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; Having regard to the December 14, 2000, law # 376 on "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. 5 222/2007 law published in the Official Journal No. 279 of November 30, 2007; Having regard to the Legislative Decree of April 8, 2003, n. 95, on the implementation of Directive 2000/38/EC and introducing a list of medicines to be subjected to intensive monitoring; 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; Having regard to Council Regulation No 726/2004/EC; 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 n. 156 of July 7, 2006; View AIFA determination of September 27, 2006 published in the official journal-General series No 227 of September 29, 2006 concerning "maneuver for Government subsidized and non-subsidized pharmaceutical expenditure"; Given the decree by which the society Accord Healthcare Limited has been cleared for marketing the drug FLUOROURACIL AHCL; Having regard to the notification procedure UK/H/1185/001//II/024 transmitted by the competent authority of the reference Member State (RMS); Viewed handouts annexes forming an integral part of this determination; Having regard to the opinion of the scientific and Technical Advisory Committee at its meeting of April 7, 2014;
Causes: Art. 1 Classification for the purposes of new listings is the new therapeutic indication Fluorouracil is indicated for the treatment of the following malignancies and diseases: in the treatment of metastatic colorectal cancer; in colon and rectal cancer adjuvant treatment; in the treatment of advanced gastric cancer; in the treatment of advanced pancreatic carcinoma; in the treatment of advanced esophageal carcinoma; in the treatment of advanced or metastatic breast cancer; as adjuvant treatment in patients with operable primary invasive breast cancer; in the treatment of unresectable, locally advanced head and neck squamous cell in patients not previously treated; in the treatment of locally recurrent or metastatic squamous cell carcinoma of the head and neck, the medicine Fluorouracil AHCL not reimbursed by the national health service.