Archive of development of good pharmacovigilance practices

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This page lists the documents available during the development of the guideline on good pharmacovigilance practices (GVP).

Table of contents


Introductory cover notes

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Document(s) Language Status First published Last updated Effective Date
Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with draft revision 2 of module VI on management and reporting of adverse reactions and draft revision 1 of module IX on signal management with its addendum for public consultation, and final revision 2 of module VIII on post-authorisation studies with its addendum (English only)   2016-08-08    
Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with draft revision 2 of module V on risk management system for public consultation. (English only)   2016-02-29    
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final addendum I to module XVI on educational materials and, for public consultation draft revision 1 of module XV on safety communication with its templates and draft considerations P.II on biologicals, and information on the revised GVP structure (English only)   2015-12-15    
Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with revision 1 of module IV on audits and launch of public consultation of module VIII and its addendum I on post-authorisation safety studies (English only)   2015-08-11    
Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with launch of public consultation of addendum I to module XVI on educational materials (English only)   2015-04-27    
Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with revision 1 of module III on pharmacovigilance inspections and of module VI on the management and reporting of adverse reactions reports (English only)   2014-09-15    
Guideline on good pharmacovigilance practices: Introductory cover note, last updated with revision 1 of module V on risk management system and subsequent revision 3 of the definitions annex and revision 1 of module XVI on risk minimisation measures (English only)   2014-04-25    
Guideline on good pharmacovigilance practices: Introductory cover note, last updated with final new module on risk minimisation measures (English only)   2014-02-28    
Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with final definition annex revision 2 (English only)   2014-01-08    
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final module VII revision 1 on PSURs and considerations I on vaccines (English only)   2013-12-12    
Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with launch of public consultation of module VI revision 1 and module XVI (English only)   2013-06-07    
Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with launch of public consultation of module VII revision 1, final module X and revision of module VIII, new annexes and final GVP webpage structure (English only)   2013-04-25    
Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with revision of module II, launch of public consultation of P.I and information on GVP maintenance and further development (English only)   2013-04-12    
Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with finalisation of module XV (English only)   2013-01-23    
Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with finalisation of modules III and IV (English only)   2012-12-13    
Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with public consultation launch of draft modules IV and XV (English only)   2012-07-26    
Guidelines on good pharmacovigilance practices: Introductory cover note to finalisation of the first seven modules and public consultation of draft modules III and X (English only)   2012-06-25    
Guidelines on good pharmacovigilance practices: Introductory cover note to the public consultation of the first seven modules (English only)   2012-02-22    

Draft GVP chapters and annexes for closed public consultations

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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) draft: consultation closed 2012-02-22    
Guideline on good pharmacovigilance practices: Module II - Pharmacovigilance system master file (English only) draft: consultation closed 2012-02-22    
Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections (English only) draft: consultation closed 2012-06-27    
Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits (English only) draft: consultation closed 2012-07-26    
Guideline on good pharmacovigilance practices: Module V - Risk management systems (English only) draft: consultation closed 2012-02-22    
Guideline on good pharmacovigilance practices: Module VI - Management and reporting of adverse reactions to medicinal products (English only) draft: consultation closed 2012-02-22    
Draft guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1) (English only) draft: consultation closed 2013-06-07    
Guideline on good pharmacovigilance practices: Module VII - Periodic safety update report (English only) draft: consultation closed 2012-02-22    
Guideline on good pharmacovigilance practices: Module VII – Periodic safety update report (Rev 1) (English only) draft: consultation closed 2013-04-25    
Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 2) (English only) draft: consultation closed 2015-08-11    
Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 2) (English only) draft: consultation closed 2015-08-11    
Guideline on good pharmacovigilance practices: Module VIII - Post-authorisation safety studies (English only) draft: consultation closed 2012-02-22    
Guideline on good pharmacovigilance practices: Module IX - Signal management (English only) draft: consultation closed 2012-02-22    
Guideline on good pharmacovigilance practices: Module X – Additional monitoring (English only) draft: consultation closed 2012-06-27    
Guideline on good pharmacovigilance practices: Module XV – Safety communication (English only) draft: consultation closed 2012-07-26    
Guideline on good pharmacovigilance practices: Module XVI – Risk-minimisation measures: selection of tools and effectiveness indicators (English only) draft: consultation closed 2013-06-07    
Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials (English only) draft: consultation closed 2015-04-27    
Guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases (English only) draft: consultation closed 2013-04-12    
Guideline on good pharmacovigilance practices: Annex I - Definitions (English only) draft: consultation closed 2012-02-22    
Guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I (English only) draft: consultation closed 2013-04-12    
Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations II: biological medicinal products (English only) draft: consultation closed 2015-12-15    

Comments received during public consultation

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Document(s) Language Status First published Last updated Effective Date
General comments received from public consultation on good pharmacovigilance practices (English only)   2012-06-25    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module I – Pharmacovigilance systems and their quality systems (English only)   2012-06-25    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module II – Pharmacovigilance system master file (English only)   2012-06-25    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module III – Pharmacovigilance inspections (English only)   2012-12-13    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module IV – Pharmacovigilance audits (English only)   2012-12-13    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module V – Risk management systems (English only)   2012-06-25    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module VI – Management and reporting of adverse reactions to medicinal products (English only)   2012-06-25    
Comments received from public consultation on good pharmacovigilance practices: Good pharmacovigilance practices module VI – Management and reporting of adverse reactions to medicinal products (Rev 1) (English only)   2014-09-15    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module VII – Periodic safety update report (English only)   2012-06-25    
Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VII – Periodic safety update report (Rev 1) (English only)   2013-12-12    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module VIII – Post-authorisation safety studies (English only)   2012-06-25    
Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VIII – Post-authorisation safety studies (Rev. 2) (EMA/813938/2011) (English only)   2016-08-08    
Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 2) (EMA/395730/2012) (English only)   2016-08-08    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module IX – Signal management (English only)   2012-06-25    
Comments received from public consultation on good pharmacovigilance practices (GVP) module X – Additional monitoring (English only)   2013-04-25    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module XV – Safety communication (English only)   2013-01-24    
Comments received from public consultation on good pharmacovigilance practices: GVP module XVI - Risk minimisation measures - Selection of tools and effectiveness indicators (English only)   2014-02-28    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP Module XVI Addendum I – Educational materials (English only)   2015-12-15    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP - Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases (English only)   2013-12-12    
Comments received from public consultation on good pharmacovigilance practices (GVP): GVP annex I – Definitions (English only)   2012-06-25    
Comments received from public consultation on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products (English only)   2016-08-15    

Final versions of GVP chapters with tracked changes

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Document(s) Language Status First published Last updated Effective Date
Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections with tracked changes (English only)   2012-12-13    
Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits with tracked changes (English only)   2012-12-13    
Guideline on good pharmacovigilance practices: Module V – Risk management systems with tracked changes (English only)   2014-04-25    
Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products with track changes (Rev 1) (English only)   2014-09-15    
Guideline on good pharmacovigilance practices: Module VII – Periodic safety update report with tracked changes (English only)   2013-12-12    
Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies with tracked changes (Rev. 2) (English only)   2016-08-08    
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 with tracked changes (Rev. 2) (English only)   2016-08-08    
Guideline on good pharmacovigilance practices: Module X – Additional monitoring with tracked changes (English only)   2013-04-25    
Guideline on good pharmacovigilance practices: Module XV – Safety communication with tracked changes (English only)   2013-01-24    
Guideline on good pharmacovigilance practices: Module XVI– Risk minimisation measures - Selection of tools and effectiveness indicators with tracked changes (English only)   2014-02-28    
Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials with tracked changes (English only)   2015-12-15    
Guideline on good pharmacovigilance practices (GVP) product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases with tracked changes (English only)   2013-12-12    
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products with tracked changes (English only)   2016-08-15    

Related links

These tracked-change versions identify the majority of changes introduced to the public-consultation versions of the documents as the Agency’s response to the comments received from the public consultation, or major changes introduced during a revision in comparison to a previous version, as indicated on the respective cover page. Tracked-change versions are published for transparency purposes only and must not be taken or quoted as the final version. 

Previous versions of GVP chapters and annexes

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Document(s) Language Status First published Last updated Effective Date
Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (English only)   2012-06-25    
Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections (English only)   2012-12-13    
Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits (superseded) (English only) adopted 2012-12-13    
Guideline on good pharmacovigilance practices: Module V – Risk management systems (English only)   2012-06-25    
Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (English only)   2012-06-25    
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report (English only)   2012-06-25    
Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 1) (superseded) (English only)   2013-04-25    
Guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Member States' requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 1) (superseded) (English only)   2013-04-25    
Guideline on good pharmacovigilance practices: Module VIII – Post-authorisation safety studies (English only)   2012-06-25    
Guideline on good pharmacovigilance practices: Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (English only)   2014-02-28    
Guidelines on good pharmacovigilance practices: Annex I - Definitions (Rev 1) (English only)   2012-06-25    
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev 2) (English only)   2014-01-08