Reclassification Of The Medicinal Product For Human Use «Bemfola» (Follitropin Alpha), In Accordance With Article 8, Paragraph 10, Of The Legge24 December 1993, No. 537. (Resolution No. 446/2015).

Original Language Title: Riclassificazione del medicinale per uso umano «Bemfola»(follitropina alfa), ai sensi dell'articolo 8, comma 10, della legge24 dicembre 1993, n. 537. (Determina n. 446/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-07&atto.codiceRedazionale=15A03338&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 "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" with particular reference to art. 8; Visto l'art. 1, paragraph 40, December 23, 1996, law n. 662 on "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 authorisation holders between agency and S. N.; 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; Having regard to the 1 February 2001 CIPE; View the determination October 29, 2004 "Notes 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 No 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal, General series No. 227, September 29, 2006 concerning "maneuver for Government subsidized and non-subsidized pharmaceutical expenditure"; Given the decree by which the company was entitled to FARROW BIOTECH AG marketing of medicine BEMFOLA (Follitropin Alpha); Having regard to determination no. 185/2015 of February 23, 2015, published in the Gazzetta Ufficiale della Repubblica italiana n. 62 of March 16, 2015; Having regard to the application with which the company asked FARROW BIOTECH AG the reclassification of packs with n. 043364037/043364025/E and AIC and; Having regard to the opinion of the scientific and Technical Advisory Committee at its meeting of January 21, 2015; Having regard to the opinion of the Committee at its meeting of March 6, 2015 and reimbursement rates; Having regard to resolution No. 6 on March 25, 2015 AIFA's Board of Directors adopted on the proposal of the Director General;
Causes: Art. 1 Classification for the purposes of new listings is the medicine BEMFOLA (Follitropin alfa) in the packages below is classified as follows: Pack 150 IU/0.25 ml prefilled pen solution for injection-: cartridge (glass type 1), plunger stopper (halobutyl rubber), molded aluminum Cap with rubber lining-1 Pack (prefilled pen + Aug + alcohol wipe) AIC # 043364025/E (10) 19CCPT (based on 32) new listings ' class : A (Note 74) ex factory Price (excluding VAT): €43.24 retail price (VAT included): 0.375 225 IU/ml-€71.36 Packaging solution for injection-pen: cartridge (glass type 1), plunger stopper (halobutyl rubber), molded aluminum Cap with rubber lining-1 Pack (prefilled pen + Aug + alcohol wipe) AIC # 043364037/E (10) 19CCQ5 (based on 32) new listings ' class : A (Note 74) ex factory Price (excluding VAT): €64.05 retail price (VAT included): €105.71 Discount required to public facilities on the price ex factory as per contractual terms. Validity of the contract: 24 months.