Medicinal Products For Which Marketing Authorisation Is Cancelled As A Result Of Non-Renewal By The Holders Of Marketing Authorisations Article 38 Of Legislative Decree No April 24, 2006 219E Subsequent Modifications And Integrations. (De ...

Original Language Title: Medicinali la cui autorizzazione all'immissione in commercio e'decaduta a seguito del mancato rinnovo da parte dei titolari AIC, aisensi dell'articolo 38 del decreto legislativo 24 aprile 2006, n. 219e successive modificazioni ed integrazioni. (Determi...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-26&atto.codiceRedazionale=15A02235&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The MANAGER of the pharmacovigilance Department having regard to articles 8 and 9 of legislative decree July 30, 1999, # 300, bearing the "reform of the Government, in accordance with art. 11 March 15, 1997, law n. 59 '; 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 Decree No 245 of September 20, 2004 of the Minister of health in consultation with the Ministers for the civil service and of economy and finance, as amended by Decree No. 53 of March 29, 2012 of the Ministry of health jointly with the Ministers for public administration and simplification of economy and finance and laying down the rules of organisation and operation of the Italian Medicines Agency, issued pursuant to paragraph 13 of article. 48 above; Having regard to regulation for the organisation, administration and the organisation of the Italian medicines agency staff whose notice was published in the Gazzetta Ufficiale-serie generale-# 22 of January 28, 2015; Having regard to the Legislative Decree March 30, 2001, # 165, laying down general rules on the sort of labour employed by public administrations "and subsequent amendments and integrations; Having regard to law no 145 July 15, 2002 laying down ' provisions for the reorganization of the State leadership and to foster the exchange of experiences and the interaction between the public and private sectors "; 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; View AIFA determination # 521 of May 31, 2013, with which it was awarded to Dr. Joseph Pimpinella over the Office, since 1 June 2013; Having regard to the Legislative Decree of April 24, 2006, n. 219 laying «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 subsequent amendments and integrations; Considering that, by virtue of art. 38 of Legislative Decree No 219/2006 and subsequent modifications and integrations, A.I.C. holders are obliged to firms to apply for renewal, that non-renewal entails authorisation to lapse on expiry of the five-year period and that in cases where the request for renewal is submitted, communication urges the AIFA gives holders of A.I.C. and announces that the medicinal product cannot be marketed; Given that the companies are holders of A.I.C., referred to in the annex to this determination, did not submit an application for renewal for medicinal products referred to in that list, giving explicit communication; Given that the companies are holders of A.I.C. some of the medicinal products listed in the annex to this determination, have submitted an application for renewal in which they talked about not having more interest in the marketing of certain packages, sacrificing for these renewal; Considered it necessary to establish a deadline for withdrawal from the market of stocks already produced, in order to prevent any possible risk to public health arising from the maintenance for medicinal products now free of A.I.C. and, accordingly, taken from the obligations and responsibilities that the legislation provides for the responsibility of the holder;
Causes: Art. 1 1. For the considerations mentioned in the introduction, the marketing authorisations of medicinal products listed in the annex which is an integral part of this determination, I lapsed for non-renewal. 2. The packaging already produced cannot be dispensed to the public as from 180 day following the date of publication of this determination in the official journal of the Italian Republic. Therefore, before the deadline stated above, these packages will be withdrawn from the market. 3. this determination is published in the official journal of the Italian Republic.
Roma, March 9, 2015 the Manager: Pimpinella