Pharmacovigilance and the italian medicines agency

Journal of Pharmacology and Pharmacotherapeutics

Volumn 4, Issue SUPPL.1, 2013, Pages

  Pimpinella, Giuseppe ^a   Tartaglia, Loriana ^a  

^a ITALIAN MEDICINES AGENCY   (Italy)

Author keywords

AIFA; Italian Medicines Agency; Italian Pharmacovigilance System; pharmacovigilance

Indexed keywords

DRUG INFORMATION; DRUG SURVEILLANCE PROGRAM; DRUG UTILIZATION; EUROPEAN UNION; FUNDING; ITALY; LAW; PRACTICE GUIDELINE; PRESCRIPTION; REVIEW; RISK BENEFIT ANALYSIS; STANDARD;

EID: 84889567710     PISSN: 0976500X     EISSN: None     Source Type: Journal    
DOI: 10.4103/0976-500X.120940     Document Type: Review

References (8)

1. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards Pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products. (Official Journal L 348, 31.12.2010, p. 1-16) Available from: http://www.eur?lex.europa.eu/ LexUriServ/LexUri Serv.do?uri=OJ: L: 2010:348:0001:0016:EN: PDF [Last accessed on 2013 Sep 10].
2. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. (Official Journal L 348, 31/12/2010, p. 74-99). Available from: http://www. eur?lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ: L: 2010:348:0074:00 99:EN: PDF [Last accessed on 2013 Sep 10].
3. Guideline on good pharmacovigilance practices: Module I?Pharmacovigilance systems and their quality systems. EMA. February 2012. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news-and-events/news/2012/02/ news-detail-001451.jsp and mid=WC0b01ac058004d5c1 [Last accessed on 2013 Sep 10].
4. Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council. (Official Journal L 159, 20/06/2012) Available from: http://www. eur?lex.europa.eu/LexUriServ/ LexUriServ.do?uri=OJ: L: 2012:159:0005:0 025:EN: PDF [Last accessed on 2013 Sep 10].
5. Law N. 449 issued on 27/12/1997. Measures for the stabilization of public finance (Official Journal of the Italian Republic 30/12/1997) Available from: http://www.parlamento.it/parlam/leggi/97449l.htm [Last accessed date on 2013 Sep 10].
6. Law N. 296 issued on 27/12/2006. Dispositions for the annual and pluriannual State balance. (Official Journal of the Italian Republic n. 299 27/12/2006). Available from: http://www.parlamento.it/parlam/leggi/06296l.htm [Last accessed date on 2013 Sep 10].
7. Trotta F, Tartaglia L, Alessandro A, Casini ML, Capponi S, Ferrazin F. Italian Medicines Agency (AIFA), Roma, Italy. Programme for funding Active Pharmacovigilance Projects in the Italian Regions. Drug Safety 2012;35.
8. Trotta F, Tartaglia L, Tellone C, Ferrazin F, Santuccio C. Italian Medicines Agency (AIFA), Roma, Italy. Italian Programme for the performance Monitoring of Regional Pharmacovigilance Centres. Drug Safety 2012;35.