Reclassification Of The Medicinal Product For Human Use "the Meaning Of Article 8 Bydureon, Paragraph 10, Of The Act December 24, 1993, # 537. (Resolution No. 291/2015).

Original Language Title: Riclassificazione del medicinale per uso umano «Bydureon», ai sensidell'articolo 8, comma 10, della legge 24 dicembre 1993, n. 537.(Determina n. 291/2015).

Read the untranslated law here:

The DIRECTOR-GENERAL having regard to articles 8 and 9 of legislative decree July 30, 1999, # 300; Visto l'art. 48 of Decree-Law No 269 September 30, 2003, 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; Having regard to the December 14, 2000, law # 376 laying "discipline of health sports and activities in the fight against doping '; 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.; Visto l'art. 5 of law No 222/2007 published in the Official Journal No. 279 of November 30, 2007; 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 company Astrazeneca AB has been cleared for placing the medicinal product on BYDUREON; Having regard to the determination of 54/2015 26/01/2015, n. pubblicata nella Gazzetta Ufficiale della Repubblica Italiana n. 41 of 19/02/2015 concerning the classification of the medicinal product in accordance with art. 12, paragraph 5, reads November 8, 2012 # 189 of medicinal products for human use centrally approved; Having regard to the application with which the firm Astrazeneca AB has applied for reclassification of the Pack code A.I.C. # 041276039 (s); Having regard to the opinion of the scientific and Technical Advisory Committee of the 19/01/2015; Having regard to resolution No. 5 dated 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 medicine BYDUREON in Pack below is classified as follows: pack size: 2 mg powder and solvent for suspension for injection in prefilled pen-sustained-release subcutaneous-prefilled pen (glass) 2 mg in 1 ml single dose prefilled pens-0.65 4 reserve injection needle-A.I.C. n. 041276039/E (10) 17CNN7 (based on 32). New listings ' class: a. price ex factory (incl. VAT): €99.68. Retail price (incl. VAT): €164.52. Validity of the contract: 24 months. Negotiating conditions remain in force.