Insertion Of The Medicinal Product For Human Use "methylphenidate (Ritalin)" In The List Of Medicinal Products Granted Sole Responsibility Of National Serviziosanitario Under The Act December 23, 1996, # 648, For The Treatment Of Attention Deficit Diso...

Original Language Title: Inserimento del medicinale per uso umano «Metilfenidato (Ritalin)»nell'elenco dei medicinali erogabili a totale carico del Serviziosanitario nazionale, ai sensi della legge 23 dicembre 1996, n. 648,per il trattamento del disturbo da deficit dell'atte...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-11&atto.codiceRedazionale=15A03435&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 the Official Gazette No. 70 of March 24, 2001; Considered appropriate to provide adequate therapeutic continuity to adult patients with attention deficit and hyperactivity disorder (ADHD) drug treatment already before the age of eighteen years of age; Considered appropriate to allow adults suffering from this disease treatment with said medicine 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 opinion expressed by the scientific and Technical Advisory Committee (CTS) 21-23 2014 at its meeting July AIFA-excerpt from the minutes # 27; Was therefore considered to include the medicine «methylphenidate (Ritalin) "in the list of medicinal products granted sole responsibility of national health service established under the Act December 23, 1996 # 648, for the therapeutic indication mentioned in the introduction;
Causes: Art. 1 The medicine «methylphenidate (Ritalin)» is entered in accordance with art. 1, paragraph 4, of Decree-Law No October 21, 1996. December 23, 1996, 536, converted by law No. 648, on the list established by Commission decision only the drug mentioned in the introduction.