Request For Presentation Of Variation For Changing Deglistampati Of Herbal Medicines Paroxetina Prac For The Following Dellaraccomandazione Adottatanella 06-09 «Aggression» Signal Sitting January 2015. (Determines Fv # 48/2015) ...

Original Language Title: Richiesta di presentazione di variazione per la modifica deglistampati dei medicinali a base di PAROXETINA a seguito dellaraccomandazione del PRAC relativa al segnale «Aggression» adottatanella seduta del 06-09 gennaio 2015. (Determina FV n. 48/2015)...

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-04&atto.codiceRedazionale=15A01491&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The DIRECTOR of the Office of farmacovigilianza 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 supplements, in particular art. 38; Visto l'art. 80, paragraphs 1 and 3, of Legislative Decree No 219, April 24, 2006 and subsequent modifications and additions concerning the bilingual drafting of labels and package leaflets of medicines; Having regard to Council Regulation (EC) No 1234/2008 as amended by Regulation (EC) No 712/2012 of August 3, 2012 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products; Having regard to the determination of the Director-General of AIFA on "criteria for the application of the provisions on the disposal of stocks of medicinal products ' # 371 of April 14, 2014, adopted, pursuant to art. 37 of legislative decree 219/2006 and subsequent modifications and integrations, as amended by art. 44, paragraph 4-quinquies of Decree-Law No 69 June 21, 2013, bearing: "urgent measures for economic recovery", converted, with amendments, into law No 98 August 9, 2013, published in the official journal-General series-# 101 of May 3, 2014, effective as from June 3, 2014; Given the need for updating and harmonisation of information handouts of herbal medicinal products of the active substance paroxetina following the recommendation of PRAC for the signal ' Aggression ' adopted at the sitting of 6-9 January 2015; Felt, to protect public health, mentoring to change handouts of medicines containing the above mentioned active substances;
Causes: Art. 1 1. It is compulsory to all holders of authorisation for medicinal products containing the active ingredient paroxetine authorised mutual recognition/decentralised national or with Italy as a reference state (RMS), to submit, no later than March 29, 2015, the AIFA-Office evaluation and authorisation, an application for variation in accordance with Council regulation 1234/2008/CE and subsequent modifications and integrations in order to implement the changes to the summary of product characteristics and the package leaflet as indicated in the recommendation of PRAC. Amendments to be made to the summary of product characteristics and the package leaflet are available at the following address: http://www.ema.europa.eu/docs/en_GB/document_library/PRAC_recommendat ion_on_signal/01/2015/EMA WC500181043.pdf. 2. Marketing Authorisation holders to parallel imports of medicines for systemic use containing the active ingredient mentioned in art. 1, paragraph 1, are required to comply with what is indicated, not later than thirty days after the result of the adaptation of printed Italian A.I.C. holder.