The reference price system, applicable to the financing of medicines by the National Health System, established in Article 93 of Law 29/2006, of 26 July, of guarantees and rational use of the medicines and medical devices, has been manifested as an essential tool for controlling pharmaceutical expenditure, which is necessary for the sustainability of the public health system.

The amendment introduced in Article 93, by article 4.10 of Royal Decree-Law 16/2012 of 20 April, of urgent measures to ensure the sustainability of the National Health System and improve quality and (a) to ensure that the legal mandate for establishing, on an annual basis, the new sets of rules is necessary to enable the legal mandate to be established on an annual basis. the reference for medicinal products as well as for the review of the reference prices of the In the case of the case-law of the Court of Law, the Court of State held that the Court of State held that the Court of State held that the Court of State held that the Court of State held that the Court of information on the financing and pricing of medicinal products and medical devices.

Article 5.1 of the aforementioned Royal Decree 177/2014, of 21 March 2014, entrusts the head of the Ministry of Health, Social Services and Equality, who, on an annual basis, by means of a corresponding order and after of the Government's Delegated Committee for Economic Affairs, establish the new sets and their reference prices, as well as review the reference prices for the presentations of medicinal products included in the existing sets and, in their case, proceed to the deletion of the sets when they no longer meet the requirements required for their establishment.

The last update of the reference sets of medicines and their reference prices was produced by the Resolution of 28 December 2011, by the Directorate General of Pharmacy and Health Products, by the the new sets of medicinal products to be dispensed in pharmacy offices through official medical prescription or dispensing order, their reference prices, and the reference prices fixed by Order SPI/30 52/2010 are determined, of 26 November and of the Resolution of 28 December 2011, of the Directorate-General for Pharmacy and Health Products, determining the new sets of medicinal products in the hospital and their reference prices.

Through this ministerial order the updating of the sets and reference prices established by the two resolutions mentioned above is carried out, and for this the new sets are determined and their prices are fixed reference, as well as the reference prices fixed by them. It is also appropriate to delete the reference sets previously determined by failure to comply with the requirements for their establishment due to overcome causes.

For the establishment of new reference sets of medicines and the maintenance of the sets established by means of the two resolutions of December 28, 2011, of the Directorate General of Pharmacy and Products The provisions set out in Article 3 of Royal Decree 177/2014 of 21 March 2014 have been taken into account for the deletion of reference sets, as well as for the deletion of reference sets.

For the fixing of the reference prices of the presentations of drugs integrated in the new reference sets of medicines and for the review of the reference prices of the presentations of medicinal products The provisions laid down in Article 4 of the said Regulation have been followed in accordance with Article 4 of that Regulation.

This order is issued in accordance with the specific rating provided for in Article 5.1 of Royal Decree 177/2014 of March 21, and in the process of hearing it has been transferred to the health administrations of the communities. (a) to the pharmaceutical companies concerned, to the pharmaceutical laboratories concerned, to the pharmaceutical companies concerned, to the pharmaceutical companies concerned, and to the entities representing the sectors concerned; affected, including consumer and user associations.

In its virtue, I resolve:

First.

Set new reference sets and reference prices for drug presentations included in them as well as review reference prices for drug presentations included in the previously existing sets.

In Annex 1 of this order reference sets of medicinal product presentations dispensed by pharmacy offices through official medical prescription or dispensing order, with indication of the price reference industry and PVPIVA reference fixed for each presentation.

The listed sets of C-231 to C-426 of the said Annex are newly created.

In Annex 2 of this order, reference sets of hospital-level drug presentations and presentations in clinical packaging are related, with indication of the industrial reference price and PVPIVA of reference fixed for each presentation.

The listed sets of H-69 to H-98 and EC-1 to EC-137 are newly created.

For the purpose of facilitating compliance with the provisions of the additional provision of Royal Decree 177/2014 of 21 March 2014, Annexes 1 and 2 identify the presentations of medicinal products whose reference price has been determined by the rules laid down in Article 4 (3) and (4) of that royal decree.

Second.

For information purposes, in Annex 3 of this order, all reference sets of medicinal products with indication of the reference price of each set (PRC) are related, identifying the presentation of medicinal products. cost/treatment/day (CTD) has determined the same.

Also included are the information of the defined daily doses (DDD) of each reference set of drugs used for the calculation of the cost/treatment/day (CTD) of the presentations of drugs integrated into the the same as in Article 4 of Royal Decree 177/2014 of 21 March 2014.

Also, reference sets of medicinal products formed by the existence of a biosimilar medicinal product and those formed without the existence of a generic or biosimilar medicinal product as established are identified. In Article 3 of Royal Decree 177/2014, of 21 March.

Third.

In application of the provisions of Article 5 of Royal Decree 177/2014, the reference sets of medicinal products which no longer meet the requirements for their establishment are deleted from 21 March 2014.

In Annex 4 of this order reference sets of deleted drugs are related, with indication of the reason for their deletion.

Fourth.

In Annex 5 of this order, the presentations of drugs declared as Gallic innovations of therapeutic interest are related before the entry into force of Royal Decree-Law 16/2012 of 20 April, of measures urgent to ensure the sustainability of the National Health System and to improve the quality and safety of its benefits, excluded from the reference price system, the declaration of which as a Greek innovation expires after the date of effects of this order.

In Annex 5, as set out in paragraph 1 of the additional provision of Royal Decree 177/2014 of 21 March 2014, the period for the exclusion of the reference price system for each of the Member presentations of medicinal products. After the expiry of the period of exclusion, the provisions of paragraph 2 of that provision shall apply.

Fifth.

For the purposes of the provisions of the additional provision seventh of Royal Decree 177/2014, of 21 March in Annex 6 of this order, the presentations of medicinal products and their licenses for which they have not been formed are related. Reference in accordance with the provisions of Article 3.2 of that royal decree.

Sixth.

For the purposes of applying the provisions of Article 5.3 of Royal Decree 177/2014 of 21 March 2014, the reference price is fixed for the presentations of medicinal products included in the pharmaceutical supply of the system National of Health prior to the date of effect of this order, but whose effectiveness of inclusion in the pharmaceutical provision, as provided in the additional provision sixth of the royal decree, had not been produced to date 10 April 2014, the start date of the procedure for the elaboration of this order.

In Annex 7 of this order, the presentations of medicinal products with indication of the reference set in which they will be integrated are related, the reference industrial price and the reference PVPIVA fixed for each presentation.

Seventh.

This order will produce effects from the day of its publication in the "Official State Bulletin".

Eighth.

Against this order, which ends the administrative route, a judicial-administrative appeal may be brought within two months from the day following that of its publication before the Chamber of -Administrative dispute of the National Court, in accordance with the provisions of Article 11 of Law No 29/1998 of 13 July, regulating the Jurisdiction-Administrative Jurisdiction or, as a matter of prior character, an appeal Administrative procedure for replacement within one month before the Minister for Health, Social Services and Equality, in accordance with the with the provisions of Articles 116 and 117 of Law No 30/1992 of 26 November 1992 on the Legal Regime of Public Administrations and the Common Administrative Procedure.

Madrid, July 10, 2014. -Minister of Health, Social Services and Equality, Ana Mato Adrover.

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