Pharmacovigilance: Regulatory and procedural guidance
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 With the application of the new pharmacovigilance legislation as of July 2012, volume 9A has now been replaced by the good-pharmacovigilance-practice (GVP) guideline, published by the Agency.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Guidance is also available on withdrawn products notification and risk-management plans.
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Questions and answers on variations to an existing pharmacovigilance system as described in the detailed description of the pharmacovigilance system (PDF/75.05 KB)
Adopted
First published: 02/03/2011
Last updated: 02/08/2013
EMA/456003/2013 -
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Reporting requirements of individual case safety reports applicable to marketing-authorisation holders during the interim period (PDF/100.32 KB)
First published: 23/05/2012
Last updated: 30/06/2015
EMA/321386/2012 Rev. 9 -
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European Union individual case safety report (ICSR) implementation guide (PDF/1.5 MB)
Adopted
First published: 30/04/2014
Last updated: 07/04/2021
Consultation dates: 30/04/2014 to 30/06/2014
EMA/51938/2013 Rev. 2 -
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Questions and answers on signal management (PDF/336.17 KB)
First published: 04/10/2013
Last updated: 15/01/2021
EMA/261758/2013 Rev 4*
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Reflection paper on collecting and reporting information on off-label use in pharmacovigilance (PDF/142.51 KB)
Draft: consultation closed
First published: 29/04/2016
Last updated: 29/04/2016
Consultation dates: 29/04/2016 to 29/07/2016
EMA/293194/2016 -
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Detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (PDF/279.97 KB)
Adopted
First published: 12/05/2015
Last updated: 12/05/2015
EMA/161530/2014 -
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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 Monito... (PDF/338.71 KB)
First published: 12/05/2015
Last updated: 12/05/2015
EMA/716877/2014 -
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Draft detailed guide regarding the monitoring of medical literature and the entry of relevant information into the EudraVigilance database by the European Medicines Agency (PDF/149.2 KB)
Draft: consultation closed
First published: 05/06/2014
Last updated: 05/06/2014
Consultation dates: 05/06/2014 to 27/07/2014
EMA/161530/2014 -
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List of substances and products subject to worksharing for signal management (XLSX/145.78 KB)
First published: 05/10/2012
Last updated: 20/07/2022
EMA/563056/2014 Rev. 11 -
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CHMP guideline on detection and management of duplicate individual cases and individual case safety reports (PDF/254.02 KB)
Adopted
First published: 21/06/2012
Last updated: 21/06/2012
Legal effective date: 02/07/2012
EMA/13432/2009 -
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Draft guideline on detection and management of duplicate individual cases and individual case safety reports (PDF/181.18 KB)
Draft: consultation closed
First published: 29/06/2010
Last updated: 29/06/2010
Consultation dates: 29/06/2010 to 29/09/2010
EMA/13432/2009 -
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EudraLex – Volume 9A – Questions and answers on implementation - Version 5.4 (PDF/483.59 KB)
Adopted
First published: 29/03/2011
Last updated: 29/03/2011
EMA/46003/2011 -
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EudraVigilance Expert Working Group: Volume 9A implementation questions and answers - Version 3.2 (PDF/558.24 KB)
Adopted
First published: 21/10/2008
Last updated: 21/10/2008
EMEA/560457/2008 -
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EudraVigilance Expert Working Group: Volume 9A implementation questions and answers - Version 1.2 (PDF/451.9 KB)
Adopted
First published: 29/02/2008
Last updated: 29/02/2008
EMEA/111972/2008 -
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Implementation plan for the 'Note for guidance - EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs)' (PDF/161.4 KB)
Adopted
First published: 20/11/2009
Last updated: 22/10/2010
EMEA/665231/2008 Rev. 1