Reclassification Of The Medicinal Product For Human Use «Keneil ' Within The Meaning Of Art. 8, Paragraph 10, Of The Act December 24, 1993, # 537. (Resolution No. 360/2015).

Original Language Title: Riclassificazione del medicinale per uso umano «Keneil» ai sensidell'art. 8, comma 10, della legge 24 dicembre 1993, n. 537.(Determina n. 360/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-04-16&atto.codiceRedazionale=15A02774&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 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 the national health service between agency and marketing authorisation holders; 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»; View AIFA determination # 948 of June 10, 2013, with whom the company was entitled to S.P.A. EG placing the medicine KENEIL; Having regard to the ruling of the TAR of Lazio, section III C # 1415 of February 5, 2014, with which the above determination n. 948/2013 has been partially cancelled, together with acts and opinions assumptions; Having regard to the ruling of the TAR of Lazio, section III C, # 8996/2014, which upheld the appeal in accordance with; Having regard to the opinion of the scientific and Technical Advisory Committee, made at its meeting on 21-23 October 2014, which confirmed the classification of the drug KENEIL in band C; Having regard to the judgment of the State Council # 6346 of December 22, 2014, which confirmed on appeal the judgment of TAR Lazio no 1415/2014; Having regard to the opinion of the scientific and Technical Advisory Committee, made at its meeting of February 2015, 16-18 that, in reform of the A. I.c., approved changes to the drug leaflet KENEIL and limitations of use only in maintenance therapy, which make the availability of medication is not beneficial to the national health service, arranging the classification into Band C/RR, also because of the presence of numerous alternatives already on the market that better covers the multiple regimens required for proper use of medication; Viewed handouts annexes forming an integral part of this determination;
Causes: Art. 1 Classification for the purposes of new listings is the medicine KENEIL in packages below is classified as follows: packaging: «600 mg film-coated tablets» 30 scored tablets-A.I.C. # 039037015 (10) 157B2R (32)-new listings ' class C; «600 mg film-coated tablets» 50 scored tablets-A.I.C. # 039037027 (10) 157B33 (32)-new listings ' class C; «600 mg film-coated tablets» 60 scored tablets-A.I.C. # 039037039 (10) 157B3H (32)-new listings ' class C; «30 film-coated tablets 800 mg scored tablets-039037041» # A.I.C. (10) 157B3K (32)-new listings ' class C; «800 mg film-coated tablets» 50 scored tablets-A.I.C. # 039037054 (10) 157B3Y (32)-new listings ' class C; «800 mg film-coated tablets» 60 scored tablets-A.I.C. # 039037066 (10) 157B4B (32)-new listings ' class C.