Guideline on good pharmacovigilance practices (GVP)

See websites for contact details European Medicines Agency Heads of Medicines Agencies The European Medicines Agency is an agency of the European Union European Medicines Agency and Heads of Medicines Agencies, 2017. Reproduction is authorised provided the source is acknowledged. 9 October 2017 EMA/813938/2011 Rev 3* Guideline on good pharmacovigilance practices (GVP) Module VIII Post-authorisation safety studies (Rev 3) Date for coming into effect of first version 2 July 2012 Date for coming into effect of Revision 1 25 April 2013 Date for coming into effect of Revision 2 9 August 2016 Revised draft Revision 3* finalised by the Agency in collaboration with Member States 27 September 2017 Revised draft Revision 3 agreed by the EU Network pharmacovigilance Oversight Group (EU-POG) 4 October 2017 Revised draft Revision 3 adopted by Executive Director as final 9 October 2017 Date for coming into effect of Revision 3* 13 October 2017 *Note: Revision 3 contains the following: - Updates in (study protocol section 11), and (final study report section ), in order to align this Module with revision 2 of GVP Module VI.

Non-interventional studies are defined by the methodological approach used and not by its scientific objectives. Non-interventional studies include database research or review of records where all the events of interest have already happened (this may include case- control, cross-sectional, cohort or

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  Guidelines, Good, Practices, Guideline on good pharmacovigilance practices, Pharmacovigilance, Interventional

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