Deleting From The List Of Medicinal Products For Human Use The Cuiautorizzazione Authorisation Is Cancelled To The Meaning Of Art. 38 Of Legislative Decree No 219, April 24, 2006 And Subsequent Modifications And Integrations, Drugs: Anv.

Original Language Title: Eliminazione dall'elenco dei medicinali per uso umano la cuiautorizzazione all'immissione in commercio risulta decaduta ai sensidell'art. 38 del decreto legislativo 24 aprile 2006, n. 219, esuccessive modificazioni ed integrazioni, dei medicinali: Anv...

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The MANAGER of the Office evaluation and authorisation Saw art. 48 d.l. September 30, 2003 # 269 converted into law no 326 November 24, 2003, establishing the Italian medicines agency; Having regard to the September 20, 2004 Decree n. 245 of the Minister of health, in consultation with the Ministers of economy and finance and civil service: "regulation laying down rules on the organisation and the functioning of the Italian Medicines Agency, in accordance with art. 48, paragraph 13 of the Decree-Law No 269 September 30, 2003, converted, with amendments, by law November 24, 2003, # 326 "March 29, 2012, as modified by Decree No. 53 of the Minister of health, in consultation with the Ministers for public administration and simplification and of economy and finance:" amendments to the regulation and functioning of Agenzia italiana del farmaco (AIFA) , pursuant to art. 17, paragraph 10, of the Decree-Law July 6, 2011, n. 98, converted, with amendments, by law No 111 July 15, 2011 "; Having regard to regulation for the organisation, administration and the organisation of the Italian medicines agency staff published in the Gazzetta Ufficiale-serie generale n. 254 of 10/31/2009; Having regard to the Legislative Decree March 30, 2001, # 165 on "general rules on labour sort employed by public administrations" and s; Having regard to act July 15, 2002, # 145, containing "Provisions for the reorganization of the State leadership and to foster the exchange of experiences and the interaction between the public and private sectors"; View the determination # 1237 of October 30, 2014, with which the Director-General of the Italian Medicines Agency gave the dott.ssa Anna Rosa Marra registration Area Coordinator and the Director of the Office of evaluation and authorisation; Visto l'art. April 24, 2009, 38 of Legislative Decree n. s 219 and on "implementation of Directive 2001/83/EC (and subsequent amending directives) on the Community code relating to medicinal products for human use, as well as of Directive 2003/94/EC", and s; See paragraph 5 of art. 38 above, which States that the data concerning the placing on the market (AIC) lapsed shall be published in the official journal of the Italian Republic by the Agenzia italiana del farmaco (AIFA); Having regard to the guidelines Sunset Clause-legal framework "published in the internet portal of the AIFA registration section/Sunset Clause; Whereas the mahs are required to transmit data to marketing its medicinal products within the meaning of the Ministerial Decree of July 15, 2004 published in the Gazzetta Ufficiale della Repubblica italiana n. 2 of January 4, 2005 on "Establishment at the Italian medicines agency, of a central database designed to track packages of medicinal products within the distribution system" and d. Lgs. 219/06, art. 130, paragraph 11, as amended by Decree-Law No 158 signed into law November 8, 2012 September 13, 2012, n. 10, paragraph 1, article 189 c), published in the Official Gazette # 158 of 9/13/2012 concerning "Conversione in legge, con modificazioni, del decreto-legge September 13, 2012, # 158, bearing urgent provisions to promote the development of the country through a higher level of health protection"; View the determination # 2571 of December 4, 2014, published in the Gazzetta Ufficiale della Repubblica italiana n. 301 of December 30, 2014, concerning the list of medicinal products for which marketing authorisation is cancelled pursuant to art. April 24, 2006, 38 of Legislative Decree n. 219, and subsequent amendments and additions, which included medicines ANVAR (AIC # 040966) FLUCONAZOLE EUROGENERICI (AIC # 040228) IASAR (AIC # 038872); Taking into account that the holder of the MARKETING AUTHORISATION, in the note received by the AIFA on January 19, 2015-prot. # 5145 del 1/20/2015, said they had sent to drug tracking system of the Ministry of health data for the marketing of medicines Anvar (AIC # 040966) Fluconazole Eurogenerici (AIC # 040228) Iasar (AIC # 038872) incorrectly and I proceeded to request the opening of the flow of exceptions at the same Ministry; Given that medicines agency Anvar (AIC # 040966) Fluconazole Eurogenerici (AIC # 040228 Iasar (ICA) n. 038872) it's been passed, although subsequent to the date of December 30, 2014, with the same note above, the Office of evaluation and authorisation of AIFA, copy of proper documentation that proves the marketing before the date of the alleged decadence; Considered, therefore, not applicable to medicines Anvar (AIC # 040966) Fluconazole Eurogenerici (AIC # 040228) Iasar (AIC # 038872) art. 38, paragraphs 5 and 7 of the d. lgs. 219/06 and s; Deemed necessary, then, in accordance with and for the purposes of Law 241/1990 s, and art. 21-h, excluding medicines Anvar (AIC # 040966) Fluconazole Eurogenerici (AIC # 040228) Iasar (AIC # 038872) from the list of medicinal products expired for failure to commercialization (annexed to determination no. 2571 of December 4, 2014, published in the Gazzetta Ufficiale della Repubblica italiana no 301 of December 30, 2014);
Causes: Art. 1 1. It is partially cancelled, for all legal purposes, determining # 2571 of December 4, 2014, published in the Gazzetta Ufficiale della Repubblica italiana no 301 of December 30, 2014 in so far as, in the annex on medicinal products are entered Anvar (AIC # 040966) Fluconazole Eurogenerici (AIC # 040228) Iasar (AIC # 038872)