Anything new in EU pharmacovigilance?

Author:

Garattini Silvio,Bertele’ Vittorio

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,General Medicine

Reference4 articles.

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 authorisation 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. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF

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. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF

3. Frau S, Font Pous M, Luppino MR, Conforti A (2010) Risk management plans: are they a tool for improving drug safety? Eur J Clin Pharmacol 66:785–790. doi: 10.1007/s00228-010-0848-8

4. Garattini S, Bertele' V (2010) Rosiglitazone and the need for a new drug safety agency. Br Med J 341:c5506. doi: 10.1136/bmj.c5506

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