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. 4 August 2016 EMA/168402/2014 Corr* Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations II: Biological medicinal products Draft finalised by the Agency in collaboration with Member States 17 November 2015 Draft agreed by the European Risk Management Strategy Facilitation Group (ERMS FG) 24 November 2015 Draft adopted by Executive Director 8 December 2015 Start of public consultation 15 December 2015 End of consultation (deadline for comments) 29 February 2016 Revised draft finalised by the Agency in collaboration with Member States 9 June 2016 Revised draft agreed by ERMS FG 26 July 2016 Revised draft adopted by Executive Director as final 4 August 2016 Date for coming into effect 16 August 2016 * The correction replaces Module by Considerations Chapter or Chapter where appropriate in and updates references to GVP to harmonise the style.

Pharmacovigilance Practices (GVP) Introductory Cover Note5 and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”. References to the legislation are provided as follows: Directive 2001/83/EC as amended is referenced

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