Draft guideline on good pharmacovigilance practices (GVP) – Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2)schmerzen-11

This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter 3 of Title II of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU). Recommendations regarding the reporting of emerging safety issues or of suspected adverse reactions occurring in special situations are also presented in this Module.

First published 08/08/2016
Last updated 08/08/2016
Consultation start date 08/08/2016
Consultation end date 14/10/2016
Email address for submissions gvp@ema.europa.eu

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