Law 10/2013 of 24 July, incorporating into Spanish law the Directives 2010 /84/EU of the European Parliament and of the Council of 15 December 2010 on pharmacovigilance, and 2011 /62/EU of the European Parliament European and Council of 8 June 2011 on the prevention of the entry of counterfeit medicinal products into the legal supply chain, and amending Law 29/2006 of 26 July on the guarantees and rational use of medicinal products and products health, has led to the incorporation of certain aspects of relevance in the field of delivery (i) pharmaceutical products in the National Health System, and particularly with regard to the reference price system, the requirement for a generic or biosimilar medicinal product to be used for the formation of reference assemblies as soon as the legislation It only referred to the requirement for a generic medicinal product to exist, which was an unjustified limitation in the process of forming reference assemblies.

The Spanish National Health System continues to maintain the principle of universality of health benefits, although the need for mandatory efficiency in all orders of public activity requires profiling and shaping a pharmaceutical delivery consistent with the social and health characteristics of the population and the state of the biomedical knowledge of each moment. These premises require systems to support governmental and regulatory decisions on the incorporation and updating of new presentations of medicinal products to the pharmaceutical delivery of the National Health System, as well as boosting economies within the System, especially when the innovation has become a regular therapeutic tool and, having extended its use, there have been sufficient returns for the incumbent companies.

The reference price systems for medicinal products financed by the national health systems are in force in many Member States of the European Union. In the case of Spain, its application dates back to the end of the 20th century and has been demonstrated as a basic tool for the introduction and promotion of competitiveness within the pharmaceutical sector.

On the other hand, the reference price system for medicinal products requires, by its very nature, regular updates in order to incorporate into it the changes in structure and prices which, on a continuous basis, are are registered on the market. The expiry of patents and periods of protection, as well as the entry into the system of financing of the National Health System of new bidders, obliges its periodic update which, in the case of the Spanish system, must be annual.

The legal changes mentioned and the evolution of the pharmaceutical consumption pattern force changes in the procedures applied in the updates of the Spanish reference price system. The presence of biosimilar medicinal products makes it necessary to adapt regulation and operating procedures, placing them on an equal footing with generic medicines. On the other hand, the implementation of therapies with biological treatments and others which, for regulatory reasons, have privileged situations in the market without competition in prices, beyond the periods provided for in the legislation For the recognition of innovation, there is sufficient reason to introduce rationalisation and savings mechanisms so that they do not constitute an unassuming charge for the National Health System. Hence the need to extend the reference price system to medicines that have been in such situations for more than ten years and for which the return or reward for innovative effort has been sufficiently covered.

At the same time, it is necessary to establish forecasts aimed at ensuring the necessary supply of medicinal products and to prevent the reference price system from exerting perverse effects by causing the Pharmaceutical delivery of the National Health System of drugs with decades of experience in the care practice and that have brought great efficiency to the biomedical work. The purely mathematical mechanisms of any reference price system, applied to the generality of medicinal products, should moderate their application by means of exceptional corrective measures, so that decisions to exclude the Classic and highly efficient medicines.

This royal decree also regulates homogeneous groupings, which constitute a mechanism for extending the principles of the reference price system and allow for the early incorporation of price improvements financing in those presentations of medicinal products whose marketing authorisation holders have decided to reduce the price for the purpose of improving their market penetration. This tool has been incorporated into the practice of pharmaceutical delivery very quickly and is allowing significant savings in the pharmaceutical bill.

Royal Decree-Law 16/2012 of 20 April, of urgent measures to ensure the sustainability of the National Health System and improve the quality and safety of its benefits, and Law 10/2013, of 24 July, have amended the Law 29/2006 of 26 July, differentiating the concept of lower prices and lower prices for homogeneous drug groupings, and establishing that the lower prices of the new homogeneous groupings will be automatically fixed in the Nomenclator, and that its update will be made on a quarterly basis.

This system of homogeneous groupings allows the application of the assumptions of supply and substitutions provided for in Articles 85 and 86 of Law 29/2006 of 26 July. In the prescription for active substance, the pharmacist dispenses the lowest price medicine of its homogeneous group and, in the case of equality, the generic medicine. The prescription for commercial designation of medicines is possible as long as the principle of greater efficiency is respected for the system. However, if the prescribed medicinal product has a higher price than the lower price of its homogeneous group, the pharmacist must replace it with the lowest price medicinal product in its homogeneous group and, in the case of equality, dispense the medicinal product generic.

By means of this royal decree, it is necessary, for the first time, to its regulatory development. The regulated system determines a lower price for each homogeneous group of medicines that corresponds to the price of the lowest price drug presentation at the time of their training.

The lower prices of the homogeneous drug groupings correspond to the price of the lowest price presentation at the time of the creation of the corresponding homogeneous group. The lower prices are updated every three months. The revised lower price of each homogeneous pool will correspond to the price of the lowest price presentation at the time of each quarterly update. Thus, in the month in which the update occurs, the lower prices match the lower prices. But during the next two months, until they are updated, the laboratories can request a voluntary reduction in price, and in these cases the price is below the lower price, becoming the lowest price of the homogeneous group. until the next minor price update.

Therefore, the reference price systems and homogeneous group of drug presentations are complementary. The reference price system is based on the fixing of the maximum price to which each presentation of the medicinal product is financed, with an annual review system which may result in a compulsory price reduction. Unlike the reference prices, the system of homogeneous groupings is related to the rules of prescription and dispensation. The system determines the lowest price and lowest price for the presentations of integrated medicines in each homogeneous grouping, with voluntary price reductions that encourage the competition regime between the different laboratories. marketing of medicinal products integrated into the system of homogeneous groupings. This system requires greater agility, and thus its immediate application, with quarterly updates.

Finally, the royal decree comes to regulate the information systems used in the pharmaceutical provision of the National Health System without which the application of the reference and grouping price systems Homogeneous would not be possible. Spain has a long tradition in the creation, use and adaptation of these systems, and in particular the official Nomenclator of the pharmaceutical supply of the National Health System. legal.

This royal decree is issued under the fifth additional provision of Law 29/2006 of 26 July, which authorizes the Government, in the field of its powers, to approve the regulations and rules for the application and Article 93 (1) of the Constitution provides for the development of Article 93 and the additional provision of the fourteenth and in accordance with the provisions of Article 149.1.16 of the Constitution which confers exclusive competence on the State on the basis of Article 93 (1) of the Treaty. legislation on pharmaceutical products.

According to the provisions of Articles 67.2 and 71 of Law 16/2003, of 28 May, of cohesion and quality of the National Health System, it has been the subject of prior report by the Advisory Committee and the Council Plenary Session. Interterritorial of the National Health System, as well as the Spanish Data Protection Agency, pursuant to the provisions of the Organic Law 15/1999, of 13 December, of Protection of Personal Data and in the Statute of the aforementioned Agency, approved by Royal Decree 428/1993, of March 26.

Likewise, in accordance with Article 3.1.a) of Royal Decree 434/2004 of 14 March, establishing the Inter-Ministerial Commission for the Study of Matters with Budgetary Transcendence for Financial Balance of the National Health System or significant economic implications, the mandatory report of the aforementioned Inter-Ministerial Commission has been gathered.

In the process of elaboration, among others, the autonomous communities and cities of Ceuta and Melilla have been consulted and the sectors affected have been heard.

In its virtue, on the proposal of the Minister of Health, Social Services and Equality, in agreement with the Council of State, and after deliberation by the Council of Ministers at its meeting on 21 March 2014,

DISPONGO:

CHAPTER I

General character provisions

Article 1. Object and scope of application.

This royal decree is intended to regulate:

(a) The reference price system for medicinal products, for the use of medicinal products included in the pharmaceutical provision of the National Health System.

(b) The system of homogeneous groups of medicinal products, for the use of medicinal products included in the pharmaceutical provision of the National Health System, which can be dispensed by a prescription or official supply order in pharmacy office.

c) Certain information systems for the financing and pricing of medicines and medical devices in the National Health System.

CHAPTER II

Drug Reference Pricing System

Article 2. Financing the presentations of medicinal products submitted to the reference price system.

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

2. The reference price system is intended to set the reference price or maximum level to be used for the financing of the presentations of medicinal products included in reference sets to be determined in accordance with the provisions of the Article 3, provided that public funds are prescribed and dispensed by means of the fixing of an industrial reference price or reference laboratory selling price (PVLRef) for each presentation of a medicinal product, which shall be of a maximum.

The reference industrial price, calculated in accordance with Article 4, shall be added, where appropriate, to the margins corresponding to the wholesale distribution and distribution activities to the public, as well as to the taxes to determine the maximum amount of funding for the presentations of medicinal products.

Article 3. Drug reference sets.

1. The drug reference set is the basic unit of the reference price system and will consist of two or more drug presentations. Each medicinal product reference set shall include all presentations of medicinal products included in the pharmaceutical provision of the National Health System having the same active substance and the same route of administration.

2. For each reference set there shall be at least one generic or biosimilar medicinal product. However, in the absence of a generic or biosimilar presentation of a medicinal product, it shall also be formed as long as the medicinal product or its main active ingredient has been authorised at least ten years in advance in Spain or in any other Member State of the European Union, and in addition there is a medicinal product other than the original and its licences.

3. Independent reference sets shall be constituted in the following assumptions:

(a) Presentations of medicinal products in a hospital setting, with the understanding of the presentations, in normal packaging, of qualified medicinal products for hospital use and medicines without the qualification of hospital use have established unique reserves in the field of the National Health System consisting in limiting their dispensation to non-hospitalized patients in the pharmacy services of hospitals.

b) Prescription of medicinal products in clinical packaging.

c) Drug presentations indicated for pediatric treatments.

4. For the formation of reference sets, only the presentations of medicinal products shall be taken into account from the date of effectiveness of their inclusion in the pharmaceutical provision of the National Health System, as established in the Additional provision sixth. The presentations of medicinal products in the cases of suspension, revocation or cessation of their placing on the market as provided for in Articles 69 and 70 of Royal Decree 1345/2007 of 11 October 2007 shall not be taken into consideration. the procedure for the authorisation, registration and conditions for the supply of medicinal products for human use produced industrially, on the basis of the registration of this situation in the official Nomenclature of the pharmaceutical supply of the National System of Health, in accordance with the provisions of Article 12.

5. The reference sets of medicinal products shall be deleted only if they no longer comply with the training requirements laid down in the preceding paragraphs. The presentations of drugs belonging to reference sets that are suppressed, but which remain included in the pharmaceutical provision of the National Health System, will continue to maintain as the maximum industrial price the price The reference industry (PVL Ref) which was fixed at the time of the deletion of the whole, pending, where appropriate, a review of the whole of the package in accordance with the provisions of Article 91 of Law 29/2006 of 26 July of guarantees and use rational use of medicinal products and medical devices.

Article 4. Fixing the reference prices.

1. The reference price for each reference set of medicinal products shall be calculated on the basis of the cost/treatment/day (CTD) of the presentations of medicinal products in the integrated medicinal product, which will make it possible to determine the lowest cost/treatment/day will be the reference price of the set.

For these purposes, the cost/treatment/day of each drug presentation will be the result of dividing the industrial price to which it was being marketed (PVL com) between the number of defined daily doses (DDD) contains, according to the following formula:

CTD = PVL com/n. DDD of presentation

The defined daily doses will be officially assigned by the Collaborating Center of the World Health Organization in Statistical Methodology of the Medicines or, failing that, the calculated ex officio by the organ competent in the field of public financing and the fixing of the price of medicinal products and medical devices of the Ministry of Health, Social Services and Equality, in accordance with the methodology used by the said Centre.

2. The reference industrial price for each of the presentations of medicinal products integrated into a reference set shall be the result of multiplying the lower cost/treatment/day of the presentations in the grouped or reference price of the set (PRC), by the number of DDD contained in each presentation, according to the following formula:

PVLRef = PRC × n. º DDD of the presentation

3. In cases where the industrial reference price for a presentation of a medicinal product, determined in accordance with the general rule of calculation laid down in paragraph 2, is less than EUR 1,60, that quantity shall be fixed as an industrial price. Reference for that presentation.

However, where the industrial price to which a medicinal product is marketed is lower than the reference industrial price corresponding to it in application of this criterion, it shall be fixed as a price. industrial reference the industrial price to which it was being marketed.

4. For presentations of medicinal products with special doses of active substance, of use in serious diseases or whose prices have been revised for lack of profitability by the Interministerial Commission for the Prices of Medicinal Products in the two years immediately preceding the first day of the month of April in which the processing of the relevant order for which the annual update of the reference price system is to be initiated, and which by application of the general system the reference price calculation specified in paragraph 2 corresponds to a price (a) an industrial undertaking which does not guarantee its economic viability, a weighted reference industrial price (PVLRP), calculated on the basis of the cost/treatment/day (CTD) and on the basis of the aggregated invoicing data, shall be established on an exceptional basis. National Health System of the last 12 months available at the time of initiating the processing of the relevant order by which the annual update of the reference price system is carried out, according to the following formula:

PVLRP = [CTD (CTD × n. number of containers billed for each presentation) × n. º DDD of the presentation]/n. of total billed containers of the set

However, where the industrial price at which a medicinal product is marketed is lower than the weighted reference industrial price, it shall be set as the weighted reference industrial price of that product. presentation of the industrial price to which it was being marketed.

Article 5. Application of the reference price system.

1. On an annual basis and after agreement of the Government Delegation for Economic Affairs, the person holding the Ministry of Health, Social Services and Equality, by means of the corresponding order, shall update the system of reference by the establishment of the new reference sets and the reference prices of the presentations of medicinal products included therein, the review of the reference prices for medicinal product presentations included in the existing sets and, where appropriate, the deletion of the sets when they leave comply with the requirements laid down in Article 3. To this end, the processing of the said annual update order shall be initiated, each year, in the month of April and the information of the official Nomenclator of the pharmaceutical supply of the National Health System of application on day 1 of the the month of April in which the processing of the corresponding order is initiated.

2. The reference price system shall apply to new presentations of medicinal products which are included in the pharmaceutical provision of the National Health System if, for its characteristics, they can be integrated into one of the reference sets of medicinal products established by the relevant order in respect of the annual update of the reference price system. To this end, the decisions of the person who is the head of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality for which new presentations of medicinal products in the pharmaceutical supply of the National Health System, shall collect the express declaration of integration of the same in any of the reference sets of existing medicinal products if by their characteristics they can be included in the same.

3. The reference price system shall also apply to the presentations of medicinal products which are included in the pharmaceutical provision of the National Health System prior to the date of application of the relevant order by the the annual update of the reference price system, but the effectiveness of the inclusion in the pharmaceutical supply of the reference price system is made after the start of the procedure for the preparation of the relevant order. To this end, the head of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality will automatically integrate these presentations of medicinal products into one of the of the existing assemblies, if by their characteristics they can be included in the same, with the following deadlines for the application of the new reference prices which correspond:

(a) If the effectiveness of its inclusion in the pharmaceutical provision of the National Health System in accordance with the provisions of the fifth additional provision, occurs prior to the date of application of the corresponding the order in which the reference price system is to be updated annually, the time limits for the application of the reference prices shall be those laid down in that order.

(b) If the effectiveness of its inclusion in the pharmaceutical provision of the National Health System in accordance with the provisions of the additional sixth provision occurs after the date of application of the corresponding provision the order in which the reference price system is to be updated annually, the reference prices shall be applicable at the time when the effectiveness of their inclusion in the pharmaceutical supply is produced.

Article 6. Time limits for the application of the new reference prices.

1. Presentations of medicinal products with an industrial price higher than the reference price shall be supplied by the relevant marketing authorisation holder or, where appropriate, the local representative in Spain responsible for the marketing authorisation. the offer to the National Health System at the industrial reference price from the date of application of the relevant order for the annual update of the reference price system.

Stocks of drug presentations affected by price reductions will continue to be marketed by the distribution entities at the dealer's selling price prior to this reduction for a period of time. 20 calendar days following the date of application of the relevant order in respect of the annual update of the reference price system.

Stocks of drug presentations affected by price reductions will continue to be marketed by the pharmacy offices at the retail price prior to this reduction until the last day of the first the month following the date of application of the relevant order in respect of the annual update of the reference price system.

2. The distribution entities and the pharmacy offices may return the corresponding marketing authorisation holder or, where appropriate, the local representative in Spain responsible for the offer to the National Health System, without charge. In addition, from the day following the end of the periods referred to in the preceding paragraphs, the stocks of medicinal product presentations with a price in the packaging prior to the reductions laid down in the corresponding order in respect of which the annual update of the reference price system is to be made.

3. For the billing of official prescriptions to the National Health System, including the special regimes of the General Mutuality of Civil Servants of the State (MUFACE), of the Social Institute of the Armed Forces (ISFAS) and of the General Mutuality Judicial (MUGEJU), the price before which the presentations of medicinal products are marketed shall be maintained until the last day of the first month following the date of application of the relevant order for which the Annual update of the reference price system. The new prices shall be settled with the new charges to the National Health System, including those for the mutual funds of officials mentioned above, closed from the first day of the second month following the date of application of the relevant order in respect of the annual update of the reference price system. To this end, the new reference prices shall be incorporated into the official Nomenclature of the pharmaceutical supply of the National Health System applicable on the first day of the second month following the date of application of the relevant order where the annual update of the reference price system is to be carried out.

4. Pursuant to Article 10 of Royal Decree-Law No 8/2010 of 20 May 2010 laying down extraordinary measures for the reduction of the public deficit, where the new reference prices are applicable, the Commission's presentation of the Medicinal products included in the reference price system shall be exempt from the application of the deductions provided for in Articles 8 and 9 of Royal Decree-Law 8/2010 of 20 May.

CHAPTER III

Homogeneous drug pool system

Article 7. System of homogeneous drug groupings.

1. The system of homogeneous groups of medicinal products allows the application of the cases of supply and substitution provided for in Articles 85 and 86 of Law 29/2006 of 26 July.

2. The system of homogeneous drug groupings requires the integration of drug presentations, included in the pharmaceutical provision of the National Health System that can be dispensed by prescription or dispensing order. Officers at the office of pharmacy, in a homogeneous group, provided that they meet the requirements laid down in Article 8. It also determines the lowest price and lowest price of the integrated drug presentations in each homogeneous pool.

3. It is for the holder of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality to establish, on its own initiative, the homogeneous groups of medicines and determine the presentations of medicinal products to be integrated in each of them when they meet the requirements set out in Article 8 (1), (2) and (3), as well as to fix and revise, ex officio, the lowest prices and lowest prices for each a uniform grouping as laid down in Article 8 (4), (5) and (6

.

4. Information on homogeneous drug groupings, their lower prices and lower prices shall be updated with the variations produced up to and including the 20th day of the immediate month preceding that of their application, and shall be published monthly, no more than the 25th of the immediate month prior to its application on the website of the Ministry of Health, Social Services and Equality. This information shall be entered in the official Nomenclator of the pharmaceutical provision of the National Health System of the month concerned, taking into account the rules for updating it laid down in Article 12.

Article 8. Homogeneous groups of medicines, fixing and revision of lower prices and lower prices.

1. In each homogeneous group of medicinal products, the presentations of the medicinal products financed with the active substance/s in terms of dose, content, pharmaceutical form or pharmaceutical form, and via the administration, which may be subject to exchange in your dispensation.

Homogeneous drug clusters will be differentiated exclusively from a drug and its licenses with the same industrial price.

2. For their integration into homogeneous groupings only the presentations of medicinal products will be taken into account from the date of effectiveness of their inclusion in the pharmaceutical delivery of the National Health System, as established in the Additional provision sixth.

No consideration will be given to the presentations of medicinal products in the cases of suspension, revocation or cessation of their marketing as provided for in Articles 69 and 70 of Royal Decree 1345/2007 of 11 October 2007. regulating the procedure for the authorisation, registration and conditions for the supply of medicinal products for human use produced industrially, on the basis of the registration of this situation in the official Nomenclature of the pharmaceutical National Health System, in accordance with the provisions of Article 12.

3. The formation of new homogeneous drug groupings will be noted in the official Nominator of the pharmaceutical supply of the corresponding National Health System of the month, taking into account the rules for its update established in the Article 12.

4. A lower price shall be fixed for each homogeneous group of medicinal products which shall correspond to the price of the lowest price medicinal product at the time of its formation, and shall be automatically fixed in the official Nomenclature of the pharmaceutical supply of the National Health System of the month concerned, taking into account the rules for updating it laid down in Article 12.

5. The lowest price for each homogeneous group of medicinal products will correspond to the price of the lowest price drug presentation in the official Nomenclator of the pharmaceutical delivery of the National Health System of the month. corresponding to the rules for their updating as set out in Article 12.

6. The lower prices of homogeneous drug groupings will be reviewed on a quarterly basis within the calendar year. The new revised lower price for each homogeneous pool will correspond to the lowest price presentation price at the time of each quarterly update, and will be automatically set in the official Payroll National Health System pharmaceutical for the months of January, April, July and October, taking into account the rules for their updating as set out in Article 12.

Article 9. Voluntary lowering of prices without change of national code for the presentations of medicinal products integrated into homogeneous drug clusters.

1. The marketing authorisation holder or, where appropriate, the local representative in Spain responsible for the offer to the National Health System of each of the presentations of medicinal products integrated into homogeneous groupings, may present to the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality, application for voluntary reduction of its industrial price without change of national code.

Applications for voluntary drop in industrial prices, for the purposes of lower prices, will only be taken into account if they account for at least a 10% reduction in the maximum industrial price in force for financing with public funds.

2. After the 4th day of each month, it shall be published on the website of the Ministry of Health, Social Services and Equal Information of the accepted applications for voluntary reduction of prices, presented from day 5 of the previous month to the day 4 inclusive of the corresponding month, which shall be automatically recorded in the official Nomenclator of the pharmaceutical provision of the National Health System of the following month.

3. Once this information has been published, a period of 3 working days will be given for the holders of the marketing authorisation or, where appropriate, local representatives in Spain responsible for the offer to the National Health System to request the voluntary drop in the industrial price of their drug presentations to match their price at the lowest price of the corresponding homogeneous pool.

4. Within the first 10 working days of each month it will be published on the website of the Ministry of Health, Social Services and Equality, the information of the voluntary low prices without change of accepted national code that will be registered automatically in the official Nomenclator of the pharmaceutical provision of the National Health System of the following month.

5. On the basis of the monthly publication on the website of the Ministry of Health, Social Services and Equal Information on the voluntary lower prices accepted as referred to in paragraphs 2 and 4 above, the following shall be published: the marketing authorisation or, where appropriate, local representatives in Spain responsible for the offer to the National Health System shall supply the new price for the presentations of medicinal products for which their application for a Voluntary reduction of industrial price. Distribution entities shall distribute to the new marketing price from the 20th of that month, and the pharmacy offices shall dispense with the new marketing price from day 1 of the following month.

6. The billing price for each drug presentation to the National Health System, including the special regimes of the General Mutual Society of Civil Servants of the State (MUFACE), of the Social Institute of the Armed Forces (ISFAS) and of The General Judicial Mutuality (MUGEJU), shall be the marketing price shown in the corresponding official Nomenclator of the pharmaceutical provision of the National Health System of each month.

CHAPTER IV

Information systems for the financing and pricing of medicines and medical devices

Section 1. The official nomenclator of the pharmaceutical delivery of the National Health System

Article 10. Concept, nature and purpose.

1. The official Nomenclator for the pharmaceutical provision of the National Health System is the Database of the Ministry of Health, Social Services and Equality in the field of pharmaceutical provision in the National Health System.

2. For the purposes of public financing of medicinal products and medical devices, and without prejudice to the provisions of Article 17.6 of Royal Decree 1718/2010 of 17 December 2010 on medical prescription and dispensing orders, the information collected in the Official nomenclator of the pharmaceutical supply of the National Health System prepared by the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality, shall prevail over any other source of information, whether public or private.

3. The dispensing and billing of medical prescriptions and orders for the supply of medicinal products and medical devices registered in the official Nomenclator of the pharmaceutical supply of the National Health System shall be carried out according to the conditions and prices collected in the same, corresponding to the month of billing, not being valid otherwise.

Article 11. Information to be collected in the National Health System's official Nomenclator of the National Health System.

1. The official Nomenclator of the pharmaceutical supply of the National Health System shall include:

(a) All presentations of medicinal products authorised to be placed on the market in Spain.

b) All medical devices included in the pharmaceutical provision of the National Health System for non-hospitalized patients dispensed by pharmacy office through prescription or dispensing order officers.

2. The following information shall be collected, where appropriate, for each medicinal product presentation recorded in the official National Health System pharmaceutical delivery system:

a) The essential characteristics that uniquely identify it.

b) The situation in the offer of the National Health System.

c) The effective date of marketing, suspension of marketing and revocation of the authorization.

d) Your maximum financing price, marketing price, and notified price.

e) The reference set to which it belongs and the reference price for the presentation.

f) The homogeneous grouping to which it belongs, lowest price, and lowest price of the homogeneous pool.

g) Deductions that are applicable in accordance with Articles 8, 9 and 10 of Royal Decree-Law 8/2010 of 20 May.

(h) The holder of the marketing authorisation or, where appropriate, the local representative in Spain responsible for the offer to the National Health System.

i) The singular reserves to the conditions of prescription and dispensation in the field of the National Health System.

(j) The indications financed in the event that only some of their therapeutic indications are financed.

k) Special conditions of prescription or dispensation in the field of the National Health System.

l) The appropriate input type.

3. The following information shall be collected for each health product registered in the official Nomenclature of the pharmaceutical supply of the National Health System:

a) The essential characteristics that uniquely identify it.

b) Your financing price and the reported price.

c) The reference set to which it belongs and the product reference price.

d) The homogeneous grouping to which it belongs, lowest price, and lowest price of the homogeneous pool.

e) The situation in the offer of the National Health System.

f) The company responsible for the offer to the National Health System.

g) The singular reserves to the conditions of prescription and dispensation in the field of the National Health System.

h) Special conditions of prescription or dispensation in the field of the National Health System.

i) The type of contribution that corresponds.

4. It is for the holder of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality, the determination of the concrete structure and content of the information to be collected in the official Nomenclator of the pharmaceutical provision of the National Health System as set out in the previous paragraphs. However, the health administrations of the autonomous communities, within the framework of the Standing Committee of Pharmacy of the Interterritorial Council of the National Health System, may propose any modifications of the specific structure and The content of the information is in better management of the pharmaceutical delivery.

Article 12. Update of the National Health System's official Nomenclator for pharmaceutical delivery.

The official Nomenclator of the pharmaceutical supply of the National Health System will be updated monthly and must include in the corresponding to each calendar month the variations on the previous one produced until the day 20 including the previous immediate month, being considered closed at that date, without prejudice to the provisions of the fifth additional provision.

Article 13. Communication, availability and access to the National Health System's official Nomenclator.

1. The official Nomenclator of the pharmaceutical supply of the National Health System will be available through electronic procedures, and accessible to all the Public Administrations involved in the management of the pharmaceutical provision of the National Health System, as well as for the General Council of Pharmaceutical Officers.

2. The communication of the availability of the Nominator of the National Health System applicable from day 1 of each calendar month shall be produced, with the exception of causes of force majeure, at the latest on the 25th of the immediate month preceding the one corresponding to or, in its case, the next business day.

3. By order of the person holding the Ministry of Health, Social Services and Equality, the conditions and access to this information by entities and other bodies, companies and individuals may be regulated.

Section 2. System of information support for pricing management and financing decisions for medicines and healthcare products

Article 14. Information system supporting the management of pricing and financing decisions for medicines and medical devices.

1. The Ministry of Health, Services and Equality shall have a computerised system for the management of the procedures laid down in Articles 89 to 92 of Law 29/2006 of 26 July in the field of public financing and the fixing of the prices of medicinal products and medical devices, which may be accessed through electronic procedures by the members of the Interministerial Committee for the Prices of Medicinal Products.

2. By order of the person holding the Ministry of Health, Social Services and Equality, access to that computerised system may be regulated by the marketing authorisation holder or, where appropriate, the local representative in Spain responsible for the offer to the National Health System, or the company responsible for the offer to the National Health System, for information regarding procedures affecting their respective medicines and medical devices.

Section 3. Information System on Drug Use in the National Health System Hospital Public Network

Article 15. Information system on the consumption of drugs in the hospital public network of the National Health System.

1. All the public administrations responsible for the management of the pharmaceutical supply of the National Health System, must send to the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality, on a monthly basis, and for a period not exceeding three months immediately preceding the date on which it is provided, information on the number of units or packages of medicines identified through their national code, consumed in the public network of centres Hospital of the National Health System. They shall also communicate the units corresponding to the foreign medicines consumed, identifying them by means of a univocal code that will be established by the Spanish Agency for Medicines and Health Products. The technological process shall be established in a manner determined by the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality.

2. For the purposes set out in the previous paragraph, the Ministry of Health, Social Services and Equality shall have a computerised system to enable knowledge of the evolution of the consumption of medicinal products in the public network of hospital National Health System, and whose information on the whole of the National Health System may have access, through electronic procedures, to the public administrations responsible for the management of the pharmaceutical supply of the System National of Health.

Additional disposition first. Obligation of communication to the Ministry of Health, Social Services and Equality of the marketing of a medicinal product licensed by an innovator.

1. For the purpose of properly identifying the medicinal products and their licences as referred to in Articles 3.2 and 8.1 of this royal decree, the marketing authorisation holder or, where appropriate, local representative in Spain responsible for the offer to the National Health System of presentations of medicines that are licensed, they must communicate and credit this situation to the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality, prior to the decision of its inclusion in the pharmaceutical provision of the National Health System. As long as this communication does not take place, the presentation of the medicinal product concerned may not be regarded as a licence from another with the corresponding effects which may be derived from reference prices and groupings. homogeneous.

2. In the case of presentations of medicinal products that are licensed, included in the pharmaceutical provision of the National Health System prior to the entry into force of this royal decree, they will be obliged to communicate and credit the General of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality, such situation within one month from the day of entry into force of this royal decree. In the absence of a communication within the prescribed period, the medicinal product concerned may not be regarded as the licence of another in the first order for the reference price system to be updated after the entry into force of this Regulation. decree.

Additional provision second. Arrangements applicable to presentations of medicinal products for which the reference price has been determined by the rules laid down in Article 4 (3) and (4) and placed on the market in another Member State of the European Union at a lower price.

1. The holder of the marketing authorisation or, where appropriate, the local representative in Spain responsible for the offer to the National Health System of the presentations of medicinal products whose reference price has been determined by the rules set out in Article 4 (3) and (4) and placed on the market in another Member State of the European Union at a price below the price set as a reference price in the relevant order for the annual update of the reference price system, you must communicate to the General Directorate of the Basic Portfolio of Services National Health and Pharmacy System of the Ministry of Health, Social Services and Equality, this lower price than is marketed in another Member State of the European Union. This communication shall be made within one month from the date of application of each annual order in respect of which the reference price system has been updated or from the date on which its marketing is initiated at a price. less if it occurs after the date of application of the corresponding order.

Failure to comply with the communication obligation under the previous paragraph shall be punishable under the sanctioning regime established by Law 29/2006 of 26 July.

2. When the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality is aware that a drug presentation is being marketed in some State Member of the European Union at an industrial price lower than that fixed as an industrial reference price in accordance with Article 4 (3) and (4), shall submit it to the following meeting of the Interministerial Committee for the Prices of Medicinal Products to agree to the revision of its price for the purpose of fixing as a new maximum industrial price for such presentation of the retail price to which it is being marketed in another Member State. The Directorate-General will issue a resolution setting out the financing conditions for this presentation with the new maximum industrial price set by the Inter-Ministerial Commission for the Prices of Medicinal Products. In the event that the currency of that Member State is not the euro, the change published by the Bank of Spain applicable on the 1st of the month in which the Inter-Ministerial Commission for the Prices of Medicinal Products meets.

The new maximum industrial price for this medicinal product presentation shall be collected in the official Nomenclator of the pharmaceutical supply of the National Health System applicable on the 1 day of the month following the date of the decision dictated by the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality.

Additional provision third. Reference prices for Gallic innovations of therapeutic interest declared prior to the entry into force of Royal Decree-Law 16/2012 of 20 April, of urgent measures to ensure the sustainability of the National Health System and improve the quality and safety of their performance.

1. The presentations of medicinal products for which galenic innovation of therapeutic interest has been declared prior to the entry into force of Royal Decree-Law 16/2012 of 20 April, shall be excluded from the reference price system in accordance with the regulations under which the innovation galenica was declared. The periods of exclusion of the reference price system for each of the product presentations shall be published as an annex to the successive orders for the annual update of the reference price system.

2. Once the exclusion period has elapsed as provided for in the previous paragraph, the presentations of medicinal products which have been declared as a galenic innovation shall be automatically incorporated into the corresponding sets, and shall be supply by the relevant marketing authorisation holder or, where appropriate, the local representative in Spain responsible for the offer to the National Health System at the relevant industrial reference price from the day after that period. These variations shall be included in the official Nomenclator of the pharmaceutical supply of the National Health System for the following month.

Additional provision fourth. Electronic communications.

All notifications and communications derived from the application of the reference price system and of homogeneous groupings regulated in this royal decree that the General Directorate of the Basic Portfolio of Services of the System National Health and Pharmacy must make marketing authorization holders or, where appropriate, local representatives in Spain responsible for the offer to the National Health System of presentations of medicinal products, to the distribution entities, to the General Council of the Official Colleges of Pharmacists and to the other In accordance with article 27.6 of Law 11/2007, of 22 June, of electronic access of citizens to the Public Services, through the electronic headquarters of the Ministry of Public Services, interested parties, as well as the actions of the interested parties, will be carried out. Health, Social Services and Equality (sede.msssi.gob.es).

Additional provision fifth. Registration of the effective date of marketing in the official Nomenclator of the pharmaceutical provision of the National Health System of the presentations of medicinal products already included in the pharmaceutical supply.

The registration of the date of effective marketing communicated in accordance with the provisions of Royal Decree 1345/2007 of 11 October 2007 in the official Nomenclator of the pharmaceutical supply of the National Health System of the Drug presentations that prior to the entry into force of this royal decree would have been included in the pharmaceutical provision of the National Health System, will be carried out on the basis of information from the Spanish Agency of Medicines and Health Products, and will be updated in the official Nomenclator of the provision pharmaceutical of the National Health System corresponding to day 1 of the third month after the entry into force of this royal decree.

Additional provision sixth. Communication of the effective date of marketing of drug presentations for the effectiveness of inclusion in the pharmaceutical delivery of the National Health System.

1. Once the corresponding resolution of the General Directorate of the Basic Portfolio of Services of the National System of Health and Pharmacy of the Ministry of Health, Social Services and Equality on the public funding of medicines is produced, the Inclusion of the presentations of medicinal products in the pharmaceutical provision of the National Health System shall have effects in accordance with the following rules, having regard to the date communicated for their effective marketing by the holder of his marketing authorisation in application of the provisions of Article 28 of the Royal Decree 1345/2007, dated October 11:

(a) If the effective date of marketing of a medicinal product is fixed between 1 and 15 of each calendar month, the effectiveness of its inclusion in the pharmaceutical provision of the National Health System and the Record of this situation in the official Nomenclator of the pharmaceutical delivery of the National Health System will occur on the 1st of the month after.

(b) If the effective date of marketing of a medicinal product is fixed between 16 and 31 of each calendar month, the effectiveness of its inclusion in the pharmaceutical provision of the National Health System and the of this situation in the official Nomenclator of the pharmaceutical provision of the National Health System will occur on Day 1 of the second month thereafter.

2. For the presentations of medicinal products included in the pharmaceutical supply of the National Health System at the entry into force of this royal decree, whose marketing authorization holder had not yet communicated the date of his/her effective marketing pursuant to Article 28 of Royal Decree 1345/2007 of 11 October 2007, the registration of the date of its effective marketing in the official Nomenclator of the pharmaceutical supply of the National System of Health shall be produced from its communication in accordance with the rules set out in previous.

3. Until the recording of the communication of the marketing effectivein the official Nomenclator of the pharmaceutical supply of the National Health System of the presentations of medicinal products included in the pharmaceutical supply, no The National Health System will be able to be dispensed with or invoiced.

Additional provision seventh. Individual price review of the presentations of medicinal products affected by the provisions of Article 3.2.

When in accordance with Article 3.2, no reference set could be created for at least one medicinal product other than the original and its licenses, the General Directorate of the Basic Portfolio of Services of the National Health System. and Pharmacy of the Ministry of Health, Social Services and Equality shall, within one year, proceed to the individual review of the price in accordance with Article 91 of Law 29/2006 of 26 July of the medicines included in the pharmaceutical provision of the National Health System having the same active substance and administration route affected.

Additional disposition octave. Medication dispensing regimen.

When the prescription is first performed, the pharmacist will dispense the lowest-priced drug from its homogeneous group. In the case of supply or urgent need, the available presentations must be dispensed with the lowest price. In case of a number of presentations which have the same price, the generic medicinal product or the corresponding biosimilar shall be dispensed if it is among them. Where the prescription is made by trade name, the same rules apply only if the price of the prescribed medicinal product exceeds the lower price of the homogeneous group.

Additional provision ninth. Security of supply to the pharmacy offices of the lower-priced medicines.

The holder of the marketing authorization shall have the obligation to have sufficient supply of the market, in an appropriate and continuous manner to enable compliance with the legally established requirements in the field The invention relates to a pharmaceutical delivery system for the National Health System and to the provision of pharmaceutical and pharmacy services for pharmaceutical presentations included in homogeneous, lower-priced and lower prices. Their non-compliance shall be punishable under the sanctioning regime established by Law 29/2006 of 26 July.

First transient disposition. Fixing the reference price for presentations of medicinal products for hospital and clinical packaging.

1. On a temporary basis and until the availability of aggregated information on hospital pharmaceutical expenditure of the National Health System, for presentations of medicinal products in hospital and presentations of medicinal products in clinical packaging to the with regard to Article 3.3, and which meet the requirements referred to in Article 4.4, the person holding the Ministry of Health, Social Services and Equality shall establish a reference price calculated on the basis of the duration of the packaging as to the dosage schedule set out in the technical tab, according to the following formula:

PVLRef = CTD minor × n. days of pack duration according to the dosage schedule set out in your technical tab

2. Where the aggregated information of the hospital pharmaceutical expenditure of the National Health System is available, the weighted reference price referred to in Article 4.4 shall be applied in these cases.

Second transient disposition. Application of the reference price system to medicinal products used in fluidotherapy and radiopharmaceuticals.

On a transitional basis and until aggregated information is available on the hospital pharmaceutical expenditure of the National Health System, no sets of drugs used in fluidotherapy or radiopharmaceuticals will be formed by their special features and use in the hospital environment.

Final disposition first. Competence title.

This royal decree is dictated by the provisions of article 149.1.16. of the Spanish Constitution, which attributes to the State exclusive competence in the field of legislation on pharmaceutical products.

Final disposition second. Development and execution faculty.

The head of the Ministry of Health, Social Services and Equality is empowered to make the necessary provisions for the development and execution of this royal decree.

Final disposition third. Entry into force.

This royal decree shall enter into force on the day following that of its publication in the "Official Gazette of the State", except the first paragraph of Article 8.2 which shall enter into force on the first day of the third month following its publication in the "Official State Gazette".

Given in Madrid, on March 21, 2014.

JOHN CARLOS R.

The Minister of Health, Social Services and Equality,

ANA MATO ADROVER