Draft guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products

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Document details

Download document Draft guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products
Reference number EMA/873138/2011 Rev 1
Status draft: consultation closed
First published 07/06/2013
Last updated 07/06/2013

Summary

This module addresses the legal requirements detailed in title IX of Directive 2001/83/EC and chapter 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, marketing-authorisation holders and the European Medicines 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.