation, with the knowledge of the person concerned, of the sanctioning procedure, resuming the limitation period if the sanctioning file has been paralyzed for more than one month by reason not imputable to the presumed responsible.

3. The limitation period for penalties shall begin to be counted from the day following the day on which the decision imposing the sanction becomes final.

Interrupt the prescription of the initiation, with the knowledge of the interested party, of the execution procedure, returning to elapse the deadline if the one is paralyzed for more than one month for cause not imputable to the infringer.

TITLE X

From the cessation action

Article 117. Prior to the exercise of the cessation action.

1. When an advertising of medicinal products for human use, medical devices or products with alleged properties on health is contrary to this law, to its provisions of development or to Law 14/1986, of April 25, affecting the interests of the Consumers and users will be able to request their cessation:

(a) The Spanish Agency for Consumption, Food Security and Nutrition, and the corresponding bodies or entities of the Autonomous Communities and the competent local authorities in the field of consumer protection.

b) Consumer and user associations that meet the requirements set out in the recast text of the General Law for the Defense of Consumers and Users and other complementary laws, approved by the Royal Decree Legislative 1/2007 of 16 November, or, where appropriate, in the autonomous legislation on consumer protection.

(c) entities in other Member States of the European Union referred to in Article 118.

d) The holders of a right or a legitimate interest.

2. The application shall be made in such a way as to enable it to be satisfied with its date, its receipt and its contents.

3. The cessation may be requested from the beginning until the end of the advertising activity. The action may also be exercised to prohibit the conduct of a conduct where the conduct has been completed at the time of the exercise of the action, if there is sufficient evidence to cause the action to be repeated in an immediate manner.

4. Within 15 days of receipt of the request, the requested party shall inform the applicant in a manner that it wishes to cease the advertising activity and shall effectively proceed to such cessation.

5. In cases of silence or refusal, or where the cessation has not taken place, the applicant may, on grounds of having made the request for termination, bring the action provided for in the following Article.

6. Both the request and the will to cease, or, where appropriate, the refusal to cease advertising, must be communicated to the health authority competent for the control of the advertising of medicinal products.

Article 118. Cessation action.

1. The action of cessation may be exercised in respect of the following conduct, provided that they are contrary to this law, to its implementing rules or to Law 14/1986 of 25 April, and to damage collective or diffuse interests of consumers and users:

(a) Conduct on the advertising of medicinal products for human use, in which case the action may be exercised without the need to submit the prior application referred to in Article 117, which shall be of a potential nature.

(b) Conduct on the advertising of medical devices or products with suspected health properties, subject to the mandatory submission of the application referred to in Article 117.

2. The cessation action is directed to obtain a judgment which condemns the defendant to cease in the conduct contrary to the rules mentioned in the previous paragraph and to prohibit his future reiteration. The action may also be exercised in order to prohibit the conduct of a conduct where the conduct has been completed at the time of the exercise of the action, if there is sufficient evidence to cause the action to be repeated in an immediate manner.

The competent health authority in the field of control of the advertising of medicinal products must be notified of both the action's interposition and the judgment which, where appropriate, is given.

3. They will be entitled to exercise the cessation action:

(a) The Spanish Agency for Consumption, Food Security and Nutrition and the corresponding bodies or entities of the Autonomous Communities and local corporations.

b) Consumer and user associations meeting the requirements set out in the recast text of the General Law for the Defence of Consumers and Users, or, where appropriate, in the autonomous legislation on consumer protection. consumer protection.

c) The Fiscal Ministry.

(d) entities in other Member States of the European Union constituted for the protection of collective interests and the diffuse interests of consumers who are enabled by their inclusion in the published list to this end in the Official Journal of the European Union.

The Judges and Courts shall accept such a list as evidence of the ability of the entity to be a party, without prejudice to examining whether the purpose of the entity and the interests involved legitimize the exercise of the action.

e) The holders of a legitimate right or interest.

All entities mentioned in this article may be personified in the processes promoted by any other entity, if they deem it appropriate for the defense of the interests they represent.

TITLE XI

Rates

Article 119. Creation, regulation and territorial scope.

1. The fee for the provision of services and the carrying out of activities of the General Administration of the State in the field of medicinal products, medical devices, cosmetic products and personal care products is hereby established.

2. The tax paid in this title shall be governed by the law, in its absence, by Law 8/1989, of 13 April, of Public Fees and Prices, and regulatory provisions for development.

3. That fee shall apply throughout the national territory in accordance with the provisions of Article 124, and without prejudice to the powers of the autonomous communities.

Article 120. Taxable fact.

constitutes the taxable fact of the provision or performance, by the competent bodies of the General Administration of the State, of the services or activities referred to in Article 123 concerning medicinal products legally recognised, medical devices, cosmetic products and personal care products, pharmaceutical laboratories and distribution entities.

Article 121. Exemptions.

1. The provision of services or activities relating to the manufacture of "medicinal products without commercial interest" referred to in Article 3.3 shall be exempt.

2. Services and activities shall be exempt by modifications to the packaging material intended to make the printing in the language of braille effective, in accordance with the provisions of Article 15

5).

3. Services and activities relating to advanced therapy medicinal products which must be carried out by entities of a public nature integrated into the National Health System as well as those which have to be carried out by public bodies shall be exempt from the payment of the fee. are not intended for the placing on the market of such products.

4. Amendments or variations in authorisations granted by the Spanish Agency for Medicinal Products and Health Products shall be partially exempt from the payment of the fee for the fee for the approval, as a rule. regulation, a new general regulation. The fee shall be reduced by 95% of the amount established in each case.

5. Holders of marketing authorisations for medicinal products authorised when, for reasons of public interest, the Spanish Agency for Medicinal Products and Sanitary Products or the Spanish Agency, shall be exempt partially from the payment of the corresponding fee. European Commission calls for amendment. The fee will be reduced by ninety-five percent of the amount set in each case.

6. For veterinary medicinal products intended exclusively for minor species or minor uses, an exemption of 70% of the fees for marketing authorisations shall apply to line extensions to minor species or uses. (i) minor of medicinal products already authorised to major species, modifications to the marketing authorization, scientific advice, products in the veterinary clinical research phase, veterinary clinical trials, renewal of the authorisation, presentation of the simple annual declaration of intent of marketing and periodic safety reports, of veterinary medicinal products authorised by national procedure, of mutual or decentralised recognition. It shall not apply to the procedures for the transmission of ownership and/or representative of the holder.

7. Scientific advice on medicinal products containing only questions relating to paediatric development shall be partially exempt from the payment of the fee. The fee shall be reduced by 95% of the amount established in each case.

Article 122. Taxable person.

It shall be taxable persons of the natural or legal persons who request the provision of services or the performance of the activities that constitute the taxable event.

Article 123. Amount.

1. The amount of each euro fee shall be:

Group I. Medicinal products for human use.

Epiphon

Description	Euros
	, authorization, and enrollment of new
1.1	Rate by Evaluation, Authorization, and registration of a new medicinal product for human use (an authorisation file submitted in accordance with Article 17, except that referred to in Article 17.3).	20.734.46
1.2	Rate for evaluation, authorization, and enrollment in the registration of a new generic human use drug (authorization file presented as Article 17.3).	8.434.22
1.3	Rate for evaluation, authorization, and enrollment in the registry of a new medicinal gas.	8.434.22
	Transmission of entitlement of a human use
1.4	Rate by the procedure transmission of ownership of the authorization of a medicinal product for human use, or modification of the holder's representative.	704.55
	, authorization, and enrollment in the recording of a variation of a human-use
1.5	Rate by procedure modification of the authorization of a medicinal product for human use, qualified as of "major importance" type II.	7.122.25
1.6	Rate by the procedure for modifying the authorization of a human-use drug, qualified as type IB.	1.249.22
1.7	Rate by modification procedure of the authorisation of a medicinal product for human use, qualified as type IA (including type IA of immediate notification).	724.42
	authorization refresh
1.8	Rate by the renewal procedure for authorization of a human use drug.	2.342.71
	Maintenance Rate authorized
1.9	Simple annual rate of a human use drug already authorized.	373.70
	import
1.10	Rate by the authorization procedure for the "parallel import" of a human-use drug.	905.45
>1.11	Rate by the authorization modification procedure for the "  parallel import " of a human use drug.	366.49
	Rate by the Renewal procedure of the authorization for the "parallel import" of a drug for human use.	366.49
	Import notification rate.	359.04
	, blood products, and bulk release
	Rate by issue of European batch release certificate for human use vaccines and blood products when analysis is required of one drug per batch.	1.212.00
>1.15	Rate for batch release of blood products and vaccines according to Articles 41.4 and 43.3 of Royal Decree 1345/2007, of October 11:.
	(a) each individualized request.	101.00
	(b) between 6 and 10 requests/year (per year).	505.00
	(c) between 11 and 40 requests/year (per year).	1.515.00
	(d) between 41 and 160 requests/year (per year).	3.535.00
	(e) by more than 160 requests/year (per year).	5.050.00
	Rate for the European certificate of batch release for vaccines and blood products for human use when the bulk (bulk) analysis is required.	339.36
	Galenic
	Rate by evaluating a request for statement of galenic innovation of therapeutic interest.	984.04
	applicable to the export
>1.18	Export authorizations, to intra-and third-country countries, narcotic drugs, and psychotropic drugs.	171,70
			Other
1.19	Rate for expected performances in the Article 124.6.	366.49
	Rate by reservation of a vacancy to act as a State Reference member in a decentralized or mutual recognition procedure.	757.50

Group II. Allergen medicines.

Epiphon

Description	Euros
	, authorization, and enrollment in the registry of a new human-use allergen for diagnostic
		2.1 The_table_table_izq"> Rate by National Procedure.	860.93
	2.2		2.2	2.2	Rate by the procedure for the transmission of the entitlement of an allergen medicinal product for use diagnostics.	472.46
	, authorization, and enrollment in the registry a variation of an allergen drug for diagnostic use
2.3	Rate by the procedure for the modification of the authorisation of an allergen medicinal product for diagnostic use, qualified as "major importance" type II.	502.74
2.4	Rate by the modification procedure authorization of an allergen drug for diagnostic use, defined as type IB.	88.19
2.5	Rate by the authorization modification procedure an allergen drug for diagnostic use, qualified type IA (including immediate notification IA type).	51.14
			2.6
	2.6	2.6	2.6	2.6	Zant_table_izq"> Rate by the renewal procedure for authorization of an allergen drug for diagnostic use.	307.38
	authorized allergen drug maintenance
	2.7	Simple annual rate of an allergen drug for diagnostic use already authorized.	373.70
2.8
Rate by Release bulk authorization.	614,77

Group III. Medicinal plant medicines.

Epiphon

Description	Euros
	, authorization, and enrollment in the registration of a new traditional herbal medicine (MTP)
		3.1 Table_table_izq"> Rate by a national simplified procedure.	2.186.94
	Evaluation, authorization, and enrollment in the registration of a variation of a traditional plant-based drug (MTP)
3.2	Rate by the modification procedure authorization of a traditional herbal medicinal product (MTP).	338.98
	Evaluation, authorization, and enrollment in the registry of a new plant-based human-use drug for well-established
3.3	National Procedure Rate, except heading 3.1.	8.434.22
	-based drug entitlement transmission
3.4	Rate by the transmission procedure of the entitlement of an authorization Traditional herbal medicinal product (MTP) or a plant-based medicinal product authorised for the purpose of use as well established.	704.55
	, authorization, and enrollment in the record of a variation of a plant-based
3.5	Rate by the modification procedure the authorisation of a medicinal product for human use on the basis of plants, rated as 'major' type II.	1.249.22
3.6	Rate by procedure for modifying authorization of a drug plant-based human use, qualified as type IB.	557.67
3.7	Rate by procedure modification of the authorisation of a medicinal product for human use on the basis of plants, rated as type IA (including immediate notification IA type).	317.85
	marketing
3.8	Rate by the refresh procedure the authorization of a traditional herbal medicinal product (MTP).	3.9
	3.9	3.9	3.9	3.9	3.9	3.9 for well-established use.	1.522.95
	maintenance fees licensed plant-based
	Simple annual rate of a traditional herbal medicine (MTP) already authorized.	373.70
3.11	Simple annual rate of a well-established use-authorized plant-based drug.	373.70

Group IV. Homeopathic medicinal products for human and veterinary use.

Epiphon

Description	Euros
	, authorization, and enrollment in the registry of a new homeopathic drug with no approved therapeutic
	Rate by a national simplified procedure:
4.1	One single strain.	569.69
4.2	Between two and five strains.	4.3
	4.3	4.3 Zant_table_body_izq"> More than six strains.	932.32
	, authorization, and registration of a variation of a homeopathic drug without approved therapeutic
4.4	Rate by the procedure for modifying the authorization of a drug homeopathic without approved therapeutic indication.	329.01
	, authorisation and registration of a new homeopathic medicinal product with approved therapeutic
4.5	National Procedure Rate.	8.434,
	Transmission of entitlement of a homeopathic drug with or without therapeutic indication
4.6	Rate by the transmission procedure of the entitlement of the authorisation of a homeopathic medicinal product with or without approved therapeutic indication, or holder representative.	704.55
	, authorization, and enrollment in the recording a variation of a homeopathic drug with approved therapeutic
4.7	Rate by the procedure for modifying the authorization of a homeopathic medicine with approved therapeutic indication, qualified as of "major importance" type II.	1.249.22
4.8	Rate by the procedure for modifying the authorization of a homeopathic drug with approved therapeutic indication, qualified as type IB.	557.67
4.9	Rate by the procedure modification of the authorisation of a homeopathic medicinal product with approved therapeutic indication, qualified as type IA (including type IA of immediate notification).	317.85
	Authorization Renewal
4.10	Rate by the procedure for renewing the authorization of a homeopathic medicinal product without approved therapeutic indication.	307.38
4.11	Rate by the renewal procedure for authorization of a homeopathic drug with approved therapeutic indication.	1.522.95
	Rates of maintenance of authorized homeopathic
4.12	Simple annual rate of a homeopathic drug with no approved therapeutic indication already approved.	90.90
4.13	Simple annual rate of a homeopathic medicinal product for human use with approved therapeutic indication authorized.	373.70

Group V. Clinical research.

Epiphon

5.2

Description	Euros
5.1	Rate by a procedure of evaluation of the first clinical trial with unauthorized drugs in a country belonging to the International Conference of Harmonization (ICH) with active principles or combinations of active principles not authorized in Spain.
5.2
	a) Authorization of a clinical trial with an authorized drug in a country belonging to the International Conference of Harmonization (ICH), other than Spain.	404.00
	b) Authorisation of clinical trials with medicinal products not authorised in any country belonging to the International Conference on Harmonisation (ICH) following the first clinical trial under the heading 5.1.
	c) Authorization of a clinical trial with the characteristics indicated in section 5.1 in the cases of a reiteration of the application for authorization when the result of the first request was a withdrawal or the non-authorization of the trial
5.3	Procedure rate:
	a) Authorization of a clinical trial with medicinal products authorised and registered in Spain, regardless of the specific labelling of these for the test.	112.30
	b) Authorization a clinical trial whose promoter is a researcher or group of researchers in which a Pharmacy Service is responsible for making or masking investigational medicinal products
5.4	Qualification procedure as a product in phase clinical research of an unauthorized veterinary medicinal product in Spain.	278.17
5.5	Rate by Veterinary Clinical Trial Procedure.	112.30

Group VI. Pharmaceutical laboratories, manufacturers, importers or distributors of active substances and other entities carrying out activities with medicinal products or active substances.

Epiphon

6.4.b)

6.10

Description	Euros
6.1	The opening authorization procedure for a pharmaceutical lab.	5.916.36
>6.2	The modification procedure for the authorization from a pharmaceutical laboratory for minor changes in the same.	329.01
6.3.a)	Procedure for modifying the authorization of a pharmaceutical lab for major changes in it when the inspecting actions do not include an inspection visit.	3.896, 36
6.3.b)	Procedure for modifying the authorization of a pharmaceutical lab for major changes in the procedure when the inspecting actions include an inspection visit.	6.4.a
6.4.a)
Individualized Inspectors, except in the case of a complaint or at the request of a Representative user or consumer association, at national level.	6.4.b
Individualized Inspectors, except in the case of a complaint or at the request of a Representative user or consumer association, in third countries.	10.908.00
6.4.c)	Individual inspectorates in third countries, non-prescriptive, at the request of the interested.	20.200.00
6.5	Drug Manufacturing Authorization Procedure approved in other countries and not registered in Spain.	643.22
6.6	Procedure exceptional manufacturing authorization by third parties of medicinal products for human and/or veterinary use.
6.7	6.7	6.7	6.7	6.7	6.7	6.7	6.7	customs.	1.313.00
	Resolution of plant crop authorization that you can destined for the manufacture of narcotic drugs and psychotropic drugs.	606.00
	Initial enrollment, notification of mandatory modifications, or annual update of the record	808.00
Enrollment in the registry of persons engaged in the intermediation in the distribution of drugs human usage.	252.50

Group VII. Certifications and reports.

Epiphon

Description	Euros
7.1	Rate by issue of a certification.	141.86
7.2	Rate for scientific advice for medicines that include questions multidisciplinary on (a) quality, safety and clinical development, or (b) quality and clinical development, or (c) safety and clinical development, or (d) pre-referral advice for a dossier.	4.224.39
7.3	Rate for scientific advice for drugs that include questions about (a) clinical development, or (b) quality and safety, or (c) quality and bioequivalence studies in the case of generic drugs.	3.061, 44
	7.4	Rate for scientific advice for drugs that include questions about (a) quality, or (b) safety, or (c) bioequivalence studies in the case of generic drugs.	2.022.74
7.5	Rate for tracking advice for assumptions included under item 7.2.	2.022, 74
	Rate for tracking advice for assumptions included under item 7.3.	1.530.73
	Rate for follow-up advice for the assumptions included under item 7.4.	984.04
	Rate for advice for classification of variations not classified according to Article 5, and for grouping of variations, according to Article 7 of Commission Regulation (EC) No 1234/2008 European.	492.01
	Rate for scientific advice on medicines for use paediatric in any of the assumptions included in the above headings.	205.01
7.10	Scientific/Technical Advice on the design of installations and manufacturing processes with the correct manufacturing rules.	492.01

Group VIII. Healthcare products, cosmetics, and personal care products.

Epiphon

8.32

Description	Euros
8.1	Cosmetics special declaration procedure.	487.90
8.2	Individualized authorization and registration procedure for personal care products and disinfectants.	487.90
8.3	Registration procedure and health product enrollment.	101.00
8.4	Modification procedure and validation of personal care products and disinfectants.	170.02
8.5	Certification procedure.	147.82
8.6	The verification and control procedure for the declaration responsible for the manufacturing activity of cosmetic and personal care products.
		8.7 Zant_table_to_izq"> Check and control procedure for the declaration responsible for the import activity of cosmetic and personal care products.	369.63
	Checking and controlling the declaration responsible for changes in the manufacturing activity of cosmetic and care products personal.	369.63
8.9	The check and control procedure for the declaration responsible for modifying the import activity for cosmetic and personal care products.	170.02
8.10	Individualized inspecting actuations for declaration checking responsible.	717.08
8.11	Cosmetic ingredients confidentiality authorization procedure.	487.90
8.12	Pre-license procedure for sanitary products and disinfectants: build-build, pool.	8.13
8.13	Pre-operating license procedure for sanitary products and disinfectants: import establishment.	369.63
8.14	Procedure for modifying the operating license for health products and disinfectants to be used for placement: Build, pool.	717.08
8.15	Procedure for modifying the previous operating license of sanitary products and disinfectants in the about your placement: import establishment.	369.63
8.16	Procedure modification of the prior operating licence of establishments of medical devices and disinfectants.	170.02
8.17	Procedure for revalidation of the license sanitary products and disinfectants establishments: manufacturing facility.	517.47
8.18	Revalidation procedure for the health products and disinfectant establishments license: import establishment.	317.88
8.19	Authorization of clinical investigations of sanitary products.	808.00
8.20	Active Principle Assessment Report embedded in a healthcare product.	1.478.50
8.21	Evaluation of CE "marked CE" certification records for health products belonging to the same family by quality assurance system.	2.460.36
8.22	Evaluation of "CE marking" certification files for medical devices EC type-examination, combined with quality assurance of production, EC verification or guarantee of product quality.	887.10
8.23	Marking certification file assessment EC "of medical devices belonging to the same family, by" EC "declaration of conformity combined with quality assurance of production," CE " verification or quality assurance of the product.	8.24
8.24	8.24 The_table_table_izq"> Product Verification and Product Batch	230.17
8.25	The "CE marked CE" certification case assessment for design "CE" health products.	1,626.37
>8.26	Initial audit according to full quality assurance system.	3.232.00
8.27	Initial audit according to production quality assurance.	2.686.60
8.28	Initial audit according to product quality assurance.	2.154, 33
	8.29	Tracking and Certification Extension Audits.	2.154.33
8.30		1.077.67
8.31	Modification of administrative data in the "CE marking" certification.	147.82
8.32	Extensions of the "CE marked" certifications.	147.82
8.33	Healthcare product modification procedure.	60.60

Group IX. Veterinary medicinal products.

Epiphon

9.2

9.12

Description	Euros
9.1	Rate per marketing authorization request for a veterinary medicinal product, except for the requests referred to in Article 17.3.	10.367,
Rate per marketing authorization request for a generic veterinary medicinal product (case submitted under article 17.3).	4.217.10
9.3	Rate by the transmission procedure of the entitlement of a veterinary medicinal product, or by modification of the owner's representative.	704.55
9.4	Rate by the procedure for modifying the authorization of a veterinary medicinal product, qualified as "major importance" type II.	3.561, 13
	9.5	Rate by procedure for modifying the authorization of a veterinary medicinal product, defined as type IB.	1.224.72
9.6	Rate by the procedure for modifying the authorization of a veterinary medicinal product, qualified as type IA (including immediate notification type IA).	724.42
9.7	Rate by procedure of renewal of a drug's authorization veterinarian.	2.342.71
9.8	Rate per simple annual declaration of intent to market an already authorized veterinary medicinal product.	120.20
	Rate by the authorization procedure for "parallel import" of a veterinary medicinal product.	9.10
	9.10	Za_table_table_izq"> Rate by periodic report evaluation evaluation of a veterinary medicinal product, this or not registered the drug in Spain.	382.71
9.11	Rate by annual report evaluation of a veterinary medicinal product, whether or not the product is registered in Spain.	757.84
Rate per three-year, three-year periodic safety report evaluation of a veterinary medicinal product, whether or not the drug is registered in Spain.	2.273.52
	9.13	Rate by issue of European batch official release certificate for drugs immunological veterinary medicinal products under Article 81 of Directive 2001 /82/EC.	339.36
9.14	Rate by issue of European certificate of official batch release for immunological veterinary medicinal products under Article 82 of the Directive 2001 /82/EC.	1.212.00
9.15	Rate for booking a vacancy to act Spain as a Reference Member State in a Decentralized or Mutual Recognition procedure.	404.00

Group X. Financing procedures from public funds and pricing of medical devices.

Epiphon

Description	Euros
10.1	Procedure for including a healthcare product in the pharmaceutical delivery of the National Health System.	347.90
10.2	Exclusion procedure for a healthcare product in the National Health System pharmaceutical capability.	347.90

2. For the purposes of the preceding paragraph, the second and successive applications for authorisation and registration in the register of other pharmaceutical forms, routes of administration and concentration of an already authorised medicinal product shall be understood as an extension of line. and enrolled.

The rate of the rate of line extensions will be seventy percent of the first authorization of the medication.

In the case of medicinal products for veterinary use, the extension of an authorisation to new target species will be considered as an extension of the line provided that they are food producing species.

They will constitute an extension of line those modifications that require the submission of a new application for authorization, in accordance with the European norm that regulates the modifications of authorization of medications granted by the competent authority of a Member State.

The provisions in the preceding paragraphs concerning the line extensions are also applicable when the product is not yet authorized and line extensions of a main application are presented in parallel.

For the purposes of the rate described in the headings 8.1 and 8.21, you have the consideration of:

(a) "cosmetic product subject to a special declaration", which, subject to the corresponding authorisation of the Spanish Agency for Medicinal Products and Health Products, includes colouring agents, preservatives or Ultraviolet filters, not included among the substances admitted as components of cosmetic products.

(b) "Family of medical devices" means a set of medical devices which, belonging to the same category, are intended for identical or similar sanitary applications.

3. The amount of the fees for the services and activities of the General Administration of the State in the field of medicinal products, medical devices, cosmetic products and personal care products, as provided for in Law 8/1989, of 13 of April, may be amended through the State General Budget Law.

4. Where the assessment and control of a medicinal product or medical device requires action abroad or exceptional costs, the corresponding fees shall be settled on the actual cost of the service in which the case is determined. requirement.

The actual cost of the service shall also be settled for the costs of travel, subsistence and testing resulting from the actions referred to in the headings 6.1, 6.4 (a), (b) and (c), 8.22, 8.24, 8.26, 8.27, 8.28, 8.29, 8.30 and 10.1.

5. Where in the authorisation and registration procedure for registration of a medicinal product for human or veterinary use, which corresponds to the fees provided for in the headings 1.1, 1.2, 1.3, 1.5, 9.1, 9.2 and 9.4, the application submitted shall be rejected In the validation phase, 70 percent of the total amount of the fee will be returned.

For the purposes of this law, the administrative action, developed for the purpose of verifying that the application meets all the necessary requirements to carry out the providing the service or performing the administrative activity.

6. Amendments to the authorisation of a medicinal product, which are the result of a decision of the European Commission and which do not involve scientific evaluation by the Spanish Agency for Medicinal Products and Products, will become the fee provided for under heading 1.19.

In cases of grouping of independent modifications Type IA, being these same or different, affecting several drugs belonging to the same holder and whenever they are presented at the same time and in a single format on request in accordance with Article 7 of Commission Regulation (EC) No 1234/2008 of 24 November 2008 on the examination of amendments to the terms of the marketing authorisations for medicinal products for human use and veterinary medicinal products, shall bear for each of the same rate of change a fee main and reduced rates for the remaining modifications.

When a modification affects different medicinal products from the same holder, and which involves a single scientific assessment, the second and subsequent evaluation shall bear the fee provided for under heading 1.19.

When different modifications are made to the authorization to place a medicinal product on the market, the total amount of the medicinal product may not exceed the rate laid down for the authorization and registration procedure in the Record of the type of medicinal product concerned.

In the case of a grouping of independent amendments affecting the same medicinal product and provided that all are submitted at the same time and in a single application format, in accordance with Article 7 of Regulation (EC) No 123/2014. 1234/2008 of the European Commission, a fee shall be required for each of the amendments requested.

The rate for epigraph 7.2, " Rate for scientific advice for drugs that include multidisciplinary questions on (a) quality, safety and clinical development, or (b) quality and clinical development, or (c) safety and clinical development, or (d) pre-referral advice for a dossier " shall be reduced by 25% for scientific advice including questions on the development of clinical efficacy only; or pre-clinical quality and safety; or bioequivalences.

7. The rates of decentralised procedures for medicinal products for human or veterinary use, resulting in a national authorisation in which Spain acts as a reference Member State (subject to the provisions of headings 1.1, 1.2, 1.3, 1.5, 1.6, 1.7, 1.8, 3.1, 3.3, 3.5, 3.6, 3.7, 4.1, 4.2, 4.3, 4.5, 4.7, 4.8, 4.9, 9.1, 9.2, 9.4, 9.5, 9.6 and 9.7) will be increased by 25% on the corresponding rate.

In mutual recognition procedures for medicinal products for human or veterinary use in which Spain acts as a reference Member State, a third part of the full reference rate (benefits of the headings 1.1, 1.2, 1.3, 3.1, 3.3, 4.1, 4.2, 4.3, 4.5, 9.1 and 9.2).

The rate of heading 1.20, which shall apply to any medicinal product for human use, including special medicinal products, shall be deducted from the total amount to be paid if the person concerned submits an application. on a decentralised or mutual recognition procedure, acting as a Member State of reference.

The rate of heading 9.15, which shall apply to any veterinary medicinal product, shall be deducted from the total amount to be paid if the person concerned submits an application for a procedure. decentralised or mutual recognition, acting as a Member State of reference.

Article 124. Accrual.

The fee will become payable when the application, which starts the file, has entry in the register of the Spanish Agency for Medicines and Health Products or the Ministry of Health, Social Services and Equality, according to its respective competence, at which point the service delivery or the performance of the administrative activity is initiated.

Article 125. Payment.

1. The fee shall be paid in accordance with the provisions of Law 8/1989 of 13 April 2003, Law 58/2003 of 17 December, General Tax and other implementing rules.

The payment of the fees referred to in this law will be made, preferably, by way or electronic means, as provided for in Law 11/2007, of June 22, of Electronic Access of Citizens to Public Services.

2. No application shall be processed which is not accompanied by the supporting evidence of the applicable fee.

3. Where the fee is paid, the Administration may not process the corresponding procedure for reasons not attributable to the taxable person, the refund of which shall be eighty per cent of its amount.

4. If the fee is paid, the taxable person shall submit the corresponding application within 10 days of entry.

5. The management of the fees regulated in this law is, on a voluntary basis, the Ministry of Health, Social Services and Equality and the Spanish Agency for Medicines and Health Products, according to their respective competence.

6. The Spanish Agency for Medicines and Health Products may use to obtain the effectiveness of its debits in the nature of public law, the administrative procedure of the award, provided that such debits are in period executive. The Spanish Agency for Medicinal Products and Sanitary Products may agree with the State Administration of Tax Administration to collect its revenue from public law in the form provided for in the General Rules of Collection, approved by Royal Decree 939/2005 of 29 July.

Article 126. Rate-return assumptions.

The return of income by fees shall be carried out, in addition to the assumptions referred to in Article 221 of Law 58/2003 of 17 December, when the fee is paid, the taxable person does not submit the application for the benefit of the service or activity within the period of 10 days following the entry set out in Article 125.4, provided that it is not attributable to the taxable person, who is accredited in a feisty manner. This return will be eighty percent of its amount.

Additional disposition first. Guarantee of supply of medicines and sanitary products and coordination of availability of fluids and other elements.

1. In order to develop and promote the necessary activities in the field of supplies of medicinal products and medical devices and to coordinate the adequate availability of blood and other fluids, glands and human tissues and their components and their components The following tasks shall be carried out by the Ministry of Health, Social Services and Equality, in addition to the tasks assigned to it by the law:

(a) Ensure the deposit of medicinal products for psychoactive substances in accordance with the provisions of international treaties.

b) Authorize the importation of foreign and urgent non-authorized medication in Spain.

c) Maintain a strategic state deposit of medicines and medical devices for emergencies and catastrophes.

d) Conduct the procurement and distribution of medicines and medical devices for international cooperation programmes.

e) Coordinate the supply of vaccines, medicines and other products for health campaigns, the acquisition and distribution of which is decided by the different health administrations.

f) Promote the manufacture and marketing of "medicines without commercial interest".

2. It shall also exercise the coordination of exchanges and the transport of blood and other fluids, glands and human tissues and their constituents and derivatives.

Additional provision second. Application of the law to the health services of the Armed Forces.

The application of the criteria and rules laid down in this law to the health services of the armed forces will be determined in accordance with the joint proposal of the Ministries concerned.

Additional provision third. Application of the law to medical devices, cosmetics and personal care products.

1. In accordance with this law, the conditions and requirements to be met by medical devices for their manufacture, import, clinical investigation, distribution, marketing, placing on the market, shall be determined in accordance with this law. service, dispensing and use, as well as the respective administrative procedures, in accordance with the provisions of the European Union legislation.

2. The provisions of the above paragraph shall also apply, where appropriate, to personal care and cosmetic products.

3. The manufacturing and import activities of cosmetics and personal care products are subject to the regime of responsible declaration, as laid down in Article 71a of Law 30/1992 of 26 November. This responsible statement must be submitted to the Spanish Agency for Medicines and Health Products. The presentation of the responsible declaration shall allow for the initiation of the activities, without prejudice to the subsequent verification by the Spanish Agency for Medicinal Products and Health Products, by means of documentary verification and, where appropriate, inspection, of the elements and circumstances highlighted by the person concerned in the responsible declaration.

4. The fees necessary shall be payable to cover the costs of verification of the responsible declaration and of the inspection which, where appropriate, is necessary.

Additional provision fourth. Deposit of medicines in prisons.

The penitentiary centers may request from the competent administration in each case authorization to maintain a deposit of medications for the assistance to the inmates, under the supervision and control of a pharmacist of the licensed pharmaceutical services of the nearest National Health System hospital.

Additional provision fifth. Procedure for the total or partial exclusion of medicinal products from the pharmaceutical provision of the National Health System.

The Government by royal decree, after reporting by the Interterritorial Council of the National Health System, will establish the form, requirements and conditions of application of the criteria contained in Article 92 and will determine the total or partial exclusions of the groups, sub-groups, categories or classes of medicinal products from the funding from public funds.

Additional provision sixth. Sales volume contributions to the National Health System.

1. Natural persons, business groups and legal persons not integrated in them who are engaged in Spain in the manufacture, import or offer to the National Health System of medicinal products and/or medical devices which, financed by public funds are dispensed in pharmacy offices through official prescription or the order of supply of the National Health System, in national territory, the quantities that they will be applied on their own will have to be entered on a four-monthly basis volume four-monthly sales through said prescription or dispensing order the percentages referred to on the following scale:

Sales to PVL		Contribution
From
0.00	3.000,000.00	1.5
	3.000.000.01
2.0

On the assumption that the total volume of sales of medicines and medical devices to the National Health System is, in current terms, lower than the previous year, the government will be able to review the previous ones. percentages of input.

The amounts resulting from the application of the previous scale will be reduced according to the valuation of the companies under the Profarma programme according to the following percentages:

a) Not valued: 0.00.

b) Acceptable: 5%.

c) Good: 10%.

d) Very good: 15%.

e) Excellent: 25%.

Those companies classified in the Profarma program as very good or excellent, who participate in R & D consortia or make temporary partnerships for this purpose with other companies established in Spain and R & D centers Public and private, to carry out basic and pre-clinical research of relevance through specific and determined projects, they will be able to benefit from an additional ten percent of the contribution.

The minorations that may affect these returns will take effect from the last resolution of the Profarma program.

The business groups will communicate to the Ministry of Health, Social Services and Equality during the month of January each calendar year, the companies integrated into them. Where the composition of a business group is changed during the course of the year, the communication shall take place during the month in which the change took place. For the purposes of the above, it is considered that undertakings constituting a unit of decision, in the terms of Article 4 of Law No 24/1988 of 28 July 1988 on the Stock Market, are considered to belong to the same group.

2. The Ministry of Health, Social Services and Equality, in accordance with the provisions of the previous paragraph and the sales of the current financial year, shall communicate the amount to be entered for each manufacturer, importer or offeror concerned, as well as the time limit. of the income of that quantity. In the first period of the following financial year, where appropriate, the regularisation of four-monthly liquidations shall be carried out, in the event that the data not taken into account in the partial settlements are to be incorporated into the file.

3. The amounts to be entered will be used for research, in the field of biomedicine, in sufficient quantity to finance the needs of clinical research carried out, through the sector initiative of research in biomedicine and health sciences, entering the case of the Carlos III Health Institute. The rest of the funds will be devoted to the development of policies for health cohesion, training programs for medical doctors, dentists, pharmacists and nurses, as well as programs for the health education of the population in order to promote rational use of the drugs, according to the distribution to be determined by the Ministry of Health, Social Services and Equality, prior to the Interterritorial Council of the National Health System, entering the Public Treasury.

Additional provision seventh. Preservation of organs for transplants.

The solutions for organ preservation for transplants will be governed, as soon as they are applicable, as provided for in this law for medicines.

Additional disposition octave. Medicinal products subject to advertising.

The price fixed on the packaging of medicinal products which are the subject of the advertising provided for in Article 80 shall be considered as the maximum selling price to the public. The maximum discount applicable to pharmacy offices shall be established.

Additional provision ninth. Genetically modified organisms.

The activities of the contained use and voluntary release of genetically modified organisms which are incorporated or may be incorporated into medicinal products for human or veterinary use shall be subject to the provisions of the Law 9/2003 of 25 April 2003 establishing the legal regime for the contained use, voluntary release and placing on the market of genetically modified organisms and in their development legislation.

Additional provision 10th. Participation of the Autonomous Communities and the mutual societies of officials in decision-making procedures for medicinal products and medical devices.

The autonomous communities and the Mutualities of civil servants will participate in the terms established in regulation, in the Rector Council of the Spanish Agency for Medicines and Health Products, as a collegiate body of address of the body. The Agency will also have the collaboration of independent experts of recognised scientific prestige proposed by the Autonomous Communities.

The Ministry of Health, Social Services and Equality will provide a report to all the Autonomous Communities and the Mutualities of officials, at each meeting of the Permanent Commission of Pharmacy of the Interterritorial Council. of the National Health System, identifying the name of the medicines and medical devices that have been authorized by the Spanish Agency for Medicines and Health Products since the last meeting of the Council, as well as the price of those products. medicines and medical devices which have been included in the financing of the National Health System.

Additional provision eleventh. Quality assurance, safety and efficacy of pharmaceutical products and the protection of patients.

The authorities, in the exercise of their powers, shall ensure compliance with the provisions of this law for the purpose of ensuring the quality, safety and efficacy of pharmaceutical products and the protection of the patients. In particular, they shall ensure, through their inspection and control functions, compliance with the requirements of the pharmaceutical legislation.

Additional disposition twelfth. Placement or delivery of bespoke medical devices by an optional.

The placement or delivery of medical devices by an optional, in the exercise of their professional privileges, shall not be considered as dispensing, marketing, selling, distributing, supplying or putting into the market for the same, for the purposes of Articles 4.1 and 111. In any case, the optional should separate its fees from the manufacturing costs.

Additional disposition thirteenth. Information on the lower prices of homogeneous groups of medicinal products and medical devices.

1. For the purposes of applying the conditions of supply and replacement laid down in Articles 88 and 90, respectively, the General Directorate of the Basic Portfolio of Services of the National Health and Pharmacy System of the Ministry of Health, Services Social and Equality will publish on its website, together with the Nomenclator of pharmaceutical products of the National Health System, information on the homogeneous groupings of presentations of medicines and medical devices. for non-hospitalized patients who require for their medical prescription or order of dispensing.

Child pricing information will be updated on the first business day of each month and will be published on the Ministry of Health, Social Services and Equality website.

2. In each homogeneous group of medicinal products, the presentations of the medicinal products financed with the active substance/s in terms of dose, content, pharmaceutical form or pharmaceutical form, and via the administration, which may be subject to exchange in your dispensation.

The homogeneous groups of medicinal products, consisting exclusively of a medicinal product and its licences with the same price as the reference medicinal product, shall be differentiated.

3. In addition, in each homogeneous grouping of medical devices, the presentations financed, having the same characteristics, type, size and content and being classified according to the groups, shall be integrated, wherever possible. relating to Annexes I and II to Royal Decree 9/1996 of 15 January 1996 regulating the selection of effects and accessories, their financing with social security funds, or State resources affected by health and their supply arrangements and dispensing to non-hospitalized patients may be subject to exchange in their dispensation.

4. If the variations experienced in the prices of the medicinal products or sanitary products so advise and, after agreement of the Permanent Commission of Pharmacy of the Interterritorial Council of the National System of Health, the mentioned Direction General may update the information of the minor prices, affecting in its case such update to all the groupings, or to the groupings that are considered relevant, as well as to incorporate new groupings, and to establish deadlines of co-existence of prices and return of stocks, presentations of medicinal products and medical devices which have voluntarily reduced their price on the basis of the lower price of each group, allowing that reduction to be carried out without change from the national code.

For information purposes, the updates of the lower price information will be incorporated into the National Health System's pharmaceutical product classification, finalized the deadlines that would have been set.

Additional disposition fourteenth. Derogation from the legal regime provided for in Article 43.1 of Law 30/1992 of 26 November.

1. Without prejudice to the procedures relating to the additional twenty-ninth provision of Law 14/2000 of 29 December, of Fiscal, Administrative and Social Order Measures, corresponding to the derogation provided for in Article 43.1 of the Law No 30/1992 of 26 November shall be construed as including the following:

a) Authorization and major modifications of pharmaceutical laboratories.

b) Authorization for the import, export and manufacture of unregistered medicinal products.

c) Exceptional authorization to export medicines for humanitarian donations.

d) Declaration of galenic innovation of therapeutic interest.

e) Authorization, modification and renewal of parallel import of medicinal products.

f) Authorisation of medicinal products by decentralised procedure between European Union States.

2. The procedure for the registration and authorisation of medical devices not included in the scope of Royal Decree 1616/2009 of 26 October, governing the active implantable medical devices, and the Royal Decree 1591/2009, of 16 October 2009, for which medical devices are regulated, as laid down in the additional twenty-ninth provision of Law 14/2000, of 29 December, is excluded from the derogation provided for in Article 43.1 of Law 30/1992, of 26 November.

Additional provision 15th. Renewal of authorization of medicinal products.

The medicinal products for which authorisation has been renewed after the entry into force of Law 29/2006 of 26 July, shall apply to them, on the basis of that renewal, the rules in force in relation to the periodic reports of security.

Additional provision sixteenth. Application of the pricing system for medical devices authorised prior to the entry into force of Law 29/2006 of 26 July.

The medical devices authorised prior to the entry into force of Law 29/2006 of 26 July will have a maximum industrial price resulting from the application of the regulated price system in that law, based on their PVP. and discounting the marketing margins.

First transient disposition. Periods of data exclusivity applicable to applications for authorisation submitted before 1 November 2005.

The periods of data exclusivity for the reference medicinal products for which an application for authorisation had been submitted before 1 November 2005 shall be those which governed prior to the entry into force of the Regulation. Law 29/2006, of July 26.

Second transient disposition. Conflict of interest.

Without prejudice to compliance with the provisions of this law, and in particular to Article 4, pharmacists in professional practice with a pharmacy office, in retail establishment, in entities or groups (a) livestock or in a hospital pharmacy service and other care structures which, at the entry into force of Law 29/2006 of 26 July, have direct economic interests in approved pharmaceutical laboratories, may maintain such interests until the extinction of the laboratory authorisation or transfer.

Also, the pharmacists listed in the preceding paragraph who are a party or who may become part of cooperatives with a minimum of 20 cooperatives or commercial companies with a minimum of 100 shareholders or The partners, in both cases exclusively by those pharmacists and already existing at the entry into force of Law 29/2006 of 26 July, will be able to participate in them until their dissolution, provided that the same does not entail a possible conflict of interests.

Transitional provision third. Transient regime for the automatic identification of each drug unit along its route.

As long as the mechanism permitting the automatic identification of each unit of medicinal product along its route, in accordance with the provisions of Article 90, the pharmaceutical laboratories and the pharmaceutical laboratories, is not established. the distribution entities shall communicate in a timely manner to the Ministry of Health, Social Services and Equality, in the terms established by the Ministry by resolution, the batch data and the number of units sold or supplied, as well as those which are the subject of repayment, in national territory, specifying the (a) to be addressed, whether in the case of pharmacy offices or pharmacy or other distribution entities.

Final disposition first. Competence title.

This law is issued under the following State jurisdiction titles:

1. The preliminary title; Titles I; II, except Article 38; III; IV, except Articles 67 to 70 of Chapter II; V; VI; Articles 77.2, 78, 80 to 82, 84 and 87 to 90 of Title VII; Articles 93 to 99 of Title VIII; and IX; The first, second, seventh, eighth, thirteenth, fifteenth and sixteenth and transitional provisions have the status of legislation on pharmaceutical products and are given in accordance with Article 149.1.16. Constitution.

2. Articles 38, 67 to 70, 77.1, 3, 4 and 5, 79, 83, 85, 86, 100 and 104 to 107 and the additional third, fourth, ninth and twelfth provisions, have the status of basic rules and are dictated by Article 149.1.16. Constitution, which attributes to the State exclusive competence in the field of bases and general coordination of health.

3. Articles 91, 92 and 101 to 103, as well as the fifth and sixth additional provisions, are given in accordance with Article 149.1.17. of the Constitution, which confers exclusive competence on the State on the economic system of security Social.

4. Title X is issued under Article 149.1.6. of the Constitution, which gives the State exclusive jurisdiction in matters of procedural law.

5. Title XI is issued under Article 149.1.14. of the Constitution, which confers exclusive competence on the State in matters of the General Finance.

Final disposition second. Regulatory development.

The Government, in the field of its powers, is authorised to approve the regulations and standards for the application and development of this law.