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 the rules of organisation and operation 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 "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 on official journal # 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 authorized , to be the sole responsibility of the national health service where there is no therapeutic alternative, pursuant to art. 1, paragraph 4, of Decree-Law No October 21, 1996. 536, converted by law No 648 December 23, 1996; Seen yet the measure CUF dated January 31, 2001 clinical medicines placed on the monitoring on the abovementioned list, published in the Official Gazette No. 70 of March 24, 2001; Given that cysteamine administered orally has no effect on the intracorneale deposition of cystine crystals due to corneal vascularization and therefore there is currently an alternative therapy equivalent to cysteamine for ophthalmic use for the prevention and removal of corneal deposits of crystals of cystine in nephropathic cystinosis; Considered that the medicine Cystadrops it was designated an orphan drug by the European Commission (EC) on November 7, 2008 (EU/03/08/578) and that it's being obtaining centralized marketing at the European Medicines Agency (EMA); Considered appropriate to allow individuals who are in those conditions and which require the prescription of medicinal said the sole responsibility of the national health service; Considered it necessary to dictate the conditions under which such medicine is included in the list referred to in decision dated July 20, 2000 on the creation of the list; Taking into account the decision taken by the scientific and Technical Advisory Committee (CTS) 10-11 2014 at its meeting November AIFA-excerpt from report No. 30; Was therefore considered to include the medicine cysteamine hydrochloride (Cystadrops) in the list of medicinal products granted sole responsibility of national health service established under the Act December 23, 1996, # 648, for therapeutic indications mentioned in the introduction;
Causes: Art. 1 The medicine CYSTEAMINE hydrochloride (Cystadrops) is entered in accordance with art. 1, paragraph 4, of Decree Law October 21, 1996, # 536, converted by law no December 23, 1996. 648, on the list established by Commission decision only the drug for therapeutic indications mentioned in the introduction with a time limit of 18 months.