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Anything new in EU pharmacovigilance?

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References

  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

    Article  PubMed  CAS  Google Scholar 

  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

    Article  Google Scholar 

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Acknowledgements

We thank Judith Baggott for editing.

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The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Drug Regulatory Policies Laboratory, “Mario Negri” Institute for Pharmacological Research, via Giuseppe La Masa 19, Milan, 20156, Italy

    Silvio Garattini & Vittorio Bertele’

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  1. Silvio Garattini
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  2. Vittorio Bertele’
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Correspondence to Vittorio Bertele’.

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Garattini, S., Bertele’, V. Anything new in EU pharmacovigilance?. Eur J Clin Pharmacol 67, 1199–1200 (2011). https://doi.org/10.1007/s00228-011-1052-1

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  • DOI: https://doi.org/10.1007/s00228-011-1052-1

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