Good pharmacovigilance practices

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Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

Guideline on GVP

The guideline on GVP is divided into chapters that fall into two categories:

  • modules covering major pharmacovigilance processes;
  • product- or population-specific considerations.

Each chapter is developed by a team consisting of experts from the European Medicines Agency and from EU Member States.

The guideline on GVP is a key deliverable of the 2010 pharmacovigilance legislation

Modules covering major pharmacovigilance processes

GVP modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is concluded. The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the Agency’s website (see  'Related links' box below Final GVP modules table).

Product- or population-specific considerations

The chapters on product- or population-specific considerations have been developed for vaccines and biological medicinal products. Two more considerations chapters are planned as follows:

Chapter numberChapter titleDate of release for public consultation
P IIIPregnancy and breast-feeding2017
P IVGeriatric population2017

Archives of documents

Table of contents


Introduction

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Final GVP modules

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Document(s) Language Status First published Last updated Effective Date
Guideline on good pharmacovigilance practices: Module I – Pharmacovigilance systems and their quality systems (English only) adopted 2012-06-25   2012-07-02
Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (English only) adopted 2012-06-25 2013-04-12 2013-04-12
Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections (English only) adopted 2012-12-13 2014-09-15 2014-09-16
Guideline on good pharmacovigilance practices (GVP) - Module IV – Pharmacovigilance audits (Rev. 1) (English only) adopted 2015-08-11    
Guideline on good pharmacovigilance practices: Module V – Risk management systems (English only) adopted 2012-06-25 2014-04-25 2014-04-28
Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (English only) adopted 2012-06-25 2014-09-15 2014-09-16
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report (English only) adopted 2012-06-25 2013-12-12 2013-12-13
Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 2) (English only) adopted 2012-06-25 2016-08-08 2016-08-09
Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements and recommendations for the submission of information on non-interventional post-authorisation safety studies (Rev. 2) (English only) adopted 2012-06-25 2016-08-08 2016-08-09
Guideline on good pharmacovigilance practices: Module IX – Signal management (English only) adopted 2012-06-25   2012-07-02
Guideline on good pharmacovigilance practices: Module X – Additional monitoring (English only) adopted 2013-04-25   2013-04-25
Guideline on good pharmacovigilance practices: Module XV – Safety communication (English only) adopted 2013-01-24   2013-01-24
Guideline on good pharmacovigilance practices: Module XVI– Risk minimisation measures - Selection of tools and effectiveness indicators (English only) adopted 2014-02-28 2014-04-25 2014-04-28
Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials (English only) adopted 2015-12-15   2015-12-16

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Final GVP product- or population-specific considerations

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Final GVP annex I - Definitions

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Document(s) Language Status First published Last updated Effective Date
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev 3) (English only) adopted 2012-06-25 2014-04-25 2014-04-28

Final GVP annex II - Templates

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Document(s) Language Status First published Last updated Effective Date
Guideline on good pharmacovigilance practices: Annex II - Templates: Direct healthcare-professional communication (English only) adopted 2013-01-24   2013-01-23
Guideline on good pharmacovigilance practices: Annex II – Templates: Cover page of periodic safety update report (PSUR) (English only) adopted 2012-06-25 2013-04-25 2013-04-25

Related links

For other templates developed outside the GVP process, see:

Final GVP annex III - Other pharmacovigilance guidance

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Document(s) Language Status First published Last updated Effective Date
Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data (English only) adopted 2005-11-13   2006-05-01
Guideline on conduct of pharmacovigilance for medicines used by the paediatric population (English only) adopted 2007-01-25   2007-01-26
Note for guidance: EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (English only) adopted 2004-08-03 2010-10-22 2011-02-07
Overview of comments received on draft note for guidance: EudraVigilance version 7.1 - Processing of safety messages and individual case safety reports (ICSRs) (English only)   2009-11-20    
Draft note for guidance: EudraVigilance Human version 7.1 - Processing of safety messages and individual case safety reports (ICSRs) (English only) draft: consultation closed 2008-01-31    
Guideline on the use of statistical signal-detection methods in the EudraVigilance data-analysis system (English only) adopted 2008-06-26   2008-12-26
Draft guideline on the use of statistical signal-detection methods in the EudraVigilance data-analysis system (English only) draft: consultation closed 2006-11-15    
Overview of comments received on the draft guideline on the use of statistical signal-detection methods in the EudraVigilance data-analysis system (English only)   2008-06-26    
EudraVigilance access policy for medicines for human use (English only) adopted 2011-07-08 2011-08-23 2011-07-08

Final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance

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Document(s) Language Status First published Last updated Effective Date
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 A: Clinical safety data management: Definitions and standards for expedited reporting - Step 5 (English only) adopted 1995-06-01   1995-06-01
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2B (R3): Electronic transmission of individual case safety reports (ICSRs) - data elements and message specification - implementation guide - Step 5 (English only) adopted 2005-09-01 2013-08-27  
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 B (R5): Questions and answers: Data elements for transmission of individual case safety reports - Step 5 (English only) adopted 2005-03-01 2016-07-28 2016-07-28
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2C (R2) on periodic benefit-risk evaluation report - Step 5 (English only) adopted 2012-12-31   2013-01-01
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5 (English only) adopted 2003-11-30   2004-05-01
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5 (English only) adopted 2004-12-31   2005-06-01
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2F on development safety update report - Step 5 (English only) adopted 2010-09-30   2011-09-01

Related links

Final GVP annex V - Abbreviations

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Document(s) Language Status First published Last updated Effective Date
Guideline on good pharmacovigilance practices: Annex V – Abbreviations (English only)   2013-04-25    

Draft GVP chapters and annexes for public consultation

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Privacy statement for public consultation

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Document(s) Language Status First published Last updated Effective Date
Specific privacy statement: Public consultation of good pharmacovigilance practices (English only)   2012-02-22    

Related links