Article 93 of Law 29/2006 of 26 July on guarantees and the rational use of medicinal products and medical devices establishes the system of reference prices in the financing of public funds for prescribed medicinal products and dispensed through the official medical prescription of the National Health System. The legal precept entrusts the Minister of Health, Social Policy and Equality, with the agreement of the Government Delegation for Economic Affairs and the report of the Interterritorial Council of the National Health System, the determination of these (a) a set of joint ventures which serve as the basis for the fixing of the reference prices, as well as the value of the reference prices.

That same article, in the wording given by Royal Decree-Law 4/2010, of March 26, of rationalization of pharmaceutical expenditure under the National Health System, provides that the reference price will be, for each set, the cost/treatment/day less than the presentations of medicinal products in the grouped by each route of administration, calculated according to the defined daily dose. This is why it is necessary to set the sets and their respective reference prices in accordance with the new rules applicable to the reference price system.

Similarly, Article 93 specifies that the determination of new reference prices and sets, as well as the revision of the reference prices for certain sets, will be carried out at least once a year. year, and therefore taking into account, moreover, that the cited Royal Decree-Law 4/2010, of 26 March, also proceeded to amend Article 91 of Law 29/2006, of 26 July, in order to delete the sixth paragraph of it, it is concluded that it is possible to make use of the power granted by Article 93 of the Law.

Moreover, and in accordance with the first paragraph of Article 93 (2), as amended by the final provision of Law 34/2010 of 5 August of 5 August, amending Law No 30/2007 of 30 October 2000, Public Sector Contracts, 31/2007, of 30 October, on procurement procedures in the water, energy, transport and postal services sectors, and 29/1998 of 13 July, regulating the Contentious Jurisdiction- Administrative provisions for adaptation to Community legislation of the first two may be set up when ten years have elapsed since the initial date of the authorisation of the medicinal product in Spain or 11 in the case of a new indication.

Consequently, by this order, it is necessary, for the purposes of complying with the provisions of Article 93 of Law 29/2006 of 26 July, to determine the sets of medicinal products and their reference prices, for which it also sets the formula for calculating the latter.

In addition, in accordance with the authorisation referred to in the second paragraph of Article 93 of Law 29/2006 of 26 July, and in view of the fact that Royal Decree 1338/2006 of 21 November, which was aspects of the aforementioned article in the framework of the reference price system, has been annulled by virtue of the judgment of 9 March 2010, of the Third Chamber of the Supreme Court, published in the "Official Gazette of the State" No 107 of 3 May In 2010, Articles 3, 4 and 5 of this Ministerial Order regulate the assumptions, requirements, the procedure and effects of the declaration of galenic innovation of therapeutic interest. Similarly, and for the purpose of avoiding the undesirable damage which could be derived from the revocation of all the statements of Greek innovation agreed under the Royal Decree, it is necessary to validate, by means of the additional provision Eighth, all of those Gallic innovations which would have been declared in accordance with the procedure laid down in that Royal Decree. All this, in turn, motivates the need to include in the text three transitional provisions regulating the effects of the gallic innovations of therapeutic interest declared prior to the entry into force of this order. (transitional provision first), the proceedings initiated under the Royal Decree annulled and which, consequently, have not been resolved (second transitional provision), as well as for the establishment of a procedure and the granting of a period of time to those proceedings. new pharmaceutical forms which have been authorised from three months before the date of cancellation of the Royal Decree cited, and until the entry into force of this order, provided that this declaration has not been requested (third transitional provision).

Of the above, and taking into account that there are certain presentations of medicinal products whose declaration as a gallic innovation shall expire within 12 months of the date of entry into force of this Regulation. Article 6 provides for its incorporation into the reference price system, in accordance with the provisions of Article 93.2 of Law 29/2006 of 26 July, in conjunction with Article 5 of this Order, allowing for the exercise of the option provided for in the aforementioned Article 93.5 of Law 29/2006.

Regarding the assumptions and the procedure to make the price reduction of those medicines whose industrial price in application of the reference price system affected by more than fifty percent effective, In the light of the fact that they were questions contained in Royal Decree 1338/2006 of 21 November cited above, they are governed by Article 7 of that Order by virtue of the habilitation conferred by the second paragraph of Article 93 of Law 29/2006, 26 of July, enabling, by way of the fifth additional provision, the exercise of the option provided for in Article 93.5 of the same Law.

This order also incorporates, for the purposes of the formation of certain assemblies, 86 presentations of generic medicinal products subject to precautionary measures of immobilization as a result of judicial judgment given in the procedure for the protection of industrial property rights. These sets shall not produce any effects until such time as a presentation of a generic marketed medicinal product which is not affected by a precautionary measure of immobilisation, or is notified, by the Court or judged to the Ministry of Health, is included. Social policy and equality, the final judgment in order to dismiss the claims of the holder of the patent of the medicinal product or the order in which the precautionary measures for immobilisation of the generic medicinal product are not taken into effect, for which entered the corresponding annotation in the official Nomenclator of pharmaceutical products of the National Health System. If the judgment is in favour of the interests of the holder of the generic medicinal product, or the incorporation of a presentation of a generic marketed medicinal product not subject to precautionary measures of immobilization, the annotations shall be deleted, applying to the presentations contained in those sets the provisions referred to in this Standard. Otherwise, the sets remain inactive until they are deleted, if any, by the corresponding review order.

In another area, and in order to facilitate the exercise of the option referred to in Article 93.5, as well as to present the option of voluntary price reductions without modification of the National Code, or any other act that be understood with the Administration, as provided for in the sixth provision of this project, the communications of the laboratories shall be directed by means of telematic registration, in accordance with Article 27.6 of Law 11/2007, On 22 June the Council adopted a proposal for a Council Regulation on the that this order is addressed to legal persons or groups of natural persons who are guaranteed access to and availability of the precise technological means.

Finally and to facilitate the application of the provisions of Articles 85, 86 and 93.4 of Law 29/2006, this order establishes that the official Nomenclator of pharmaceutical products of the National Health System will incorporate the groups of presentations of medicinal products, whether or not included in the reference price system, the lower price of the medicinal product being the lower value of all the presentations of each group. For this information, the last update of which was included in the Nomenclator of July 2010, the order establishes its update on the same date from which the new reference prices are settled with the new reference prices National of Health, should be informed next to the Nomenclator one month in advance.

in its preparation, the Autonomous Communities have been consulted and the sectors affected have been consulted prior to the Interterritorial Council of the National Health System and the Advisory Committee, and the Agreement of the Government Delegation for Economic Affairs.

In its virtue, according to the State Council, I have:

Article 1. Reference sets and prices.

In application of Article 93.2 of Law 29/2006, of July 26, of guarantees and the rational use of medicines and medical devices, the sets and their reference prices are those that are related in this order, in Annex 1, both the existing sets, the new prices obtained after their revision, and the newly created sets.

Article 2. Formula of calculation of reference prices.

For the calculation of the value of the reference price in each set, the following shall be taken into account:

a) The presentation of the drug will be selected with the lowest cost/treatment/day.

b) The defined daily doses are those listed in Annex 2.

By virtue of the power conferred by the second paragraph of Article 93.2 of Law 29/2006 of 26 July, the minimum threshold for reference prices is fixed at EUR 3,12 for the sale price to the public, including taxes. object of this order.

Article 3. Requirements for the declaration of galenic innovation of therapeutic interest.

1. In order to declare a medicinal product as a galenic innovation of therapeutic interest, at least one of the following requirements must be met:

(a) that the medicinal product is presented for the first time under a different route of administration than that authorised and that this new route would lead to a significant improvement in the therapeutic utility of the product, based on its efficacy, safety or utility in special populations.

(b) That, even if it is presented under an already authorised route of administration, it is shown that the new galenic product incorporated in the medicinal product adds a significant improvement in the therapeutic utility of the product, based on its efficacy, safety or utility in special populations.

2. The therapeutic advantages, improvements and facilities referred to in the preceding paragraphs shall be the subject of assessment and declaration by the Spanish Agency for Medicinal Products and Sanitary Products, as provided for in Article 4 of this Regulation. order.

3. Medicinal products complying with the definition of a generic medicinal product or medicinal products for which generic formulation with the same composition is not available may not be declared as a gallic innovation of therapeutic interest. qualitative and quantitative in principle active and the same pharmaceutical form.

Article 4. Procedure for the application, assessment and resolution of galenic innovation of therapeutic interest.

1. The procedure shall be initiated at the request of a person concerned to the Spanish Agency for Medicinal Products and Sanitary Products within three months of the date of the approval of the new pharmaceutical form, in accordance with the provisions of the Chapter II of Title II of Law 29/2006 of 26 July. For medicinal products which have been authorised by centralised procedure, the preceding period of three months shall start from the date of the communication of the Spanish Agency for Medicinal Products and Sanitary Products definitive packaging for placing on the market in Spain and the allocation of a national code. The application, which may be lodged in any of the places provided for in Article 38.4 of Law No 30/1992 of 26 November 1992, of the Legal System of Public Administrations and of the Common Administrative Procedure, shall be justified by the compliance with the criteria set out in Article 3 of this Order.

2. The Agency shall issue a motion for a resolution and the hearing shall be initiated in accordance with Article 84 of that Law No 30/1992 of 26 November.

3. The decision of the holder of the Spanish Agency for Medicinal Products and Sanitary Products shall be issued and notified within a period of no more than six months from the date of entry of the application into the register of the Agency, and shall end the administrative.

Article 5. Effects of the declaration of galenic innovation of therapeutic interest.

1. Medicinal products declared as gallic innovations shall be excluded from the reference price system for a period of five years from the date of entry into force of the ministerial order determining the whole corresponding to its active principle and reference price. After that period, they shall be integrated into the reference set.

2. In the event that the said qualification is subsequent to the creation of the set corresponding to the active principle and the reference price, the five-year exclusion period shall be computed from the date of the declaration of galenic innovation, The price that the medicinal product had before the creation of the whole was to be restored from that moment on.

Article 6. Medicinal products whose declaration as a galenic innovation expires from the entry into force of this order.

1. The presentation of medicinal products for which the declaration as a gallic innovation expires from the date of entry into force of this order shall be incorporated in the corresponding sets from the first day of the month following the expiry of the said procedure. a declaration, in accordance with the provisions of Article 93.2 of Law 29/2006 of 26 July, in conjunction with Article 5 of this Order.

2. For information purposes to facilitate their implementation and monitoring, the presentations of medicinal products whose declaration as a galenic innovation expires in the period from December 2010 to December 2010 are listed in Annex 3 to this Order. November 2011, as well as the date of its expiry.

Article 7. A reduction of more than 50% of the industrial price in application of the reference price system.

1. The pharmaceutical laboratories holding the presentations of medicinal products whose industrial prices are affected by a percentage of more than 50% as a result of the application of the reference price system, must relate in the Annex to the relevant reference price order, together with the presentation of the medicinal product concerned and its respective reference price.

Those laboratories may choose, as provided for in Article 93 (5) of Law 29/2006, to assume all the reduction on the date of entry into force of the ministerial order or to do so in two years, at least one year. Fifty percent of the price per year, until the reference price is reached.

2. Where the pharmaceutical laboratory decides to take the reduction of the industrial price of the medicinal product at a minimum of 50% of the price per year, it shall exercise that option within 10 calendar days of the date of entry into force of the corresponding order.

For such purposes, the pharmaceutical laboratory must formally communicate the decision to the Directorate General of Pharmacy and Health Products of the Ministry of Health, Social Policy and Equality, specifying in that communication the annual quantity for which the respective products are to be dispensed until the reference price is reached for each application.

The date on which the communicated quantity will be effective will be set in the corresponding reference price order.

Additional disposition first. Set inactivity.

1. The assemblies referred to as inactive in Annex 1 shall not produce any effect as long as a presentation of a generic marketed medicinal product not subject to precautionary measures for immobilisation or notification by the Court or Judgment of the Ministry of Health, Social Policy and Equality, the final judgment in order to dismiss the claims of the holder of the patent of the medicinal product or the order for which the precautionary measures for immobilisation of the medicinal product are to be taken without effect generic.

2. This circumstance will be noted in the official Nomenclator of pharmaceutical products of the National Health System. Once one of the assumptions referred to in the preceding paragraph is present, the previous annotation shall be cancelled and the appropriate express declaration of activation of the assembly shall be made to record it, applying to the presentations contained in such sets of the provisions contained in this order.

Additional provision second. Presentations of generic medicines with a price higher than the reference price and medicines that do not have the same generic medicinal product presentations.

1. In accordance with the provisions of Article 93.3 of Law 29/2006 of 26 July of 26 July, in the period of 50 calendar days from the date of entry into force of the order, the presentation of generic medicinal products with a higher price than that of the reference shall be supplied by the laboratories at an industrial price corresponding to one or less of the reference. In these cases, the national code for the presentation of the medicinal product shall not be amended.

2. The above paragraph shall also apply to the presentation of medicinal products with a higher price than the reference price which do not have the same generic medicinal product presentations, for the purpose of the replacement provided for in the Article 93.4 of the said law and as long as the situation of non-availability is maintained.

3. In the case of the presentations of medicinal products concerned by paragraph 1 of the first provision of this order, the preceding paragraphs shall apply within the period of 50 calendar days from the date of notification by the Ministry of Health, Social Policy and Equality, to all interested parties, the express declaration referred to in paragraph 2 of the first provision. Where necessary, the time limit shall be extended by reason of the requirements for the management of the pharmaceutical provision of the National Health System until such time as the end of the calendar day of the month concerned.

Additional provision third. Voluntary price reductions without modification of the National Code.

1. The laboratories that voluntarily decide to commercialize the drug presentations at a lower price than the authorized one to adapt it to a level equal to or lower than the reference level, without modifying the National Code, must inform the Directorate-General for Pharmacy and Health Products of the Ministry of Health, Social Policy and Equality within 10 calendar days of the date of entry into force of the order.

2. The presentations of medicinal products referred to in the previous paragraph shall be supplied by the laboratories at the new price within 50 calendar days from the date of entry into force of the order.

3. In the case of the presentations of medicinal products concerned as provided for in paragraph 1 of the first provision of this order, paragraph 1 of this provision shall apply within 10 calendar days and paragraph 2 shall apply. within the period of 50 calendar days, both of which have been counted since the notification by the Ministry of Health, Social Policy and Equality, to all concerned, of the express declaration referred to in paragraph 2 of the additional provision first.

4. The medicinal products concerned by the provisions of Article 6 of this Order shall be subject to the provisions laid down in paragraphs 1 and 2 of this Article. In such cases, the period laid down in paragraph 1 shall apply on the same terms. However, the provisions of paragraph 2 may apply from the 50 calendar days prior to the date of expiry of the declaration of galenic innovation as set out in Annex 3, be supplied in any event from the first day of the month following that in which the said expiry occurs.

Additional provision fourth. Price applicable to the presentations of medicinal products concerned by the provisions of Article 93 (6) and (7) of Law 29/2006 of 26 July.

From the fifty calendar days from the date of entry into force of the order, the presentations of medicinal products affected by the provisions of paragraphs 6 and 7 of Article 93 of Law 29/2006, of 26 July, which are listed in Annex 4, they shall have the industrial price set out in that Annex, without it being necessary to amend their national code.

Additional provision fifth. Industrial prices affected by the reference price system by more than fifty percent.

1. The pharmaceutical laboratories holding the medicinal products listed in Annex 5 which, in accordance with Article 93.5 of Law 29/2006 of 26 July of 26 July, in conjunction with Article 7 (1) of this Order, decide assume the reduction resulting from the application of the reference price system to the industrial prices of their products at a minimum of 50% per year, they shall exercise that option in accordance with the provisions of paragraph 2 of the Article 7 and the sixth provision of this order. The quantity communicated shall be effective from the fifty calendar days from the date of entry into force of the order.

2. In the case of the presentations of medicinal products concerned as provided for in paragraph 1 of the first provision of this order, the time limits referred to in the preceding paragraph shall be taken into account from the time of notification. by the Ministry of Health, Social Policy and Equality, to all interested parties, the express declaration referred to in paragraph 2 of the first provision. Where necessary, the time limit shall be extended by reason of the requirements for the management of the pharmaceutical provision of the National Health System, until such time as the end of the calendar day of the month concerned.

3. Pharmaceutical laboratories holding the medicinal products concerned by the provisions of Article 6 of this Order which relate to Annex 6, and which decide to take the reduction resulting from the application of the reference price system to the industrial prices of their products at a minimum of 50% per year, may exercise such an option in the terms and time limits laid down in the first paragraph. However, in these cases, the quantity communicated shall be effective from the first day of the month following that in which the declaration of the Greek innovation expires.

Additional provision sixth. Acts of communication with the Administration.

For all the actions that the laboratories have to perform with the Administration in accordance with the provisions in this order, those must present the communications by means of telematic registration through of the link http://registrotelematico.mspsi.es/, in application of the provisions of article 27.6 of Law 11/2007, of June 22, of electronic access of citizens to public services.

Additional provision seventh. Lower prices of drug presentations for dispensing and replacement by the pharmacist.

1. In order to facilitate the application of the cases of supply and replacement by the pharmacist provided for in Articles 85, 86 and 93.4 of Law 29/2006 of 26 July, the official Nomenclator of pharmaceutical products of the National Health System incorporate the information of the groupings of the presentations of medicinal products, whether or not included in the reference price system. For these purposes, the lowest price medicinal product shall be the price of the lower price of the product of the presentations included in each group.

2. The information on the minor prices referred to in the preceding paragraph shall be updated on the day following the end of the period referred to in paragraph 1 of the fifth transitional provision of this order. For information purposes, this update shall be related to the Nomenclator one month in advance of the date of its effectiveness.

3. If the variations experienced in the prices of the medicinal products so advise, and after agreement of the Permanent Commission of Pharmacy of the Interterritorial Council of the National System of Health, the information mentioned in the may be reviewed at the time the circumstances permit, and may affect that update either to the entire list included in the relationship or to the exchange groups deemed appropriate. For information purposes, this update shall be related to the Nomenclator one month in advance of the date of its effectiveness.

Additional disposition octave. Validation of the Welsh innovations declared under Royal Decree 1338/2006 of 21 November.

In accordance with the provisions of Article 93.2 of Law 29/2006 of 26 July, the declarations as a gallic innovation of therapeutic interest for the medicinal products concerned which would have been determined under the provisions of the provisions of the by Royal Decree 1338/2006 of 21 November, shall be deemed valid from the time of their declaration and shall continue to take effect.

First transient disposition. Effects of the galenic innovations of therapeutic interest declared prior to the entry into force of this order.

1. The presentation of medicinal products which have been declared as a galenic innovation of therapeutic interest prior to the entry into force of this order shall, from the date of entry into force, be excluded from the application of the system of reference prices taking into account the dates listed in Annex 7, which also includes the presentations set out in Annex 3 to this Order.

2. In the case of inactive declared assemblies, the periods of exclusion of the reference price system shall be deemed to be suspended from the date of inactivation of the corresponding set, the time of which shall be resumed once the activation of the same in accordance with paragraph 2 of the Additional Disposition first of this order.

Second transient disposition. Requests for statements of galenic innovation of therapeutic interest pending the entry into force of this order.

The procedures initiated prior to the entry into force of this order and pending resolution shall be governed in accordance with the provisions of this order.

Transitional provision third. Deadline for the submission of applications for declarations of galenic innovation of therapeutic interest for new pharmaceutical forms which have been authorised between 9 December 2009 and the entry into force of this order.

A period of 15 calendar days is granted from the entry into force of this order in order to submit applications for a declaration of galenic innovation of therapeutic interest to the holders of new pharmaceutical forms which have have been authorised between 9 December 2009 and the entry into force of this order and have not requested such a declaration.

Transitional disposition fourth. Price coexistence and stock return.

1. The stocks of medicinal products affected by the price reductions provided for in this order which are held by the warehouses may continue to be placed on the market at the price before this reduction in the period of 70%. calendar days following the date of the order's entry into effect.

2. The stocks of medicinal products affected by the price reductions provided for in this order in the possession of the pharmacy offices may continue to be placed on the market at the price before this reduction in the period of the 90 calendar days following the date of entry into force of the order. If necessary, the time limit shall be extended, due to requirements for the management of the pharmaceutical provision of the National Health System, until the end of the period with the last calendar day of the corresponding month. In the latter case, the period in which the initial period is extended shall be divided equally between the warehouses and the offices of pharmacy, except where this is not possible, in which case the half plus one day of that period The office of pharmacy shall be responsible.

3. Under the provisions of Article 6.2.5 of Royal Decree 726/1982 of 17 March 1982 regulating the expiry and return of proprietary medicinal products to pharmaceutical laboratories, distribution stores and offices of pharmacy, without any additional cost to them, may be returned to the pharmaceutical laboratories, from the day following the end of the period referred to in the preceding paragraph and in accordance with Article 8 of the said Royal Decree, stocks of the presentations with price on the packaging before the reductions set in this order.

4. In the case of the presentations of medicinal products concerned by the provisions of paragraph 1 of the first provision of this order, the time limits referred to in the preceding paragraphs shall be taken into account from the time when the notify the Ministry of Health, Social Policy and Equality, to all interested parties, of the express declaration referred to in paragraph 2 of the first provision.

Transient disposition fifth. Expenditure financed from public funds.

1. 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 Judicial Mutuality (MUGEJU), will maintain, during the the period of the 90 calendar days following the date of entry into force of the order, the previous price of the medicinal products concerned as laid down in the additional, second, third and fourth provisions in respect of this provision second transitional period, for the purposes of invoicing and in respect of the part of the of the expenditure directly satisfied by that system. Where necessary, the time limit shall be extended by reason of the requirements for the management of the pharmaceutical provision of the National Health System, until such time as the end of the calendar day of the month concerned.

2. The new charges shall be settled with the new prices for the National Health System, including the special arrangements referred to in the previous paragraph, which shall be closed from the day following the end of the period referred to in paragraph 1. previous.

3. In the case of the presentations of medicinal products concerned by the provisions of paragraph 1 of the first provision of this order, the time limits referred to in the preceding paragraphs shall be taken into account from the time when the notify the Ministry of Health, Social Policy and Equality, to all interested parties, of the express declaration referred to in paragraph 2 of the first provision. Where necessary, due to the requirements relating to invoicing, both time limits shall be extended until the end of the calendar day of the month concerned, respectively, and the first day of the following month.

Single repeal provision. Regulatory repeal.

As many rules of equal or lower rank are repealed, they are opposed to the provisions in this order.

Final disposition first. Competence title.

This order is issued under the state competition law on pharmaceutical products, in accordance with the provisions of Article 149.1.16. of the Constitution.

Final disposition second. Entry into force.

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

Madrid, November 26, 2010. -Minister of Health, Social Policy and Equality, Leire Pajin Iraola.

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