Pharmacovigilance: Regulatory and procedural guidance

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The European Medicines Agency developed the good-pharmacovigilance-practice (GVP) guideline to facilitate the performance of pharmacovigilance activities in the European Union. GVP is a key deliverable of the 2010 pharmacovigilance legislation to replace earlier guidance drawn up by the European Commission.

Until July 2012,  the European Commission drew up pharmacovigilance guidelines in accordance with Article 106 of Directive 2001/83/EC of the European Parliament and the Council, known as volume 9A. With the application of the new pharmacovigilance legislation as of July 2012, volume 9A has now been replaced by the good-pharmacovigilance-practice (GVP) guideline, published by the Agency. Where GVP modules have not yet been finalised, and for some transitional measures, the relevant parts of volume 9A of the rules governing medicinal products in the European Union remain applicable.

For more information on transitional measures, see questions and answers on implementation of pharmacovigilance legislation.

Other guidelines not incorporated in the GVP guideline, as well as current and historical concept papers and draft guidelines under public consultation, are listed below.

Guidance is also available on withdrawn products notification and risk-management plans.

Table of contents


Guidance for marketing-authorisation holders

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Pharmacovigilance practices

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Document(s) Language Status First published Last updated Effective Date
Reflection paper on collecting and reporting information on off-label use in pharmacovigilance (English only) draft: consultation closed 2016-04-29    
Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (English only) adopted 2015-05-12    
Overview of comments received on 'Detailed Guide regarding the Monitoring of Medical Literature and the Entry of Relevant Information into the EudraVigilance Database by the European Medicines Agency on Literature Monitoring (English only)   2015-05-12    
Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (English only) draft: consultation closed 2014-06-05    
List of active substances subject to worksharing for signal management (English only)   2012-10-05 2016-08-03  
CHMP guideline on detection and management of duplicate individual cases and individual case safety reports (English only) adopted 2012-06-21   2012-07-02
Draft guideline on detection and management of duplicate individual cases and individual case safety reports (English only) draft: consultation closed 2010-06-29    
EudraLex – Volume 9A – Questions and answers on implementation - Version 5.4 (English only) adopted 2011-03-29    
EudraVigilance Expert Working Group: Volume 9A implementation questions and answers - Version 3.2 (English only) adopted 2008-10-21    
EudraVigilance Expert Working Group: Volume 9A implementation questions and answers - Version 1.2 (English only) adopted 2008-02-28    
Implementation plan for the 'Note for guidance - EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)' (English only) adopted 2009-11-20 2010-10-22