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EU: EMA Published Revised GVP Module on Suspected Adverse Reactions

Wednesday, August 02, 2017: The European Medicines Agency (EMA) has published the second revision of the guideline on good pharmacovigilance practices (GVP) Module VI (collection, management and submission of reports of suspected adverse reactions to medicinal products).

This Module of GVP addresses the legal requirements detailed in Directive 2001/83/EC [DIR] and Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency, as regards the collection, data management and submission of individual reports of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU).

It is published as final, with amendments in the light of the public consultation. Its Addendum on the duplicate management of suspected adverse reaction reports is also published as new guidance in GVP, based on a previous guideline published before GVP came into existence. Both Module VI and its Addendum will come into effect on 22 November 2017, together with the new EudraVigilance functionalities and application of the ICH-E2B(R3) guideline. Further, a public consultation until 13 October 2017 is launched for new Product- or Population-Specific Considerations, namely on the paediatric population. These Considerations have been based on a guideline published before GVP came into existence and are now the first GVP guidelines focussing on a specific population group.

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