Reclassification Of The Medicinal Product For Human Use "article 8, Comma Cardura ' Within The Meaning Of The Law 10 December 24, 1993, # 537. (Resolution No. 435/2015).

Original Language Title: Riclassificazione del medicinale per uso umano «Cardura» ai sensidell'articolo 8, comma 10, della legge 24 dicembre 1993, n. 537.(Determina n. 435/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-05-06&atto.codiceRedazionale=15A03287&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 action 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 "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 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 to the Government subsidized and non-subsidized pharmaceutical shopping»; Given the decree by which the Corporation was authorized Four Pharma Clinical Research Organization to parallel imports of the medicinal product CARDURA; Having regard to the determination of classification in band C (nn) pursuant to art. 12, paragraph 5, of Decree-Law No September 13, 2012. 158, converted, with amendments, by law November 8, 2012, # 189; Having regard to the application with which the company Four Pharma Clinical Research Organization requested the reclassification of the packs with # 043513011 and 043513023 MA; Having regard to the opinion of the scientific and Technical Advisory Committee of February 16, 2015; Having regard to resolution No. 6 of 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 CARDURA in the packages below is classified as follows: «4 mg tablets» 20 tablets-AIC # 043513011 (10) 19HX5M (based on 32) new listings ' class ' A ' ex factory Price (excluding VAT) € 5.70 retail price (VAT included) € 9.40 Pack «2 mg tablets 30 tablets-AIC ' n. 043513023 (10) 19HX5Z (based on 32). New listings ' class «A» €6.33 ex factory Price (excluding VAT) retail price (tax included) €10.45.