Further Extension Of The Insertion Of The Medicinal Product For Human Use "afamelanotide" In The List Of Medicinal Products Payable At The Full Shipment Of National Health Service Under The Act December 23, 1996, # 648. (Resolution No. 429/2015).

Original Language Title: Ulteriore proroga dell'inserimento del medicinale per uso umano«Afamelanotide» nell'elenco dei medicinali erogabili a totale caricodel Servizio sanitario nazionale ai sensi della legge 23 dicembre1996, n. 648. (Determina n. 429/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-29&atto.codiceRedazionale=15A03230&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The DIRECTOR-GENERAL having regard to articles 8 and 9 of legislative decree July 30, 1999, # 300; Visto l'art. September 30, 2003 48 of Decree-Law n. 269, converted into law November 24, 2003, n. 326, establishing the Italian medicines agency and, in particular, paragraph 13; Having regard to the Decree of the Minister of health in consultation with the Ministers for public administration and Economics and finance dated September 20, 2004, n. 245 laying down rules on the organisation and the functioning of the Italian Medicines Agency, pursuant to paragraph 13 of article. 48 above, and in particular art. 19; Having regard to the Decree of the Minister of health of November 8, 2011, recorded by the Central Office of the budget to the register «simple» Visas, sheet # 1282, dated November 14, 2011, with which he was appointed Director General of the Italian Medicines Agency. Luca Pani, as from November 16, 2011; Having regard to the Decree of the Minister of health September 28, 2004 which formed the technical and Scientific Advisory Committee of the Italian Medicines Agency; Having regard to law no December 23, 1996. 648, conversion of Decree Law No 536 October 21, 1996 concerning measures for the containment of pharmaceutical expenditure and determining the expenditure ceiling for the year 1996, published in the Official Gazette No. 300 of December 23, 1996; Having regard to the Commission's decision only (CUF) dated July 20, 2000, published in the Official Journal No. 219 of September 19, 2000 with errata in Official Gazette No. 232 of October 4, 2000, concerning the establishment of the list of innovative medicines whose marketing is authorized in other States but not on the national territory, of medicinal products which have not yet permitted but subjected to clinical trials and medicines to be used for a therapeutic indication other than that authorised, to be the sole responsibility of the national health service where there is no valid alternative therapy in accordance with art. 1, paragraph 4, of Decree Law October 21, 1996 # 536, converted by law December 23, 1996 # 648; Seen yet the measure CUF dated January 31, 2001 clinical medicines placed on the monitoring on the abovementioned list, published in Official Gazette No. 70 of March 24, 2001; Having regard to the Italian medicines agency determination dated May 5, 2010, published in the Official Journal No. 112 of May 15, 2010 concerning the inclusion, on the abovementioned list of medicine afamelanotide, in the absence of valid alternative therapy available, for the therapeutic indication: "treatment of Erythropoietic Protoporphyria" and with the following time limit: up to approval of the application for marketing authorisation, or for a maximum of 24 months; Having regard to the Italian medicines agency determination dated May 2, 2012, published in the Official Journal No. 113 of May 16, 2012, on the extension of the insertion, on the abovementioned list of medicine afamelanotide considering the dossier for marketing authorisation request had been deposited to the EMA in February 2012 and he foresaw a process about a year; View also the determination of the Italian Medicines Agency dated April 18, 2014, published in the Official Journal No. 103 of May 6, 2014, on the extension of 12 months of insertion on the abovementioned list of medicine afamelanotide; Considered, however, to attribute to this medicine an important therapeutic innovation, why are intended for treatment of a disease so far deprived of proper treatment and, if so, exclusion would be denied to patients the chance to undertake or continue such therapy; Taking into account the decision taken by the scientific and Technical Advisory Committee (CTS) of March 25, 2015 at its meeting on 24 and 23, AIFA, as per section report No. 36; Was therefore considered to extend the stay of the medicine afamelanotide referred to the determination of the AIFA dated May 5, 2010, cited above, in the list of medicinal products granted sole responsibility of national health service established under the Act December 23, 1996, # 648;
Causes: Art. 1 the inclusion of medicine afamelanotide, to whose determinations of AIFA mentioned premise, in the list of medicinal products granted sole responsibility of national health service established under law No 648/96, is hereby extended, pending the submission of the listings there's request by the company, until June 30, 2015, in accordance with the conditions for it in annex 1 which is an integral part of this determination.