Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-01-03&atto.codiceRedazionale=14A09812&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; 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. the aforementioned 48 as amended by order No. 53 of the Minister of health, in consultation with the Ministers for public administration and simplification and of economy and Finance of the March 29, 2012; Having regard to the Legislative Decree March 30, 2001, n. 165; Having regard to act July 15, 2002, # 145; 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 act December 24, 1993, no. 537 concerning "public finance" corrective action with particular reference to art. 8; Visto l'art. 1, paragraph 40, December 23, 1996, law n. 662 laying «rationalization measures of public finance ", which identifies the margins of distribution for pharmaceutical companies, wholesalers and pharmacists; Visto l'art. 48, paragraph 33, November 24, 2003, law No. 326, which has negotiating the price for products reimbursed by the national health service between agency and marketing authorisation holders; Having regard to the Legislative Decree of April 24, 2006, n. 219, published in the Gazzetta Ufficiale della Repubblica italiana n. 142 of June 21, 2006 on the introduction of Directive 2001/83/EC (and subsequent amending directives) on the Community code relating to medicinal products for human use and Directive 2003/94/EC, and in particular art. 14 paragraph 2 which provides for the non-inclusion for the equivalent patented medicines therapeutic indications; Having regard to the Decree-Law no April 28, 2009 39, converted into law June 24, 2009, # 77, with whom art. 13 paragraph 1, point b) is restated the share attributable to drug companies, as provided for in art. 1, section 40 of the Act December 23, 1996, n. 662, 58.65 percent of the retail price exclusive of value added tax; Having regard to the 1 February 2001 CIPE; View the "notes October 29, 2004 determination AIFA 2004 (Revision Notes CUF) ', published in the ordinary supplement to the official journal # 259 of November 4, 2004 as amended; View AIFA'S determination of July 3, 2006 published in the official journal-General series-# 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal-General series-# 227, September 29, 2006 concerning "maneuver to the Government subsidized and non-subsidized pharmaceutical shopping»; Visto l'art. 11, paragraph 1, last sentence, of Decree-Law No 158 September 13, 2012, converted, with amendments, by law November 8, 2012, # 189; Visto l'art. 12, paragraphs 5 and 6, of Decree-Law No 158 September 13, 2012, converted, with amendments, by law November 8, 2012, # 189; Given the decree by which the company Mylan S.p.A. It was cleared for placing the medicinal product on PARACALCITOLO MYLAN; Having regard to the application with which the company Mylan S.p.A. has applied for reclassification of the Pack with A.I.C. # 042594034; Having regard to the opinion of the pricing and reimbursement at its meeting of November 5, 2014; Having regard to the resolution of the Board of Directors of November 28, 2014 AIFA 43 adopted on a proposal from the Director General;
Causes: Art. 1 Classification for the purposes of new listings is the medicine PARACALCITOLO MYLAN in the packages below is categorized as follows. Package: «5 micrograms/ml solution for injection 5 ml glass vials from 1 '; A.I.C. # 042594034 (10) 18MVRL (based on 32); new listings: class A; ex factory price (excluding VAT) €46.66; price (VAT included) €87.51. Discount required to public facilities on the price ex factory as per contractual terms. The classification of this determination takes effect, in accordance with art. 11, paragraph 1, last sentence, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, n. 189, the day following the expiration of the patent or supplementary protection certificate, issued by the Ministry of economic development. Until the expiry of the period referred to in the preceding paragraph, the medicine PARACALCITOLO MYLAN is classified, in accordance with art. 12, paragraph 5, of Decree-Law No 158 September 13, 2012, converted, with amendments, by law November 8, 2012, # 189, in the section dedicated to drugs not yet evaluated for the purposes of new listings, the class of article. 8, paragraph 10) (c) of the Act December 24, 1993, no. 537 as amended, called class C (nn).
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