Reclassification Of The Medicinal Product For Human Use "zoledronicoaccord Acid", In Accordance With Article 8, Paragraph 10, Of The Act December 24, 1993, # 537. (Determines # 229/2015).

Original Language Title: Riclassificazione del medicinale per uso umano «Acido ZoledronicoAccord», ai sensi dell'articolo 8, comma 10, della legge 24 dicembre1993, n. 537. (Determina n. 229/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-18&atto.codiceRedazionale=15A01965&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 the Decree-Law September 13, 2012, # 158, converted, with amendments by law November 8, 2012, n. 189 laying down "urgent provisions to promote the development of the country through a higher level of health protection ' and, in particular, article. 12, paragraph 5; 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 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-# 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»; Given the decree by which the society Accord Healthcare Limited has been authorised the placing on the market of the medicinal product ' zoledronic acid Accord '; Having regard to the determination of the 1 St April # 334/2014 2014, published in the Gazzetta Ufficiale della Repubblica italiana n. 94 of April 23, 2014, on the classification of the medicinal product in accordance with art. 12, paragraph 5, reads November 8, 2012, n. 189 of medicinal products for human use centrally approved; Having regard to the application with which the firm Accord Helathcare Limited has applied for reclassification of A.I.C. code packs # 043198011/E, 043198023 and n. A.I.C. A.I.C. # 043198035 (s); Having regard to the opinion of the scientific and Technical Advisory Committee of January 19, 2015; Having regard to resolution No. 5 of February 18, 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 drug ZOLEDRONIC ACID ACCORD in the packages below is categorized as follows. Package: «4 mg/5 ml-concentrate for solution for infusion-intravenous-vial 4 mg/5 ml (plastic)-1 vial-A.I.C. # 043198011/E (10) 1969KV (based on 32). New listings ': ' H ' class. Ex factory price (excluding VAT): € 47.00. Price (VAT included): € 77.56. Package: «4 mg/5 ml-concentrate for solution for infusion-intravenous-vial (plastic) 4 mg/5 ml-4 vials-A.I.C. # 043198023/E (10) 1969L7 (based on 32). New listings ': ' H ' class. Ex factory price (excluding VAT): £ 187.99. Price (VAT included): € 310.24. Package: «4 mg/5 ml-concentrate for solution for infusion-intravenous-vial (plastic) 4 mg/5 ml-10 vials-A.I.C. # 043198035/E (10) 1969LM (based on 32). New listings ': ' H ' class. Ex factory price (excluding VAT): € 470.00. Price (VAT included): € 775.60.