JOHN CARLOS I

KING OF SPAIN

To all who present it and understand it.

Sabed: That the General Courts have approved and I come to sanction the following law.

EXPLANATORY STATEMENT

I

Law 25/1990 of 20 December of the Medicamento was intended, as stated in his explanatory statement, to provide the Spanish company with an institutional instrument that would allow it to wait confidently for the problems In the context of the development of the European Community, the Commission has been in the process of improving the quality of the information society. health care. The 15 years since the adoption of this Law have made it possible to state that the aim of the pharmaceutical provision as a universal provision has been largely achieved.

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

It is necessary to make a positive assessment of what drugs and medical devices are and represent for the National Health System, so the pharmaceutical policy developed during this period has been oriented in the direction of ensuring their availability to meet the needs of patients. Over the years, the health decentralization provided for in the General Health Law of 1986 has been completed and, since the beginning of 2002, all the Autonomous Communities have assumed the functions that they have been carrying out and the services they provide. which was provided by the National Institute of Health, which implies a complete decentralization of the health care of the National Health System, including that of the pharmaceutical provision.

In recent years the role of industry professionals has been instrumental in 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, as well as on 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 current challenge is 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 which the central objective is that all citizens continue to have access to the medication they need, when and where they need it, in conditions of effectiveness and safety.

II

During these years, the modification of the legal configuration and the composition of the structures of the European Union, forced by the new challenges and emerging needs, has affected the regulation, among others, of the sector pharmaceutical, forcing our country to review the current internal regulations. For this reason, Directive 2004 /27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001 /83/EC establishing a Community code is incorporated in this Law into our legal system. on medicinal products for human use, and Directive 2004 /28/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001 /82/EC establishing a Community code on veterinary medicinal products. In addition, the harmonization of our rules with Regulation (EC) No 726/2004 laying down the Community procedures for the authorisation and control of medicinal products for human and veterinary use and for which it is necessary is also ensured. the European Medicines Agency is established.

The experience derived from the application of Law 25/1990 has highlighted the need to intensify the orientation of the reform around two ideas-force: the extension and strengthening of a system of guarantees that will in relation to the authorisation of the medicinal product and the promotion of the rational use thereof. It is to be noted that the aforementioned law already referred to the first of them in establishing the requirement for quality assurance, safety and efficacy of medicinal products. However, technological development, globalisation and access to information, as well as the plurality of agents which are progressively involved in the production, distribution, dispensing and administration of medicinal products, advise at the moment, in addition to stepping up these safeguards, to extend them to the transparency and objectivity of the decisions taken and to the monitoring of their results.

The transfer of powers to the Autonomous Communities in the field of health initiated prior to Law 25/1990 of 20 December has been extended and extended to all Autonomous Communities after the The entry into force of the Law. The management of the Autonomous Communities in the field of health includes a wide range of policies regarding priorities in the treatment of health problems, introduction of new technologies and new treatments, promotion of more 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 systems and economic incentives health professionals and health centres, all within the broad scope of the exercise of the competences assumed in the framework of the criteria established by Law 16/2003, of Cohesion and Quality of the National Health System, and other state regulations on the subject.

In addition, the Strategic Plan for Pharmaceutical Policy for the National Health System establishes several strategies that are incorporated in this Law to intensify the rational use of drugs, among which can be noted The aim is to provide quality, regular and independent information to professionals, to ensure the rational use of medicinal products to health professionals, to the strengthening of the requirement of a medical prescription as a document which is essential for the patient's safety or those relating to the modification of the (a) the prospects for medicinal products to make them intelligible to the public, helping to 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 System to guarantee to healthcare professionals that the information, training and commercial promotion of the drugs have as core elements of their development the scientific rigor, the transparency and ethics in the practice of these activities.

Although the drugs have contributed decisively to the improvement of the hope and the increase in the quality of life, sometimes they pose problems of effectiveness and safety that must be known by the professionals which is particularly relevant to the role that this Law gives to the Spanish system of pharmacovigilance of the National Health System, with a more innovative approach, incorporating the concept of pharmacoepidemiology and risk management, and the guarantee of continued monitoring of the benefit/risk balance of authorised medicinal products.

The next few years draw a picture with a sensitive increase in population, a marked ageing of the population and, therefore, 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 have to be carried out necessarily in strategies for the rational use of drugs and for the control of pharmaceutical expenditure, which 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 in the light of the therapeutic usefulness of the drugs and their need to improve the health of the citizens.

The reference price system is also modified in this Law to enable the necessary savings to the National Health System and to ensure predictability, stability and graduality in the impact for the industry. pharmaceutical, affecting all drugs in a mature stage in the market.

The appearance in these years of generic drugs, proven and more economical clinical efficacy products, when the data exclusivity period of the original drug has expired, ensures identical conditions of quality, safety and efficiency at a lower price. Therefore, in this objective of sustainability, the measures incorporated in this Law aim to remove the obstacles that make it more difficult for these drugs to be present on the market, equating the Spanish situation with that of other countries of our environment.

This Law addresses all of these elements and incorporates relevant developments into the pharmaceutical supply, the most relevant of which are listed below.

III

Title I addresses the general provisions of the Law, precisely defining its scope, extensive to both human and veterinary medicinal products, and the guarantees of supply and supply that have to procure pharmaceutical laboratories, wholesale warehouses, pharmacy offices and other operators in the sector. Particularly novel is the regulation of guarantees of independence of professionals in the sector, which basically translates into a more precise definition of the assumptions in which conflicts of interest can arise, of which it is faithful reflection the prohibition of granting any incentive, bonus, disallowed discount, premium or gift from those who have direct or indirect interests in the production, manufacture and marketing of medicines and medical devices. As Directive 2001 /83/EC recognises, it should not be allowed to grant, offer or promise to persons empowered to prescribe or dispense medicinal products and in the framework of the promotion of medicinal products in the face of such persons, premiums, pecuniary advantages or benefits in kind. The title is closed with rules on the protection and protection of public health and collaboration and interadministrative participation.

IV

Title II, "From Medicines", includes in six chapters the regulation of all aspects related to the same.

Chapter I deals with a number of changes that are brought about by the directives mentioned above, including the abandonment of the concept of a pharmaceutical specialty on which Spanish legislation has been established, and which affects the definition of legally recognised medicinal products, the new definition of medicinal products for human use, the concept of harmonised generic in the European Union and the incorporation of the definition of a veterinary medicinal product.

Chapter II incorporates European criteria for the protection of innovation, research and development, in order to collaborate in promoting the competitiveness of the sector in Spain. Of particular importance is the new system of data exclusivity, diverse and fully respectful with the necessary protection of intellectual and industrial property associated with innovation, while promoting the rapid availability of generics in the market. According to the same, the applicant for a generic product may submit the application for authorisation after eight years at least since the reference medicinal product was authorised in any Member State of the European Union, make it possible to carry out the administrative evaluation and processing for authorisation, while ensuring compliance with the harmonised period of exclusivity of innovation data by establishing that it will not be able to market the product up to ten years, or 11 years if it obtains an additional indication for clinical benefit significant compared to existing therapies.

This protection regime is complete, as it could not be otherwise, with the incorporation, for clarification purposes, through the timely modification of the Law of Patents, of the so-called "Bolar clause or stipulation", according to the which is not considered to be a violation of the patent right for experimental purposes of the studies and trials necessary for the authorisation of generic medicinal products. In addition, the authorisation is incorporated to open up the possibility of introducing branded generic medicines into the market as a result of the new European regulation.

It is also important to incorporate the concept of "health care" related to the qualification of medications as non-prescription drugs. It is a question of adapting the wording of the Law to the social reality of the 21st century, in which the use of medicines without prescription in the conditions that are established, but which must be carried out in the framework of a use, is increasingly important. The rationale of the drug, for which the role of the pharmacist in everything related to responsible self-medication is essential.

Chapter III regulates veterinary medicinal products, which is a real novelty of the law, which welcomes a conception of these drugs away from the consideration of special medicines. They are regulated as medicinal products with their own characteristics, since, for the purposes of the European Community legislation implementing them, the abovementioned medicinal products must comply with the general guarantees of quality, safety and efficacy for the safeguarding the health and welfare of animals, as well as public health. For this reason it has been considered necessary to incorporate into law a chapter where the fundamental aspects of these medicines are specifically regulated.

The requirement for veterinary prescription prior to the supply of medicinal products for food-producing animals is also incorporated as a general rule and the Spanish pharmacovigilance system is regulated. veterinary medicinal product, as required by Directive 2001 /82/EC imposing the necessary reinforcement of pharmacovigilance systems.

Chapter IV refers to the health guarantees of the official formulas and the official preparations. The first ones are prepared with substances of action and indication legally recognized in Spain in the offices of pharmacy and legally established pharmaceutical services that have the necessary means for their preparation. Official preparations must meet certain conditions, including the need to present and dispense with the active substance, international non-proprietary name (INN) or, failing that, a common or scientific name and no case under commercial brand.

Chapter V regulates the health guarantees of special medicinal products, understanding as such those medicines that for their particular characteristics require specific regulation. This category includes vaccines and other biological medicinal products, medicinal products of human origin, advanced therapy medicinal products, radiopharmaceuticals, medicinal products with psychoactive substances with addictive potential, medicinal products and medicinal products. homoeopathic, the medicinal plants and the medicinal gases. From among all of them, it should be highlighted to cell therapy drugs. The text seeks to clarify that the law and the European legislation on guarantees and conditions of authorization will apply only to those that are manufactured industrially; the rest of the medicinal products, which are not destined for industrial production, where the characteristics and conditions laid down in the definitions of 'gene therapy medicinal product' or 'somatic cell therapy medicinal product' are present in them, they shall be regulated by regulation as determined.

In the field of pharmacovigilance, both for medicinal products for human use and for veterinary use, Chapter VI regulates public health activities aimed at identifying, quantifying, assessing and preventing risks. the use of the medicinal products once marketed, thus allowing for the monitoring of their possible adverse effects, of highlighting the Spanish system of pharmacovigilance, in which the health administrations need to carry out the necessary collect, compile and, where appropriate, process all the information useful for the monitoring of medicines and, in particular, information on adverse reactions to them, as well as for the performance of any studies considered necessary to assess their safety.

V

Title III regulates, under the heading "guarantees of the investigation of medicinal products for human use", clinical trials with medicinal products. It highlights the possibility that the health administration may publish the results of the clinical trials as a novelty, and as a guarantee of transparency, when such publication has not been carried out by the sponsor of the clinical trial; provided that the results allow to conclude that the product presents modifications of its efficacy or safety profile; and this, because it takes into account the interest which, both for the patients who have participated in the The results of the study, such as for doctors and for the general population, are in order to be able to know the results of the study. If it is derived that the medicinal product poses problems of efficacy or safety. In addition, the system of prior administrative authorisation is maintained, respecting the fundamental rights of the person and the ethical postulates affecting biomedical research, and the need for compliance with the standards of good practice. Clinical conditions are essential to ensure the suitability of the test. In the same way, compensation guarantees are maintained for subjects who may be harmed by their participation in clinical trials by requiring the prior assurance of the damages which may result from the those.

On the other hand, the Law empowers the Ministry of Health and Consumer Affairs to develop actions to enable the Ethical Research Committees accredited by the Autonomous Communities to share standards of adequate and homogeneous quality and evaluation criteria in the National Health System as a whole.

VI

The innovations introduced in Chapter I of Title IV are oriented, as required by the Community rules of application, to ensure the quality of medicinal products for human and veterinary use available on the market, demanding that the principles of good manufacturing practice for these medicinal products be respected.

Therefore, administrative authorization is incorporated into this law for entities that manufacture medicinal products for export and for which they manufacture intermediate products, as well as the obligation for the manufacturers of principles assets used as raw materials to comply with the correct manufacturing standards. For their part, the laboratories shall only use, as raw materials, active substances manufactured in accordance with the detailed guidelines in the rules for the correct manufacture of such raw materials.

Chapter II strengthens the obligations of wholesale warehouses, in particular in the area of supply. The Law allows the use of these intermediaries that allow the arrival of the medication to any part of the territory in a minimum time, which allows to guarantee the access of the citizen to the medication when needed. Precisely for this reason, they must assume a series of obligations with the National Health System, among which it should be noted that it is continuously supplied. In addition, they must have local and precise means, ensure compliance with the general or particular conditions for the preservation of medicinal products, maintain minimum stocks, ensure delivery times, minimum frequency of deliveries, comply with guard and disaster prevention services, etc.

VII

Title V is dedicated to the health guarantees of the foreign trade of drugs, an area that in an increasingly globalized framework is gaining a greater relevance. Imports and exports and the arrangements for medicinal products for the treatment of travellers are regulated in this Title.

VIII

Title VI is dedicated to the rational use of drugs, a principle that is concrete in measures such as a new regulation of the medical prescription or the prohibition of the activities related to the process of placing on the The market for a medicinal product is intended to increase the physical capacity of sportsmen and women. In relation to the medical prescription, it is noteworthy that the provision of the Law, which attributes to the doctor or dentist exclusively the ability to prescribe medication, tends to eradicate undesirable practices. The medical prescription is a genuine guarantee of professional service for the patient, so the pharmacist will dispense with prescription those medicines that require it and will not be able to prescribe for itself a medicine that requires prescription, but if you collaborate in the pharmacotherapeutic follow-up of prescribed treatments, through the procedures of the pharmaceutical care.

The Law contains a precise and concrete regulation of traceability obligations. The obligation is imposed, both to laboratories and to wholesale warehouses and pharmacy offices, to ensure the proper traceability of the medicinal products, as a measure that helps to avoid eventual supply and to supply a precise information on the ultimate destination of medicinal products marketed in Spain. As Directive 2004 /27/EC recognises, it is necessary to control the whole range of the distribution chain of medicinal products, from their manufacture or their import to their dispatch to the public, in such a way as to ensure that the medicinal products are preserved, transport and manipulate under appropriate conditions. The provisions to be adopted for this purpose will considerably facilitate the withdrawal of the defective product market and will enable the fight against fraudulent imitations to be combated more effectively.

On the other hand, measures are taken that aim to strengthen the policy of promoting generic medicines as established in the Strategic Plan for Pharmaceutical Policy.

IX

Title VII is dedicated to the public funding of medicines. It regulates the system of fixing and reviewing industrial prices and distribution and dispensing margins, incorporating, as a criterion for price fixing, the assessment of the therapeutic utility of the medicinal product and the degree of innovation, the effective implementation of the principle of selective financing of medicinal products, a principle which should inspire the incorporation of all medicinal products into the National Health System.

In order to guarantee maximum objectivity in the price fixing, the reports on the therapeutic use of the medicines to be prepared by the Spanish Agency for Medicines and Health Products will be taken into consideration. collaboration of a network of independent experts of recognised scientific prestige proposed by the Autonomous Communities.

One of the novelties of this title is the modification of the reference price system. This system of control of pharmaceutical expenditure is common in the countries of our environment. However, in the experience of its implementation in our country, in recent years deficiencies have been detected in its design that with this model are attempted to alleviate. It incorporates as most relevant novelties the graduality in its impact, the objectivity, in affecting all the drugs with more than ten years in the market or eleven if they have had any new indication, and their predictability, which determines the configuration of a predictable framework for the pharmaceutical industry in our country.

Finally, the application of the regulations on medicinal products to medical devices, which are financed with public funds, is available, through the official prescription of the National Health System, in national territory.

X

Title VIII of the Law is dedicated to the sanctioning regime in pharmaceutical matters, adapted to the current circumstances of the sector and pending revision since 1990. Therefore, on the basis of both the recent Community legislation and the internal administrative procedure and the experience gained, it is considered necessary to adapt the catalogue of infringements by amending the some behaviors and creating new types of sanctioned behaviors.

Among the most important modifications, some new ones are incorporated, such as selling drugs subject to medical prescription through the Internet, falsifying drugs, not communicating, by the pharmaceutical laboratories, wholesale warehouses and pharmacy offices, to the competent health authorities, the units of medicinal products sold for dispensing on national territory; failure to comply with the requirements which, for the completion of the medical visit, establish the rules of the Autonomous Communities; failure to comply with the sponsor or investigator of a clinical trial, the obligations laid down in the legislation in force or the rules of good clinical practice, as well as the conduct of a clinical trial without complying with the approved protocol or the non-compliance by the holder of the clinical trial marketing authorisation for the submission of periodic safety update reports.

Other infringements are aggravated by their classification, as is the case with the modification, by the holder of the authorization, of any of the conditions under which it was granted; the direct or indirect offer and the acceptance of any kind of incentive, bonus, disallowed discount, bonus or gift, made by those who have direct or indirect interests in the production, manufacture and marketing of medicines,/of professionals (a) the health of the person concerned by the prescription, dispensing and administration of the same; relatives and persons of their co-existence or not to have the entities of distribution and supply of stocks of medicinal products suitable for the normal provision of their activities or services.

XI

Title IX incorporates the action of cessation, a procedural measure imported, by express requirement of Directive 98 /27/EC of 19 May 1998 on European Community law and designed for those cases in which advertising of a medicinal product for human use is contrary to the content of the Law or its development provisions, affecting the collective or diffuse interests of consumers and users. The main objective of the measure is to obtain an end to the activity contrary to the above rules and to prohibit its future reiteration.

XII

Title X includes the regulation of fees for the services provided by the Administration in the material field of the Law. This title should be modified to the need to bring it into line with the provisions of Law 4/2004 of 29 December 2004 on the modification of taxes and tax benefits of events of exceptional interest.

XIII

Finally, the text regulates, in its sixth additional provision, the contributions to the National Health System by the laboratories, calculated on the basis of their sales volume. These contributions are intended for research in the field of biomedicine and for the development of health cohesion policies and training programmes for medical and pharmaceutical doctors and for the health education of the population. promote the rational or responsible use of medicinal products.

TITLE I

General provisions

Article 1. Scope of the Law.

1. The Law regulates, in the field of competencies that correspond to the State, the medicinal products for human use and medical devices, their clinical research, their evaluation, authorization, registration, manufacture, elaboration, quality control, storage, distribution, circulation, traceability, marketing, information and advertising, import and export, prescription and supply, monitoring of the benefit-risk relationship, as well as the management of its rational use and the procedure for, where appropriate, the financing of public funds. The regulation also extends to the substances, excipients and materials used for their manufacture, preparation or packaging.

2. It also regulates the action of natural or legal persons as they intervene in the industrial or commercial circulation and in the prescription or dispensing of medicinal products and medical devices.

3. It also regulates the Law on the general criteria and requirements applicable to veterinary medicinal products and, in particular, to special requirements, such as master formulae, and those relating to industrially manufactured products, including premixtures for medicated feed.

Article 2. Supply and dispensing guarantees.

1. Pharmaceutical laboratories, wholesale warehouses, importers, pharmacy offices, pharmacy services of hospitals, health centres and other health care structures are obliged to supply or to dispense medicinal products 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 109.1 of this Law, '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 medical prescription is prohibited. The implementing rules shall regulate such arrangements for sale in respect of medicinal products not subject to medical prescription, in any event by ensuring that they are dispensed by authorised office of pharmacy, with the intervention of a pharmacist, prior to any personalized advice as provided for in Articles 19.4 and 84.1 of this Law, and with compliance with the regulations applicable to medicinal products for sale.

It is also prohibited to sell at home and any type of indirect sale to the public of medicinal products.

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 regulations will lay down the requirements so that they can be sold directly to medical, dental and veterinary professionals only the medicines necessary for the exercise of their activity. professional.

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 monitoring, monitoring and control of the multidisciplinary health care team.

Article 3. Guarantees of independence.

1. Without prejudice to the incompatibilities laid down for the exercise of public activities, the clinical practice of medical, dental and veterinary medicine shall be incompatible with any kind of direct economic interest derived from the manufacture, manufacture, distribution and marketing of medicinal products and medical devices.

2. Likewise, the professional practice of the pharmacist in the office of pharmacy or in a hospital pharmacy service and other care structures shall be incompatible with any kind of direct economic interests of the laboratories. pharmacists.

3. The clinical practice of medicine, dentistry and veterinary medicine shall be incompatible with the performance of professional activity or with the ownership of a pharmacy office.

4. 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 or consultative bodies established by the Health Administrations of the Communities Autonomas 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 pharmaceutical laboratories.

6. For the purposes 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 your coexistence. This ban will also apply when the offer is made to healthcare professionals who prescribe medical devices. Except for the previous prohibition, discounts for early payment or purchase volume, which are made by distributors to the pharmacy offices, provided that the purchase of a product is not incentivised against its competitors and they remain reflected in the corresponding invoice.

Article 4. 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, are 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. Failure to comply with the above prohibitions shall give rise to the responsibilities and penalties provided for in Chapter II of Title VIII of this Law, irrespective of the precautionary measures and the civil or civil liability. penalties to be taken.

Article 5. 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 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 be in accordance with the provisions of the provisions in force.

Article 6. 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 medications recognized by the Law and its classes

Article 7. 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) The 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 their general control of 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 of which the composition and characteristics are unknown 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.

Article 8. 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 with the the purpose of restoring, correcting or modifying physiological functions by exercising pharmacological, immunological or metabolic action or establishing a veterinary diagnosis. 'Veterinary medicinal products' shall also be considered as 'medicated feed premixtures' prepared to be incorporated into a feed.

(c) "active substance" means any matter, whatever its origin-human, animal, plant, chemical or other-to which an appropriate activity is attributed to constitute a medicinal product.

(d) "Excipent" means any matter which, included in the galenic forms, is added to the active principles or to their associations to serve them as a vehicle, to enable their preparation and stability, to modify their properties organoleptic or determine the physicochemical properties of the medicinal product and its bioavailability.

(e) "Raw material" means 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) 'Gallic form or pharmaceutical form' means the arrangement 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" means 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" means a product intended for further industrial processing by an approved manufacturer.

(i) "masterful formula" means the medicinal product intended for an individual patient, prepared by a pharmacist or under his/her management, 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" means 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 at the office of 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 placebo, which 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 manner other than that authorised, or when used to treat an unauthorised indication, or for more information on an authorised use.

(l) "Health product" means any instrument, device, equipment, material or other article, used alone or in combination, including software which is operated by the manufacturer; to be used in humans for the purpose of:

1. 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 hygiene product" means substances or preparations 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 preparation intended to be brought into contact with the various superficial parts of the human body (epidermis, hair and hair system, nails, lips and external genital organs) or with the teeth and mouth mucous membranes, for the sole or main purpose of cleaning, perfuming, modifying their appearance, and/or correcting body odours, and/or protecting them or keeping them in good condition.

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 previous paragraph, any dosage, pharmaceutical form, route of administration and additional presentations, as well as any other modifications and extensions which are introduce, they must be subject to authorisation. All such authorisations 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 Minister for Health and Consumer Affairs shall lay down the type of checks required from the marketing authorisation holder and the manufacturer to ensure the quality of the raw materials, intermediate products, the process of the manufacture and 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 and Consumer Affairs 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 Royal Spanish 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 and Consumer Affairs 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 these programmes, in the framework of the Interterritorial Council of the National Health System, unit criteria shall be established for the extent, intensity and frequency of the checks to be carried out.

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 wholesale warehouses are required to work diligently in the knowledge of product safety. In addition, healthcare professionals, pharmaceutical laboratories and wholesale warehouses are obliged to communicate to the health authorities the anomalies of which they were notified, 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 (D.O.E.) 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 (D.C.I.) 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 a fantasy which cannot be confused with the common name, or a common or scientific name accompanied by a trade mark or the name of the holder of the authorization marketing.

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 the scientific substance of the substance, accompanied, where appropriate, by the name or mark of the holder or manufacturer. They will also be identified with the acronym EFG (Generic Pharmaceutical Equivalent).

The name of the medicinal product, where it is a trade name or a trade mark, cannot be confused with a Spanish official name or an international name or be misleading on the basis of therapeutic properties. or the nature of the medicinal product.

3. The Ministry of Health and Consumer Affairs will establish a National Drug Code of general application that facilitates its early identification and may require that its numbers or keys appear on the labelling of the drugs.

Article 15. Information guarantees.

1. The Ministry of Health and Consumer Affairs shall regulate matters relating to information guarantees: characteristics, extent, details and places where it is 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.

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, precept, by up-to-date information on the price of the medicinal product, and, where possible, the cost of the treatment.

The Spanish Agency for Medicines and Health Products shall make the technical information available to the health services of the Autonomous Communities, of the professional associations or organizations, of the doctors, dentists and (a) a working pharmacist and, where appropriate, a veterinary surgeon in practice. 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 advertising medicinal products, the receipt shall also contain the discount which, where appropriate, would have 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 its amendments: 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 collegiate bodies of technical and scientific advice of the Ministry of Health and Consumer Affairs related to the authorisation of medicinal products, their modifications, suspensions and revokes.

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 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 period of 10 years 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 authorisation of the reference medicinal product 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 package leaflets and the labelling of medicinal products which do not require medical prescription shall contain such warnings as are appropriate to their nature and, in particular, to prevent their misuse.

6. The Ministry of Health and Consumer Affairs shall lay down the minimum requirements, characteristics and time limits for the validity of medical prescriptions and hospital prescriptions, as well as the special requirements for the prescription and dispensing of medicinal products. psychoactive substances and others which by their nature require it or for peculiar 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 may authorise, under the conditions laid down in regulation, the supply of specific units of medicinal products for the purpose of care for certain patients whose clinical situation and duration of treatment so requires. 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.

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 risk benefit 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 the case of which the Spanish Agency for Medicinal Products and Health 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 in this Law are not carried out.

b) When, on the basis of the safety data, the medicinal product has, under the usual conditions of use, 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.

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 set out in this Law for the inclusion of drugs in that provision.

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

The Spanish Agency for Medicinal Products and Sanitary Products may modify the authorization of medicinal products that require it for reasons of public interest or defense of the health or safety of persons.

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 which as required 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 treatment of specific patient clinical situations 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 Minister of Health and Consumer Affairs shall lay down the conditions for the prescription of authorised medicinal products when used under conditions other than those authorised, which shall in any case 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.

CHAPTER III

Of the guarantees required for 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 standards, which lay down 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 Medicinal Products and Sanitary Products shall act in accordance with the criteria laid down by the Ministry of Agriculture, Fisheries and Food and in accordance with the 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 which are introduced, shall be subject to authorisation and shall form part thereof.

3. Any modification, transmission and termination of the authorisations of veterinary 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 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, which do not require a 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 and Consumer Affairs, in coordination with the Ministry of Agriculture, Fisheries and Food, shall establish the type of checks required from the marketing authorisation holder and the manufacturer to ensure the the quality of raw materials, intermediate products, the manufacturing process and the final product, 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 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. Medicinal products for veterinary use 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 wholesale warehouses are required to work diligently in the knowledge of product safety. In addition, healthcare professionals, pharmaceutical laboratories and wholesale warehouses are obliged to communicate to the health authorities the anomalies of which they were notified, 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, also 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 (D.O.E.) in accordance with Article 14 of this Law.

2. A veterinary medicinal product may be designated with a trade mark, or with 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 Medicinal Products for the general application of veterinary medicinal products, which shall facilitate their early identification and may also require their numbers or keys to be included in the packaging, labelling and packaging of veterinary medicinal products.

Article 31. Information guarantees.

1. The Ministries of Agriculture, Fisheries and Food and Health and Consumer Affairs shall regulate the aspects relating to the guarantees of information: characteristics, extension, details and places to be included. In any case, the holder shall provide sufficient written information on the identification, indications and precautions to be taken in his employment for the purposes of drawing up 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.

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 Medicines and Health Products will make the technical information available to the Autonomous Communities, to the schools or professional organizations, and to the veterinarians and pharmacists in 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 regulation 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 its amendments: 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 authorisation of any modifications to the initial authorisation.

2. The Spanish Agency for Medicinal Products and Sanitary Products may require the applicant to provide documentation, studies, data or supplementary 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, Fisheries and Food, shall, for the purposes of the issuing of the reports, correspond to, with committees or advisory bodies incorporating qualified experts from the Autonomous Communities and 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 Sanitary Products, or in its the case of another national laboratory accredited for that purpose by the Agency itself, or an official Community or third country 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 literature-scientific literature, if it can demonstrate that the active substances of the Veterinary medicinal product has had a well established veterinary use for at least ten 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. Granted the authorisation of a veterinary medicinal product, any modification requested in connection with the veterinary medicinal product shall be duly documented in accordance with the rules laid down.

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 Health Products or the Autonomous Communities may at any time require the pharmaceutical laboratory to justify the performance of the quality checks and the number of others 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 medicinal products for veterinary use, in which the Ministry of Agriculture, Fisheries and Food shall 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 risk benefit 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 to avoid unnecessary risks to the species to which they are intended, to the person administering such medicinal products to animals and to 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 and Consumer Affairs after consulting the Ministry of Agriculture, Fisheries and Food may derogate from this requirement in accordance with the decisions taken by the European Commission in this field.

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 of this Article shall be placed on the market

referred to in paragraphs (a), (c) and (f)

5. The veterinary prescription shall be valid throughout the national territory and shall be published in the official language of the State and in the respective co-official languages in the Autonomous Communities. 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.

Regulated the professional performance of the pharmacist in each of the establishments described above in point (c) as a condition and requirement to ensure effective control in the supply to the (a) the public of veterinary medicinal products, taking into account the number of pharmacists necessary in the light of the activity of the establishments concerned.

However, medicinal products intended for 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 and Consumer Affairs, in agreement with the Ministry of Agriculture, Fisheries and Food, shall, on an exceptional basis, regulate the use of medicinal products by veterinary medicinal products in the 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, on request and a mandatory report of the Ministry of Agriculture, Fisheries and Food, 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 medicinal products for veterinary use.

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 is coordinated by the Spanish Agency for Medicines and Health Products and as provided for in Article 57 of this Law, will be regulated. activities carried out by the Health Administrations to collect and develop information on adverse reactions to medicinal products for veterinary use.

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 of this Law 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 and pharmaceutical offices which do not have the necessary means, exceptionally and without prejudice to the provisions of Article 67.2, may entrust an entity with those provided for in this Article. Law, authorized by the competent health administration, the carrying out of one or more phases 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. For the masterful formulation of substances or medicinal products not authorised in Spain, the arrangements provided for in Article 24 of this Law shall be required.

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 from the pharmacy office, or from the pharmaceutical service that disfigured them.

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

e) Official preparations 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.

2. Exceptionally, and without prejudice to Article 67.2, pharmacy offices and pharmaceutical services which do not have the necessary means may entrust to a body legally authorised for that purpose by the Administration. competent health care, the performance of one or more stages of the preparation and/or control of, exclusively, those formal preparations which meet 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 own 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 regulentarily 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, shall be carried out in 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 countries of the European Union that 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 of this Article.

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' is considered to be 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 established in the definitions of "drug therapy" gene "or" somatic cell therapy drug ", have not been manufactured industrially.

Article 48. Radiopharmaceuticals.

1. For the purposes of this Law:

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

b) Generator: any system that incorporates a radionuclide (radionuclide parent) that in its disintegration causes another radionuclide (radionuclide son) to be used as an integral part of a radiopharmaceutical.

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

d) Precursor: any 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 the second paragraph 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 the second paragraph may not be required for the preparation of PET (positron emission tomography) radiopharmaceuticals in an approved radio-arm 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 Spanish or, failing that, in a pharmacopoeia used officially in a country 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 and Consumer Affairs shall establish a national code to facilitate its early identification and also require that its numbers or keys appear on the packaging, labelling and packaging of homeopathic medicinal products, with the same criteria as in other medicines.

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 and Consumer Affairs 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 freely sold to the public and offered without reference to therapeutic, diagnostic or preventive properties, their street sale being 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 2.6 of this Law, the operators, manufacturers, importers and marketing of liquefied medicinal gases may supply them, as determined by the competent health authorities, to the health care, social care centres 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 a duty to communicate with the pharmacovigilance competent bodies of each Autonomous Community the suspected adverse reactions of which they are aware and which may have been caused by medication.

3. The authorisation holders are also required to inform the health authorities of the Autonomous Communities of the suspected adverse reactions of which they are aware and which may have been caused by the medicinal products which manufacture or market, in accordance with 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.

4. The Autonomous Communities will transfer the information received to the Spanish Agency for Medicines and Health Products.

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 the health professionals will participate in the performance of these studies and will collaborate in the dissemination of knowledge on the safety of 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 the guarantees of the investigation of medicinal products for human use

Article 58. Clinical trials.

1. For the purposes of this Law, clinical trials shall mean any research carried out in humans, in order to determine or confirm the clinical, pharmacological and/or other pharmacodynamic effects and/or to detect 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.

2. The health authorities should facilitate the conduct of the 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 transparency criteria, and as set out in this Act. 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.

3. Observational studies are not subject to the provisions of this chapter. For the purposes of this Law, it is understood by observational study the study in which the drugs are prescribed in the usual way, according to the conditions established in the authorization. The assignment of a patient to a specific therapeutic strategy will not be decided in advance by the protocol of an essay, but will be determined by the usual practice of the medicine, and the decision to prescribe a specific medication 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, and epidemiological methods will be used for the analysis of the data collected.

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 principles set out in Article 60 of this Law are not met.

d) To protect the health of test subjects, or

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 will also be able to perform the precautionary interruption of the test for any of the causes mentioned in the previous point, 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, as soon as possible, 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 the Ethical Committee of Clinical Research must be carried out in the 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, in accordance with which the authorisation would have been granted, as well as 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 conducted 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, following these effects. contained in the Helsinki Declaration.

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 clinical documentation, in the terms that are regulated.

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 and Consumer Affairs will develop actions to enable accredited clinical research committees to share quality standards and appropriate and homogeneous evaluation 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 those of fractionation, conditioning and presentation for sale, shall 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 necessary technical qualification to ensure the quality of the medicinal products and the execution of the controls provided 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 operating requirements set out in Article 70.1, 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, either to wholesale warehouses or to services or pharmacy offices, is carried out in compliance with both the obligations imposed on the authorisation of the medicinal products and the rules correct distribution of the 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 and Consumption 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 and Consumer Affairs, in accordance with the detailed guidelines on good manufacturing practice for raw materials established in the framework of the community.

Furthermore, the manufacturers of active ingredients used as raw materials must comply with the rules of correct manufacturing of raw materials, published by the Ministry of Health and Consumer Affairs. 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 8 of this Regulation. Law, as well as the various processes of division, conditioning and presentation prior to their incorporation into a medicinal product, including reconditioning and relabelling, performed by wholesale warehouses of raw materials.

The provisions of the preceding paragraph shall also apply to certain excipients. The list of these and the specific conditions for their use shall be approved by the Minister for Health and Consumer Affairs.

The pharmaceutical laboratory may only use as raw materials active principles manufactured in accordance with the detailed guidelines in the rules of correct raw material manufacturing.

3. 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.

4. 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.

5. 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) of this Law or the subject matter of the authorization 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. 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 67. 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 must have the authorization referred to in Article 63 of this Law.

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

2. Exceptionally and when it is necessary to care for its patients, the hospital pharmacy services and pharmacy offices may entrust to an entity legally authorized 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 68. Guarantees of accessibility and availability of medicines.

1. The distribution of the authorised medicinal products shall be carried out either through wholesale warehouses or directly by the laboratory that holds 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 a wholesale warehouse for the distribution of medicinal products shall be included in the relevant authorisation as a laboratory or a wholesale warehouse.

Article 69. Administrative control of the wholesale distribution.

1. Stores of wholesale distribution of medicinal products and medicinal substances to pharmacy offices and services shall be subject to prior authorization from the Autonomous Community where the company is domiciled. However, the undertaking must communicate the performance of its activities to the health authorities of the Autonomous Communities where, not being domiciled, such activities are carried out.

2. Without prejudice to the powers of the Autonomous Communities, the wholesale warehouse and, where appropriate, the laboratory holder of the marketing authorisation shall communicate directly to the Spanish Agency for Medicinal Products and Sanitary Products the start of their activities.

Article 70. Operational requirements.

1. Wholesale warehouses and, where appropriate, pharmaceutical laboratories which distribute their products directly will 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 paragraph 1 of this Article. The Government shall ensure the preservation of the right of the wholesale warehouse to be supplied by laboratories.

Article 71. Technical director.

Authorised wholesale warehouses shall have a pharmaceutical technical director whose charge shall be incompatible with other activities of a health nature which involve direct interest in the manufacture or supply of medicinal products or which are detrimental to the proper performance of their duties.

The government shall establish the functions of the technical director as well as, on a basic basis, the number of pharmaceutical professionals from which a wholesale warehouse must be available from a given volume of activity.

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 be in accordance with the requirements laid down in Title IV of this Law. For this purpose, the importer may use the pharmaceutical channels which are legally authorised to do so or to be placed in a wholesale warehouse after the corresponding authorization granted in accordance with Chapter II of Title IV of this Law.

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 inspection by the Ministry of Health and Consumer Affairs shall be provided.

4. The checks referred to in the previous paragraph shall be deemed to have been carried out in the case of the Ministry of Health and Consumer Affairs, which is documented in the country of origin, with the same requirements as those provided for in this Law, without prejudice to the obligations arising from membership of the European Union and other international treaties entered into 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 marketing 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. Medicinal products may be exported by wholesale laboratories and warehouses which comply with the legally established requirements.

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 in 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 set out in this Law on guarantees of information 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 appropriate measures to prevent the products covered by this Law, which are in 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 to participate in a sporting activity, to send duly completed forms to the Spanish Anti-Doping Agency, the forms which it establishes, in which the products they carry for their use, the units of the same and the the doctor responsible for his or her prescription or, in the case of animals participating in sporting events, the veterinarian.

TITLE VI

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 75. 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 76. 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 under the terms provided for in Article 102.1 of the General Health Law, must be in accordance with the technical and scientific authorised by the Spanish Agency for Medicinal Products and Sanitary Products and must 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 77. The prescription and hospital prescription.

1. The medical prescription, public or private, and the hospital order of dispensing, are the documents that ensure the establishment of a treatment with medication by instruction of a doctor or a dentist, only professionals with faculty to order prescription of medications.

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 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 earlier numbers and lay down the requirement for other requirements which, in the case of public health or the health system, must be applied in general to medical or medical prescriptions. hospital orders.

7. The procedures for the submission of prescriptions and medical orders and, in particular, in their processing, shall comply with the provisions of Article 10 of the General Health Law.

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 78. Guarantees in advertising for medicinal products 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.

Compliance with these requirements will be verified with prior approval by the Ministry of Health and Consumer Affairs through the granting of the mandatory authorization.

2. The Ministry of Health and Consumer Affairs shall require, for the purposes of its authorisation, that the advertising messages of the medicinal products 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. Health administrations may, for reasons of public health or safety, limit, condition or prohibit the advertising of medicinal products.

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

5. In the case of medical devices, the possibility of direct or indirect advertising directed to the public is excluded if a product is financed by the National Health System. 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 the like are prohibited as methods linked to the promotion or sale to the public of products.

Article 79. 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 80. Rational use of medicines in sport.

The import, export, distribution, marketing, prescription and dispensing of legally recognized medicinal products shall not be intended to increase the physical abilities of the athletes or to modify the results of the competitions in which they participate, with the need to adjust their development and objectives to the rules of application in this field.

CHAPTER II

From the rational use of drugs in primary health care

Article 81. 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 dispensing of the drugs to be applied within the primary care centres and those for which a particular surveillance, supervision and control is required, as provided for in Article 103 of Law 14/1986 of 25 April, General Health and 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 82. 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 dispensing of the drugs precise for intra-hospital activities and for those other, for extra-hospital treatment, requiring particular surveillance, supervision and control.

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 area's primary and specialized care structures in the development of the functions outlined in Article 81.

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 83. 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 must apply to the Autonomous Communities for authorization 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 84. 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 prescription, and will cooperate with the in the follow-up of treatment through the procedures of pharmaceutical care, contributing to ensure its efficacy and safety. They shall also participate in the implementation of the set of activities intended for the rational use of medicinal products, in particular through the informed dispensation of the patient.

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 85. Prescription for active substance.

Healthcare Administrations will encourage the prescription of drugs identified by their active substance in the prescription.

In cases where the prescriber simply indicates an active substance in the prescription, the pharmacist will dispense the lower-priced medicine and, in the case of equal pricing, the generic, if any.

Article 86. 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 bioavailability characteristics and narrow therapeutic range, shall be determined by the Ministry of Health and Consumer Affairs shall be exempted from this possibility.

CHAPTER V

Traceability of medicines

Article 87. Traceability guarantees.

1. In order to achieve adequate market supply and to provide security guarantees for citizens, laboratories, wholesale warehouses and pharmacy offices are subject to the reporting obligations referred to in Article 3 (1) of the Directive. this article.

2. The pharmaceutical laboratories shall, in the terms to be laid down in regulation, communicate to the Ministry of Health and Consumption the units of presentations identified by batches of medicinal products and consignee, sold on national territory, as well as those that are the subject of return. 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 of this Law.

3. Wholesale warehouses shall, in accordance with the terms to be laid down in regulation, communicate to the Autonomous Community where they have their registered office and to the Ministry of Health and Consumption the units supplied and the returned units, indicating the lot to which they belong as well as the consignee, whether they are offices or services of pharmacy or of other wholesale warehouses, 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 and Consumer Affairs, in accordance with the terms laid down in this Regulation.

5. 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 files of public ownership by the General Administration of the State, the competent health authorities of the Autonomous Communities and, where appropriate, the Corresponding corporate administrations.

TITLE VII

Public funding for medicines and medical devices

Article 88. Principle of territorial equality and coordinated procedure.

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 the exercise of their powers.

2. 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 89. Procedure for public funding.

1. Once authorised and registered a medicinal product, the Ministry of Health and Consumer Affairs by means of a reasoned decision shall decide, prior to its placing on the market, whether or not to include it in the pharmaceutical provision of the National System of Health. In case of inclusion, the modality of such inclusion shall also be decided.

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 financing 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 utility of the drug.

d) Rationalization of public expenditure for pharmaceutical provision.

e) Existence of medications or other alternatives for the same conditions.

f) The degree of innovation of the drug.

Without prejudice to the provisions of Article 24, the Ministry of Health and Consumer Affairs, in order to ensure the rational use of medicinal products, may subject, on its own initiative or at the request of the Autonomous Communities concerned, to reservations. the specific conditions of prescription, dispensing and funding of the same in the National Health System.

2. Groups, sub-groups, categories or classes of medicinal products or medical devices, the public funding of which is not justified or not deemed necessary, may not be financed from public funds. Advertising medicinal products, cosmetic products, dietetic products, mineral waters, elixirs, toothpaste and other similar products shall be considered, in any case, not included in the public financing.

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 preceding points and taking into account the price or the cost of the treatment of comparable medicinal products existing 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 previous numbers.

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 case, they must comply with the specifications and technical specifications which the Ministry of Health and Consumer Affairs has previously determined, taking into account general, objective and published criteria and in particular the following:

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 utility of the healthcare product.

Article 90. Pricing.

1. It is for the Council of Ministers, by royal decree, on a proposal from the Ministers of Economy and Finance, Industry, Tourism and Trade and Health and Consumer Affairs and with the agreement of the Government Delegation for Economic Affairs, to establish the general system for fixing the industrial prices of medicinal products, as well as for those medical devices which are to be included in the pharmaceutical provision of the National Health System and which are dispensed with, by means of an official prescription, on national territory, which shall meet objective criteria.

The economic amounts corresponding to the concepts of the distribution and supply of medicines and medical devices are fixed by the Government, after agreement of the Government's Delegate Committee for Economic matters, in general or by groups or sectors, taking into account technical and economic criteria.

2. In the context of the procedure for the financing of medicinal products with public funds as referred to in Article 89 of this Law, it is for the Inter-Ministerial Committee on Drug Prices, attached to the Ministry of Health and Consumer Affairs, to set out, on the basis of objective criteria, the maximum industrial price for medicinal products and medical devices to be included in the pharmaceutical provision of the National Health System, from public funds, and which shall be dispense, through official prescription, in national territory. In addition to the criteria laid down in Article 89.1, account shall also be taken of the average price of the medicinal product in the Member States of the European Union which, without being subject to exceptional or transitional property regimes (a) the relevant Community legislation would have been incorporated into its legal order.

3. The Inter-Ministerial Committee for the Prices of Medicinal Products will take into account the reports on therapeutic use of medicinal products to be prepared by the Spanish Agency for Medicines and Health Products. For the preparation of such reports, it will have a network of external collaborators consisting of independent experts of recognized scientific prestige, which will be proposed by the Autonomous Communities in the form to be determined regulentarily.

4. The Ministry of Health and Consumer Affairs shall establish the selling price to the public of medicinal products and medical devices by aggregation of the maximum industrial price and the concepts corresponding to the costs of marketing.

5. The industrial prices of medicinal products shall be free of medicinal products which are not financed from public funds, as well as in specific products, classes of products or therapeutic groups to be determined by the Government to be competence or other social and health interests as appropriate, without prejudice to any administrative intervention deemed necessary.

Article 91. Price revision.

1. The price fixed shall be reviewable 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 of the Legal Regime of Public Administrations and of the Administrative Procedure Common.

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, fixed in accordance with the provisions of the 90, for all or part of the medicines and medical devices in the 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. It shall not, except in the case referred to in paragraph 1 of this Article, review or modify the price of a medicinal product or medical device or group of medicinal products before a year has elapsed since the initial fixation or its modification.

Article 92. Economic information.

1. For the purposes of price fixing, pharmaceutical laboratories shall provide the Ministry of Health and Consumer Affairs 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 and Consumer Affairs may require the information to be provided by the company. imputation 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 and Consumer Affairs will annually raise a report on its pricing actions to the Government's Delegation for Economic Affairs.

Article 93. The Reference Price System.

1. Public funding for medicinal products shall be subject to the reference price system.

The reference price shall be the 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 through the official medical prescription of the National Health System.

2. All submissions of funded medicinal products having the same active substance and the same route of administration shall be understood as a whole, including at least one generic medicinal product presentation. The presentations indicated for treatments in pediatrics will constitute separate sets.

The Minister of Health and Consumer Affairs, prior to the agreement of the Government Delegation for Economic Affairs and the report of the Interterritorial Council of the National Health System, will determine, with the periodicity that it will regulate it is fixed, such sets, as well as their reference prices and may set minimum thresholds for these prices, in no case less than two euro. The reference price shall be, for each set, the arithmetic mean of the three lower costs/day/day of the presentations of medicinal products in the grouped by each route of administration, calculated according to the defined daily dose. The Ministry of Health and Consumer Affairs shall establish as necessary for the purposes of the application of that calculation formula.

Reglamentarily the assumptions, requirements and procedures in which certain gallic innovations that are considered to be of interest to add improvements in the therapeutic utility may be excluded from the reference price system for five years. After the five years, the Welsh innovation will be integrated into the reference set.

3. Generic medicinal products may not exceed the reference price of the corresponding set. In addition, the reference price may not exceed the presentations of medicinal products which do not have the same generic medicinal product presentations for the purposes of the substitution provided for in the following paragraph, as long as the situation is maintained. of unavailability.

4. The supply of products affected by the reference price system shall be made in accordance with the following criteria:

(a) Where a medicinal product is prescribed which is part of a package and has a price equal to or less than the reference price, the replacement shall not proceed except as provided for in Article 86.2.

(b) Where a medicinal product is prescribed which is part of a set and is higher than the reference price, the pharmacist must replace it with the lowest price and the same qualitative and quantitative composition in active substances, pharmaceutical form, route of administration, dosage and presentation as prescribed medicinal product and, in the case of equal price, by the generic medicinal product.

(c) Where the prescription is made on the basis of an active principle subject to the reference price, the pharmacist shall dispense the medicinal product with a lower price and, in the case of equal price, a generic.

5. Where, by application of the calculations of the reference price system regulated in this paragraph, the industrial price of a product is affected by more than 30%, the pharmaceutical laboratory may, where appropriate, choose to take on board the entire reduction in one year or at least 30% per year until the reference price is reached, according to the procedure to be determined in a regulated manner. In this second case the medicine will continue to be funded but will not be part of the reference price system until the entire downgrade has occurred.

6. Medicinal products in respect of which there is no authorised generic in Spain after 10 years from the date on which the decision to finance public funds or 11 was adopted in the event of a new indication being authorised, reduce its current price by 20% provided that it has been authorised in any Member State of the European Union which, without being subject to exceptional or transitional industrial property regimes, would have incorporated it into its legal system the relevant Community legislation with a generic medicinal product a lower price than the reference medicine in Spain. The minimum thresholds for exclusion of this measure may be set in no case less than two euro.

7. In addition, medicinal products for use in hospital for 10 years from the date on which the decision to finance public funds or 11 years had been adopted if a new indication was authorised for the purpose of the (a) medicinal product, non-generic, shall reduce its current price by 20% provided that it has been authorised in any Member State of the European Union which, without being subject to exceptional or transitional property regimes (a) the relevant Community legislation has been incorporated into its legal system; generic medicine with a lower price than the reference medicine in Spain. The minimum thresholds for exclusion of this measure may be set in no case less than two euro.

Article 94. Patients ' obligations.

1. According to the General Health Law, by means of a royal decree, prior to the Interterritorial Council of the National Health System, the Government may regularly regulate, when financed from the funds provided for in paragraph 1 of the Article 89, the cases in which the administration of medicinal products and medical devices shall be free of charge, as well as the participation in the payment to be paid by the sick for the medicinal products and medical devices provided by the System National of Health.

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 95. Assessment of the prescription.

In the field of the National Health System, it is up to the public health administrations to evaluate the prescriptions for areas, zones, therapies, population groups, and other circumstances. The Ministry of Health and Consumer Affairs will establish coordination mechanisms to identify the use of medicines and medical devices, optimize research into their evolution and adopt measures for information and promotion of use. 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 taken.

Article 96. 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 established in this Law and those that are determined in the development regulations, the pharmacy offices may be the subject of consultation in the National Health System, according to the general system of administrative procurement and in accordance with the general criteria referred to in Article 88.2 of this Law.

Article 97. Managing information about recipes.

The aggregated information resulting from the processing of the prescriptions of the National Health System is in the public domain, always saving the confidentiality of health care and commercial business data individualised. 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 as a whole.

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.

TITLE VIII

Sanctioning Regime

CHAPTER I

Inspection and precautionary measures

Article 98. 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) 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 99. 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.

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 100. General provisions.

1. The offences relating to medicinal products shall be subject to the appropriate administrative penalties, subject to the instruction of the appropriate file, without prejudice to any civil, criminal or other order which may be held.

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 the provisions of Title IX of the Law on the Legal Regime of Public Administrations and the Common Administrative Procedure, it will be applicable to the sanctioning regime.

Article 101. Violations.

1. The infringements shall be regarded as 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 set out in the following

:

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

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

6. Make advertising of master formulas or official preparations.

7. Incompliance with the requirements that, for the performance of the medical visit, establish the regulations of the Autonomous Communities.

8. Do not correctly fill in the data and warnings that must contain the normalized recipes.

9. Dispense Medications after the prescription is valid.

10. Perform the replacement of a drug, in cases where this is possible, in breach of the requirements laid down in this Law.

11. Incompliance with the requirements, obligations or prohibitions laid down in this Law and provisions that develop it in such a way that, by reason of the criteria referred to in this article, such breaches deserve The rating of a minor or not as a serious or very serious fault.

12. Do not include in the packaging of medicinal products the information in alphabet braille for correct identification by blind and visually impaired persons, in accordance with the provisions of Article 15 (5) of the Treaty. this Act.

b) Serious infractions:

1. Not to be carried out in the manufacture, manufacture, import, export and distribution of medicinal products for quality controls required by health legislation or to carry out manufacturing or control processes by means of procedures not validated.

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

3. To prevent the performance of duly accredited inspectors in the centres where medicinal products are manufactured, manufactured, distributed and dispensed.

4. To 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. Modify by the holder, without prior authorization, any of the conditions of authorization of the medicinal product.

7. No avail, a pharmaceutical or wholesale warehouse, 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 laid down in the legislation in force or the rules of good clinical practice, as well as the conduct of a clinical trial without adjusting to the protocol approved, where the fact, on the basis of the criteria referred to in this Article, does not merit the rating of a very serious fault.

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, wholesale warehouses or health personnel, the duty of pharmacovigilance.

15. Refuse to dispense medicines or medical devices without justified cause.

16. Unprescription medicines or sanitary products, when required.

17. To supply, purchase or sell medicinal products or medical devices 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 Information on the laboratories of medicinal products or medical devices.

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 With or provision of medicines or medical devices in establishments other than those authorised.

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 86 of this Law.

26. No act or omission aimed at coarking the freedom of the user in the choice of the pharmacy office.

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. First to offer directly or indirectly any incentive, bonuses, prohibited discounts, premiums or gifts, made by those who have direct or indirect interests in the production, manufacture and marketing of medical devices, to healthcare professionals, on the occasion of their prescription, or to their relatives and people of their coexistence.

29. AOK, healthcare professionals, on the occasion of the prescription, dispensing and administration of medicines and/or medical devices from the National Health System, or their relatives and persons from their coexistence, any incentive, bonus, prohibited discounts, premiums or gifts made by those who have direct or indirect interests in the production, manufacture and marketing of medicinal products and medical devices.

30. Do not communicate pharmaceutical laboratories to the Ministry of Health and Consumer units of medicines sold to be dispensed on national territory.

31. Failure to report wholesale warehouses to the health authorities of the Autonomous Communities in which they have their registered office and to the Ministry of Health and Consumer Affairs, of the units supplied to pharmacy offices or pharmacy services which radiate on national territory, as well as, where appropriate, other wholesale warehouses, irrespective of the Autonomous Community in which they radiate.

32. Failure To Communicate Pharmacy Offices information about dispensed medications referred to in this Act.

33. Cometer three violations rated as mild within one year.

c) Very severe infractions:

1. The placing on the market of medicinal products or medical devices of any nature without having obtained the prescriptive health authorization for this purpose.

2. Counterfeit Medication.

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 laid down in the legislation in force or the rules of good clinical practice, as well as the conduct of a clinical trial without adjusting to the protocol (a) approved when it is detrimental to the rights, safety and welfare of the subjects or affects the credibility of the data obtained.

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 or medical devices at home or through the Internet or other telematic or indirect means, contrary to the provisions of this Law.

12. Incompliance with distribution stores 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 with distribution stores 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. The manufacture, manufacture, import, export, distribution, marketing, prescription and supply of products, preparations, substances or combinations thereof, which are presented as medicinal products without being legally recognized as such.

15. The breach of the obligation to subscribe to insurance, guarantee or equivalent financial guarantee in the cases required by this Law.

16. To conduct promotion, information or advertising of unauthorised medicinal products or without complying with the conditions laid down in the authorization, in the provisions of this Law and 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 related 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. Commit Three Serious-rated infractions within two years.

Article 102. Penalties.

1. Infringements in the field of medicinal products shall be punishable by fine, in accordance with Article 101 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. The penalties for serious and very serious infringements will be published in the official journal once they become firm.

4. It is for the exercise of the power of sanctioning the General Administration of the State or the Autonomous Communities that hold the inspector's function, in accordance with the provisions of Article 98 of this Law.

5. In addition, in the case of very serious infringements, the Council of Ministers or the competent bodies of the Autonomous Communities to which the implementation of the legislation on pharmaceutical products corresponds, may 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.

Article 103. 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 104. 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 IX

From the cessation action

Article 105. Prior to the exercise of the cessation action.

1. When an advertising of medicinal products for human use, medical devices or products with alleged health properties is contrary to this Law, its development provisions or the General Law of Health, affecting the interests Consumers and users will be able to request their cessation:

(a) The National Institute of Consumption and the corresponding bodies or entities of the Autonomous Communities and of the competent local authorities in the field of consumer protection.

b) Consumer and user associations meeting the requirements set out in the General Law for the Defence of Consumers and Users, or, where appropriate, in the autonomous legislation on the defence of consumers consumers.

(c) Entities in other Member States of the European Union referred to in Article 106 of this Law.

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 106. 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 the General Law of Health 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 105, 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 105.

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 National Consumer Institute 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 General Law for the Defence of Consumers and Users, or, where appropriate, in the autonomous legislation on the defence of consumers consumers.

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 Communities.

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 X

Rates

Article 107. Creation, regulation and territorial scope.

1. The fee for the provision of services and the performance of activities of the General Administration of the State in the field of medicinal products is hereby established.

2. The tax paid in this title shall be governed by the provisions of this Law, in its absence, by Law 8/1989, of 13 April, of Public Fees and Prices and Regulatory Provisions of Development.

3. This fee shall apply throughout the national territory in accordance with the provisions of Article 112 of this Law, and without prejudice to the powers of the Autonomous Communities.

Article 108. Taxable fact.

It constitutes the taxable fact of the fee the provision or realization, by the competent organs of the General Administration of the State, of the services or activities referred to in Article 111 of this Law relating to legally recognised medicinal products, medical devices, cosmetic products and personal hygiene products, pharmaceutical laboratories and wholesale warehouses.

Article 109. Exemptions.

1. The provision of services or activities relating to the manufacture of "medicinal products without commercial interest" referred to in Article 2.3 of this Law 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) of this Law.

3. Services and activities relating to cell therapy and gene therapy medicinal products to be carried out by entities of a public nature integrated into the National Health System shall be exempt from the payment of the corresponding fee. such as those 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 will be reduced by ninety-five percent of the amount set 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.

Article 110. 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 111. Amount.

1. The amount of each euro fee shall be:

Taxable

8.4 Clinical Implant Health Record Procedure.

8.33 Extensions of CE marking certifications.

Amount - Euros
Group I. Industrial-crafted human use drugs and special drugs
1.1 Procedure authorization and enrollment in the registration of a generic human-use drug.	7,713.25
1.2 Authorization and Enrollment Procedure in the registration of an advertising human drug.	7.713, 25
	1.3 Authorization and enrollment procedures in the registry of a human-use drug other than those referred to in the headings 1.1 and 1.2.	18.962.06
1.4 Transmission procedure for entitlement to a human use drug.	644.31
1.5 Procedure modification of the authorisation of a medicinal product for human use, defined as being of "major importance" in Regulation (EC) No 1084/2003 of the European Commission of 3 June 2003 concerning the examination of amendments to the terms of the marketing authorisations for medicinal products for human use and veterinary medicinal products granted by the competent authority of a Member State.	6.513.43
1.6 Procedure for modifying the authorization of a medicinal product for human use, qualified as type 1.b) in Regulation (EC) No 1084/2003 of the European Commission of 3 June 2003 concerning the examination amendments to the terms of the marketing authorisations for medicinal products for human use and veterinary medicinal products granted by the competent authority of a Member State.	1.142, 43
	1.7 Procedure for modifying the authorization of a human-use drug, qualified as type 1.a) in Regulation (EC) No 1084/2003, of the European Commission of 3 June 2003 concerning the examination of the amendments to the terms of the authorisations of marketing of medicinal products for human use and veterinary medicinal products granted by the competent authority of a Member State.	662.50
1.8 Human Use Drug Authorization Refresh Procedure.	2.142.44
1.9 Presentation of simple annual declaration of intent to market an already authorized human use drug.	109.92
	1.10 Authorization procedure for "parallel import" of a human-use drug.	675.75
1.11 Authorization modification procedure for "parallel import" of a human use drug.	335.17
Renewal Procedure for Authorization for the "parallel import" of a human-use drug.	335.17
European Certificate of Batch Release for Vaccines and Human use blood products when the analysis of a bulk and a human drug is required.	675.75
Expedition European certificate of batch release for vaccines and blood products for human use when the analysis of a human-use medication.	335.17
Periodic Safety Report Assessment of a Drug	a) Weekly and yearly: 350. b) Triennial: 2120.
Group II. Medicinal plant
2.1 Simplified procedure of authorization of a traditional herbal medicinal product.	2.000.00
	2.2 Authorization and enrollment procedures in the registration of a herbal drug, except 2.1.	7.713, 25
	2.3 Transmission procedure for the entitlement of the authorization of a medicinal plant drug.	432.07
2.4 Procedure for modifying the conditions of authorization placing on the market a medicinal product, defined as being of "major importance" in Regulation (EC) No 1084/2003 of the European Commission of 3 June 2003.	1.142.43
2.5 Procedure for amending the conditions of authorisation placing on the market a medicinal product, defined as being of "minor importance" in Regulation (EC) No 1084/2003 of the European Commission of 3 June 2003.	510.00
	2.6 Procedure for amending the conditions of authorisation marketing a traditional herbal medicine, defined as "major importance".	510.00
2.7 Procedure modification of the conditions for the marketing authorisation of a traditional herbal medicinal product, defined as "minor importance".	310.00
2.8 Renewal procedure for authorization of a plant drug medicinal.	1.434.97
2.9 Presentation of a simple annual declaration of intent to market a medicinal plant medicine already authorized.	84.11
3.1 Authorization procedure and enrollment in the registration of a homeopathic medication.	7,713.25
3.2 Authorization procedure and enrollment in the registration of a homeopathic drug with no approved therapeutic indication.	562.22
3.3 Transmission of the Entitlement of the authorization of a homeopathic medication.	432.07
3.4 Procedure for modifying the authorization of a homeopathic medicine.	1.142.43
3.5 Procedure for renewing the authorization of a homeopathic medicine.	1.434, 97
3.6 Renewal Procedure for the authorization of a homeopathic drug without approved therapeutic indication.	281.11
3.7 Simple annual declaration of declaration intention to market an already authorized and enrolled homeopathic medicine.	84.11
Group IV. Medicinal gases
4.1 Authorization procedure and registration of a medicinal gas.	7.713.25
4.2 Transmission procedure for entitlement of medicinal gas authorization.	432.07
4.3 Procedure for modifying the authorization of a medicinal gas.	1.142, 43
	4.4 Renewal procedure for authorization of a medicinal gas.	1.434.97
4.5 Simple annual declaration of intent to market an already authorized medicinal gas.	84.11
Group V. Clinical Research
5.1 Authorization procedure for a clinical trial with an unauthorized human-use medication enrolled in Spain.	3.757.19
5.2 Clinical trial authorization procedure with authorized and enrolled human-use drugs in Spain.	102.71
5.3 Qualification procedure for a veterinary medicinal product not authorized in Spain.	129.74
5.4 Clinical trial authorization procedure with authorized and enrolled veterinary medicinal products in Spain.	102.71
Group VI. Pharmaceutical
6.1 Opening authorization procedure for a pharmaceutical laboratory.	4.577.15
6.2 Notice of change of ownership of a pharmaceutical or naming change laboratory, registered office or legal representative.	129.74
6.3 Lab Authorization Modification Procedure pharmacist.	4.577.15
6.4 Individual inspecting actuations at the request of a party, except in the case of a complaint or at the request of a representative user or consumer association.	4.577.15
6.5 Approved Drug Manufacturing Authorization Procedure in other countries and not registered in Spain.	161.53
Group VII. Certifications and reports
7.1 Expedition of a certification.	129.74
7.2 Assessment and scientific report on the quality, safety and efficacy of a medicinal product for human or veterinary use, at the request of the data subject, during the research and development stages of the product, or to initiate a recognition procedure mutual.	3.863.28
7.3 Other scientific advice not provided under item 7.2.	324.36
Group VIII. Sanitary, cosmetic, and hygiene
8.1 Cosmetic special declaration procedure.	446.20
8.2 Individual registration and authorization procedure for hygiene and disinfectant products.	446.20
8.3 Healthcare product registration and enrollment procedure.	446.20
736.90
8.5 Modification and validation procedure for hygiene products, disinfectants, and sanitary products.	155.49
8.6 Certificate Issue Procedure.	135.20
Prelicense procedure for the operation of cosmetic, toothpaste, and hygiene products and disinfectants: establishment	655.78
8.8 Pre-operating license procedure for cosmetic, dentifrice, and cosmetic products hygiene and disinfectants: import establishment.	338.04
	8.9 Procedure for modifying the previous operating license for cosmetic, toothpaste, and hygiene products and disinfectants regarding their placement: manufacturing facility.	655.78
8.10 License modification procedure prior to the operation of establishments of cosmetic, toothpaste and hygiene products; and disinfectants as regards their placement: import establishment.	338.04
8.11 License modification procedure operation of cosmetic, toothpaste and hygiene and disinfectant products.	155.49
8.12 confidentiality authorization of cosmetic ingredients.	446.20
	8.13 Healthcare products operating license procedure: manufacturing establishment, pool.	655.78
	8.14 Healthcare product operating license procedure: import establishment.	338.04
8.15 Modification Procedure of the prior operating license of sanitary products establishments as regards their placement: manufacturing facility, pool.	655.78
8.16 Procedure for modifying the prior operating license of sanitary products establishments as regards their location: import establishment.	338.04
8.17 Procedure for modifying the prior operating license of sanitary products establishments.	155.49
8.18 Procedure Revalidation of the license of sanitary products, cosmetics, disinfectants, and hygiene products: manufacturing facility.	473.24
8.19 Revalidation procedure for license of establishments sanitary products, cosmetics, disinfectants, and hygiene products: import establishment.	290.71
8.20 Authorization of clinical investigations.	263.66
8.21 Active Principle Assessment Report embedded in a healthcare product.	1.352, 12
8.22 Evaluation certification files for the "CE" marking of sanitary products belonging to the same family, by full quality assurance system.	4.635.75
	811.27
8.24 Assessment of the certification dossier for the CE marking of medical devices belonging to the same family, by means of the EC declaration of conformity combined with quality assurance of production, EC verification or quality assurance of the product.	676.07
8.25. Product and product batch verification.	210.50
8.26 Product CE marking certification dossier assessment health by design "CE" examination.	1.487.34
8.27 Initial audit according to full quality assurance system.	2.704.26
8.28 Initial Audit according to production quality assurance.	2.163.41
8.29 Initial audit according to product quality assurance.	1.352.12
8.30 Tracking and Extension Audits of the "CE" marking certification.	1,622.57
8.31 Supplemental and Repeat Local Audits.	649.03
8.32 Modification of administrative data in CE marking certification.	135.20
135.20
Group IX. Veterinary medicinal
9.1 Authorization procedure and registration of a veterinary medicinal product, essentially similar.	3.856, 62
9.2 Authorization procedure and enrollment in the registry of a veterinary medicinal product other than that referred to in item 9.1.	9.481.02
Procedure for the transmission of the entitlement of a veterinary medicinal product's authorization.	644.31
Procedure modification of the authorisation of a medicinal product for veterinary use, defined as being of "major importance" in Regulation (EC) No 1084/2003 of the European Commission of 3 June 2003 concerning the examination of amendments to the terms of the marketing authorisations for medicinal products for human use and veterinary medicinal products granted by the competent authority of a Member State.	3.256.72
Procedure for modifying the authorization of a veterinary medicinal product, qualified as type 1.b) in Regulation (EC) No 1084/2003 of the European Commission of 3 June 2003 concerning the examination of amendments to the terms of the marketing authorisations for medicinal products for human use and veterinary medicinal products granted by the competent authority of a Member State.	1.120.03
Procedure for modifying the authorization of a veterinary medicinal product, qualified as a type 1.a) in Regulation (EC) No 1084/2003 of the European Commission of 3 June 2003 concerning the examination of amendments to the terms of the marketing authorisations for medicinal products for human use and veterinary medicinal products granted by the competent authority of a Member State.	662.50
9.7 Veterinary use drug authorization renewal procedure.	2.142, 44
Presentation of a simple annual declaration of intent to market an already authorized veterinary medicinal product.	109.92
Authorisation and registration procedure in the registry of a veterinary medicinal product specifically intended for minor species.	2.332.15
9.10 Periodic report evaluation of a veterinary use drug.	a) Weekly and yearly: 350. b) Triennial: 2.120.00.
9.11 Authorization procedure for "parallel importation" of a veterinary medicinal product.	675.75
Group X. Financing procedures from public funds and pricing of healthcare
10.1 Procedure for the inclusion of a medical device in the pharmaceutical provision of the National System of Health.	337.71
Exclusion Procedure for a Healthcare Product in the Pharmaceutical Delivery of the National Health System.	337.71

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 veterinary medicinal products, the extension of an authorisation to the new target species shall be considered as an extension of the line.

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.

For the purposes of the rate described in paragraphs 8.1 and 8.22, 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, as provided for in Law 8/1989, of 13 April, of Fees and Public Prices, may be modified through the Law of General Budget of the State.

4. Where the assessment and control of a medicinal product or product requires action abroad or exceptional costs, the corresponding fees shall be settled on the actual cost of the service in which the taxable event consists.

The actual cost of the service shall also be settled on the costs of travel, subsistence and testing resulting from the actions provided for in the headings 8.21, 8.22, 8.23, 8.24, 8.25 and 10.1.

5. Where, in the authorisation and registration procedure in the register of a medicinal product for human or veterinary use, which correspond to the rates laid down in the headings 1.1, 1.2, 1.3, 1.5, 9.1 and 9.2, the application submitted is rejected in the Validation phase shall be carried out at the rate of 70 per cent of the total fee.

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 referred to in item 1.12.

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 1.12.

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.

Article 112. Accrual.

The fee shall be payable at the time the service is initiated or the performance of the administrative activity is initiated. Where the serious fee is issued, the application initiating the file shall be due at the time of submission.

Article 113. Payment.

1. The fee shall be paid in accordance with the provisions of Law 8/1989, of 13 April, of Public Fees and Prices, Law 58/2003 of 17 December, General Tax, and other implementing rules.

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 three months of the entry.

5. The management of the fees regulated in this Law is, on a voluntary basis, the Ministry of Health and Consumer Affairs and the Spanish Agency for Medicines and Health Products, according to their respective competence.

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 As required for health care, the Ministry of Health and Consumer Affairs, in addition to the tasks assigned to it by the Law, shall carry out the following tasks:

(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, personal hygiene and cosmetic products.

1. In accordance with the provisions of this Law, the conditions and requirements for the manufacture, import, clinical investigation, distribution, marketing, placing on the market, placing on the market, shall be determined. 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 preceding paragraph shall also apply, where appropriate, to personal hygiene and cosmetic products.

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 89 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 to be dispensed, through the official prescription of the National Health System, on a national territory, the quantities that are to be applied on their quarterly volume of sales through the said system must be entered on a four-monthly basis. recipe, the percentages referred to in the following scale:

Sales to PVL		Contribution
From
0	3.000,000.00	1.5%
3.000.000.01	Forward	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 in the framework of the PROFARMA action according to the percentages set out in the following table:

Not valued: 0.00.

Acceptable: 5%.

Good: 10%.

Very good: 15%.

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 business groups will communicate to the Ministry of Health and Consumer Affairs, during the month of January each calendar year, the companies integrated in 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 the companies constituting a unit of decision, in the terms of Article 4 of Law 24/1998 of 28 July, of the Securities Market, are considered to belong to the same group.

2. The Ministry of Health and Consumer Affairs, acting as provided for in the previous paragraph and on the sales of the year immediately preceding it, shall communicate the quantity to be entered for each manufacturer, importer or supplier concerned, as well as the time limit for entry of that quantity. In the first period of the following financial year, the appropriate liquidations shall be carried out.

3. The amounts to be entered will be allocated to research in the field of biomedicine in sufficient quantity to finance the needs of clinical research carried out through the sector's research initiative 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 health cohesion policies, training programmes for medical practitioners and pharmacists, as well as to health education programmes for the population in order to encourage the rational use of medicines, according to the distribution to be determined by the Ministry of Health and Consumer Affairs prior report of the Interterritorial Council of the National Health System, being admitted to the Public Treasury.

Additional provision seventh. Preservation of organs for transplants.

The solutions for the preservation of organs for transplantation will be governed, as soon as they are applicable, as provided for in this Law for medicinal products.

Additional disposition octave. Advertising medicines.

The price set on the packaging of the advertising medicines will 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 in decision-making procedures for medicinal products and medical devices.

The Autonomous Communities will participate, in the established terms, in the Rector Council of the Spanish Agency for Medicines and Health Products, as a collegiate body of management of the agency. The Agency will also have the collaboration of independent experts of recognised scientific prestige proposed by the Autonomous Communities.

The Ministry of Health and Consumer Affairs will provide a report to all Autonomous Communities at each meeting of the Interterritorial Council of the National Health System, identifying the name of the drugs and medical devices. which have been authorised by the Spanish Agency for Medicinal Products and Health Products since the last Council meeting, as well as the price of those medicinal products and medical devices which have been included in the financing of the System National of Health.

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 that the provisions of this Law are complied with, for the purposes 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. Review of medicinal products subject to prescription.

To facilitate the work of healthcare professionals who, in accordance with this Law, cannot prescribe medication, within one year the Ministry of Health and Consumer Affairs will establish the relationship of medications that may be used or, where appropriate, authorised for these professionals, as well as the specific conditions in which they may be used and the mechanisms for participation with doctors in monitoring programmes for certain treatments.

Additional disposition thirteenth.

The placing or putting into service of medical devices by an optional, in the exercise of their professional privileges, shall not be considered as dispensing, marketing, selling, distribution, supply or placing on the market of the same, for the purposes of Articles 3.1 and 101. In any case, the optional should separate its fees from the manufacturing costs.

First transient disposition. Application of the Law to applications for authorisation submitted before 1 November 2005.

The data exclusivity periods set out in Articles 18 and 34 shall not apply to the reference medicinal products for which an application for authorisation has been submitted before 1 November 2005.

The periods of data exclusivity for the reference medicinal products for which an application for authorisation has been submitted before 1 November 2005 shall be those which governed prior to the entry into force of this Regulation. Law.

Second transient disposition. Conflict of interest.

Without prejudice to compliance with the provisions of this Law, and in particular Article 3 thereof, pharmacists in professional practice with a pharmacy office or in a hospital pharmacy service and other structures care, that upon the entry into force of this Law have direct economic interests in authorized pharmaceutical laboratories, they will be able to maintain those interests until the extinction of the authorization or transfer of the laboratory.

Transitional provision third. Renewal of authorization of medicinal products.

Following the entry into force of this Law, the medicinal products must be renewed as soon as they are concerned. The provisions of the rules in force in relation to periodic safety reports shall apply to them from that renewal.

Transitional disposition fourth. Adaptation of authorizations to exercise distribution activities.

The holders of administrative authorizations in force for the entry into force of this Law will have to adapt to the requirements for the exercise of the distribution activities, for which they will have to present, in their case, the a request within three months of the entry into force of the application. After that period without having applied for adaptation, the corresponding titles shall be deemed to be revoked in full.

Transient disposition fifth. Indications in the braille alphabet.

The provisions of Article 15 (5) shall only be required for medicinal products placed on the market six months after the entry into force of this Law.

Transitional disposition sixth. Gallic innovations.

Gallic innovations or innovative pharmaceutical forms which, at the entry into force of this Law, have been excluded for seven years from the reference price system in accordance with the third paragraph of Article 94.6 of the Law 25/1990, of 20 December, will be incorporated into it. In the case of innovative forms which have been excluded from the system for a period of less than seven years, the exclusion provided for in Article 93.2 shall apply to them for years which are excluded from the system: six years excluding one, five excluding two, four excluding three, three years excluding four, two years excluding five and one year for which six are excluded.

Transitional disposition seventh. Contributions to the National Health System.

The forecasts contained in the additional sixth provision will only apply from the four months immediately following the entry into force of this Law, and until then, for the purposes of settlements, as provided for in the ninth provision of Law 25/1990 of 20 December 1990.

Transient disposition octave. Application of the pricing system in the health products authorized prior to the validity of the Law.

The medical devices authorized prior to the entry into force of this Law will have a maximum industrial price resulting from the application of the price system regulated in this Law, starting from the current PVP and discounting the Marketing margins.

Transient disposition ninth.

Drug license holders will have a period of six months, from the date of publication of this Law in the Official State Gazette, for compliance with the provisions of the last two paragraphs of the Article 15 (5) of this Law.

Single repeal provision. Regulatory repeal.

The provisions of this Law and, in particular, Law 25/1990 of 20 December of the Medication are repealed.

Final disposition first. Legislation on pharmaceutical products and basic regulation.

This Law is issued under the following State jurisdiction titles:

1. Titles I, II, except Article 38, third, fourth, except Chapter II, V, Articles 75.2, 76, 78, 79, 80, 82, 85, 86, 87, 90, 91, 92, 93, 98 and 99 of Title VII and VIII, the first, second and seventh provisions, and the transitional provisions, have the status of legislation on pharmaceutical products and are dictated under the terms of Article 149.1.16. of the Constitution.

2. Articles 38, 68 to 71, 75.1, 3, 4 and 5, 77, 81, 83, 84, 95, 96 and 97 and the third and fourth additional provisions have the status of basic rules and are dictated by Article 149.1.1. and 16. of the Constitution, which it attributes to the Exclusive competence in the field of bases and general coordination of health.

3. Articles 88, 89 and 94, 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 social security.

4. Title IX is issued under Article 149.1.6. of the Constitution, which gives the State exclusive jurisdiction in matters of procedural law.

5. Title X is issued under Article 149.1.14. of the Constitution, which gives the State exclusive competence in matters of the General Finance.

6. The second final provision is made under Article 149.1.9. of the Constitution, which gives the State exclusive competence in matters of industrial property.

Final disposition second. Amendment of the Patent Law.

Article 52.1 of Law 11/1986, of 20 March, of Patents, by the following wording of paragraph 1 (b), is amended:

" (b) to acts carried out for experimental purposes relating to the subject matter of the patented invention, in particular studies and tests carried out for the authorisation of generic medicinal products, in Spain or outside Spain; and the following practical requirements, including the preparation, procurement and use of the active substance for these purposes. '

Final disposition third. Amendment of Law 8/2003 of 24 April on Animal Health.

Article 63 of Law 8/2003 of 24 April of Animal Health is amended, which will have the following wording:

" In the case of biological products, where necessary in the interest of animal health, the Ministry of Agriculture, Fisheries and Food may submit to official control the batches of products before they are placed on the market, the terms that are determined to be determined. "

Final disposition fourth. Health Technology Assessment Agency.

New wording is given to Article 21 (2) of Law 16/2003, of 28 May, of cohesion and quality of the National Health System, in the following terms:

" The new techniques, technologies or procedures will be evaluated, prior to their use in the National Health System, by the Ministry of Health and Consumer Affairs, through the Agency of Evaluation of Health Technologies of the Carlos III Health Institute, which will be carried out in collaboration with other evaluators proposed by the Autonomous Communities, in the terms provided for in regulation. "

Final disposition fifth. Regulatory development.

The Government is authorised, in the field of its powers, to approve regulations and standards for the implementation and development of this Law.

Final disposition sixth. Entry into force.

This Law shall enter into force on the day following that of its publication in the "Official Gazette of the State".

Therefore,

I command all Spaniards, individuals and authorities, to keep and keep this law.

Palma de Mallorca, 26 July 2006.

JOHN CARLOS R.

The President of the Government,

JOSE LUIS RODRIGUEZ ZAPATERO