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.

Most modules are available in their final versions. The full set of modules is scheduled to be available during 2013.

The remaining modules below are under development and are scheduled for release for an eight-week public consultation as indicated below:  

Module numberModule titleDate of release for public consultation
XIPublic participation in pharmacovigilance
Fourth quarter 2014 / first quarter 2015
XIIContinuous pharmacovigilance, ongoing benefit-risk evaluation, regulatory action and planning of public communicationFourth quarter 2014
XIVInternational cooperationFirst/second quarter 2015

Module XIII on incident management is no longer under development. All topics originally intended to be covered in this module are now to be included in module XII.

Product- or population-specific considerations

The chapters on product- or population-specific considerations are currently under development. They are being released for public consultation one by one. The first GVP considerations chapter was published in December 2013, i.e. GVP P I on pharmacovigilance for vaccines for prophylaxis against infectious diseases.

Currently, the following is under development and scheduled for release for an eight-week public consultation as indicated below:

Chapter numberChapter titleDate of release for public consultation
P IIBiological medicinal productsFourth quarter 2014 / first quarter 2015

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 25/06/2012   02/07/2012
Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (English only) adopted 25/06/2012 12/04/2013 12/04/2013
Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections (English only) adopted 13/12/2012 15/09/2014 16/09/2014
Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits (English only) adopted 13/12/2012   13/12/2012
Guideline on good pharmacovigilance practices: Module V – Risk management systems (English only) adopted 25/06/2012 25/04/2014 28/04/2014
Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (English only) adopted 25/06/2012 15/09/2014 16/09/2014
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report (English only) adopted 25/06/2012 12/12/2013 13/12/2013
Guideline on good pharmacovigilance practices: Module VIII – Post-authorisation safety studies (English only) adopted 25/06/2012 25/04/2013 25/04/2013
Guideline on good pharmacovigilance practices: Module VIII addendum I – Member States' requirements for transmission of information on non-interventional post-authorisation safety studies (English only) adopted 25/06/2012 25/04/2013 25/04/2013
Guideline on good pharmacovigilance practices: Module IX – Signal management (English only) adopted 25/06/2012   02/07/2012
Guideline on good pharmacovigilance practices: Module X – Additional monitoring (English only) adopted 25/04/2013   25/04/2013
Guideline on good pharmacovigilance practices: Module XV – Safety communication (English only) adopted 24/01/2013   24/01/2013
Guideline on good pharmacovigilance practices: Module XVI– Risk minimisation measures - Selection of tools and effectiveness indicators (English only) adopted 28/02/2014 25/04/2014 28/04/2014

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Module XIII on incident management is no longer under development. All topics originally intended to be covered in this module are now to be included in module XII.

Where GVP modules refer to the European Medicines Agency's and the Heads of Medicines Agencies' procedural advice on referral procedures for safety reasons, consult:

Final GVP product- or population-specific considerations

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Document(s) Language Status First published Last updated Effective Date
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases (English only) adopted 12/12/2013   13/12/2013

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 25/06/2012 25/04/2014 28/04/2014

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 24/01/2013   23/01/2013
Guideline on good pharmacovigilance practices: Annex II – Templates: Cover page of periodic safety update report (PSUR) (English only) adopted 25/06/2012 25/04/2013 25/04/2013

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

Related links

These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP.

For other pharmacovigilance guidance developed outside the GVP process, see:

Also, note the Rules of Procedure of the Pharmacovigilance Risk Assessment Committee (PRAC)

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 01/06/1995   01/06/1995
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 01/09/2005 27/08/2013  
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 01/03/2005   01/03/2005
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 31/12/2012   01/01/2013
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 30/11/2003   01/05/2004
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 31/12/2004   01/06/2005
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 30/09/2010   01/09/2011

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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)   25/04/2013    

Draft GVP chapters and annexes for public consultation

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There are currently no documents published in this section

Templates for submission of comments

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There are currently no documents published in this section

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)   22/02/2012    

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