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; Having regard to article 48, paragraph 33, November 24, 2003, law # 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 in Official Gazette No. 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 1000 FARMA S.R.L. It was cleared for parallel imports of the medicinal product PANTORC; 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 asked 1000 package reclassification Farma S.R.L. with n. A.I.C. 043159033 and 043159045; 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 medicine PANTORC in the packages below and is billed as follows: container: 14 20 mg gastro-resistant tablets blister-A.I.C.: 1953HT 043159033 (10) (32). New listings: class A (Note 1-48). Price ex factory (incl. VAT): €4.28. Retail price (incl. VAT): €7.06. Packaging: 14 40 mg gastro-resistant tablets in blister-A.I.C.: 1953J5 043159045 (10) (32). New listings: class A (Note 1-48). Price ex factory (incl. VAT): €7.14. Retail price (incl. VAT): €11.78.