Good pharmacovigilance practices
Table of contents
- Introduction
- Final GVP modules
- Final GVP product- or population-specific considerations
- Final GVP annex I - Definitions
- Final GVP annex II - Templates
- Final GVP annex III - Other pharmacovigilance guidance
- Final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance
- Final GVP annex V - Abbreviations
- Public consultations
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 (EMA) 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 was a key deliverable of the 2010 pharmacovigilance legislation.
Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States.
The guideline on GVP is divided into chapters that fall into two categories:
- modules covering major pharmacovigilance processes;
- product- or population-specific considerations.
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 bullet points below Final GVP modules table).
Product- or population-specific considerations
The chapters on product- or population-specific considerations are available for vaccines, biological medicinal products and the paediatric population. EMA plans one more consideration chapter as follows:
Chapter number | Preliminary chapter title | Date of release for public consultation |
P V | Geriatric population | To be announced |
GVP modules and considerations are regularly reviewed for revision needs and schedules.
Archives of documents
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Guideline on good pharmacovigilance practices: Module I – Pharmacovigilance systems and their quality systems (PDF/213.14 KB)
Adopted
First published: 25/06/2012
Last updated: 25/06/2012
Legal effective date: 02/07/2012
Consultation dates: 21/02/2012 to 18/04/2012
EMA/541760/2011 -
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Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (Rev. 2) (PDF/340.71 KB)
Adopted
First published: 25/06/2012
Last updated: 30/03/2017
Legal effective date: 31/03/2017
EMA/816573/2011 -
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Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections (PDF/189.47 KB)
Adopted
First published: 13/12/2012
Last updated: 15/09/2014
Legal effective date: 16/09/2014
EMA/119871/2012 Rev 1 -
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Guideline on good pharmacovigilance practices (GVP) - Module IV – Pharmacovigilance audits (Rev. 1) (PDF/154.02 KB)
Adopted
First published: 12/12/2012
Last updated: 11/08/2015
EMA/228028/2012 Rev 1 -
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Guideline on good pharmacovigilance practices: Module V – Risk management systems (Rev. 2) (PDF/568.8 KB)
Adopted
First published: 25/06/2012
Last updated: 30/03/2017
Legal effective date: 31/03/2017
Consultation dates: 21/02/2012 to 18/04/2012
EMA/838713/2011 -
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Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev. 2) (PDF/2.02 MB)
Adopted
First published: 25/06/2012
Last updated: 02/08/2017
Legal effective date: 22/11/2017
EMA/873138/2011 Rev. 2 -
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Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum I – Duplicate management of suspected adverse reaction reports (PDF/359.92 KB)
Adopted
First published: 28/07/2017
Last updated: 02/08/2017
Legal effective date: 22/11/2017
EMA/405655/2016 -
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Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report (PDF/1.45 MB)
Adopted
First published: 25/06/2012
Last updated: 12/12/2013
Legal effective date: 13/12/2013
Consultation dates: 21/02/2012 to 18/04/2012
EMA/816292/2011 Rev.1* -
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Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 3) (PDF/235.42 KB)
Adopted
First published: 25/06/2012
Last updated: 12/10/2017
Legal effective date: 13/10/2017
EMA/813938/2011 -
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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. 3) (PDF/86.49 KB)
Adopted
First published: 23/06/2020
EMA/395730/2012 Rev. 3 -
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Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1) (PDF/283.21 KB)
Adopted
First published: 25/06/2012
Last updated: 12/10/2017
Legal effective date: 22/11/2017
EMA/827661/2011 -
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Guideline on good pharmacovigilance practices (GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions (PDF/133.95 KB)
Adopted
First published: 12/10/2017
Last updated: 12/10/2017
Legal effective date: 22/11/2017
EMA/209012/2015 -
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Guideline on good pharmacovigilance practices: Module X – Additional monitoring (PDF/271.91 KB)
Adopted
First published: 25/04/2013
Last updated: 25/04/2013
Legal effective date: 25/04/2013
Consultation dates: 27/06/2012 to 24/08/2012
EMA/169546/2012 -
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Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1) (PDF/188.52 KB)
Adopted
First published: 24/01/2013
Last updated: 12/10/2017
Legal effective date: 13/10/2017
EMA/118465/2012 -
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Guideline on good pharmacovigilance practices: Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 2) (PDF/375.58 KB)
Adopted
First published: 28/02/2014
Last updated: 30/03/2017
Legal effective date: 31/03/2017
EMA/204715/2012 -
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Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials (PDF/81.66 KB)
Adopted
First published: 15/12/2015
Last updated: 15/12/2015
Legal effective date: 16/12/2015
EMA/61341/2015
- Where GVP chapters refer to Modules XI or XIV, consult the Agency's page on partners and networks.
- Where GVP chapters refer to Module XII, consult the Agency's page on post-marketing authorisation: regulatory and procedural guidance for human medicinal products.
- Where GVP chapters refer to Module XIII, consult the Agency's page on the incident management plan.
- Please note the document on
reporting requirements of marketing authorisation holders in the EU regarding suspected adverse reactions occurring with medicinal products they donate outside the EU to public health programmes against neglected tropical diseases.
- In relation to the GVP VII module please note that an
explanatory note and a
question and answer guidance document for assessors have been developed to clarify certain aspects of the single assessment that are specific to nationally authorised products. These documents should be considered as interim guidance until the GVP VII module is revised as per the established process. Once the updated GVP module is published this guidance will be removed. These documents can be found on the Periodic safety update reports: questions and answers page.
- 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 referral procedures page.
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Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases (PDF/460.19 KB)
Adopted
First published: 12/12/2013
Last updated: 12/12/2013
Legal effective date: 13/12/2013
EMA/488220/2012 -
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Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products (PDF/377.05 KB)
Adopted
First published: 15/08/2016
Last updated: 15/08/2016
Legal effective date: 16/08/2016
EMA/168402/2014 -
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Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population (PDF/206.02 KB)
Adopted
First published: 07/11/2018
Legal effective date: 08/11/2018
EMA/572054/2016
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Guideline on good pharmacovigilance practices: Annex II – Templates: Cover page of periodic safety update report (PSUR) (PDF/176.08 KB)
Adopted
First published: 25/06/2012
Last updated: 25/04/2013
Legal effective date: 25/04/2013
Consultation dates: 21/02/2012 to 18/04/2012
EMA/170043/2013 -
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Guideline on good pharmacovigilance practices: Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev. 1) (PDF/61.21 KB)
Adopted
First published: 24/01/2013
Last updated: 12/10/2017
Legal effective date: 13/10/2017
EMA/36988/2013 -
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Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC) (PDF/80.24 KB)
Adopted
First published: 12/10/2017
Last updated: 12/10/2017
Legal effective date: 13/10/2017
EMA/334164/2015
For other templates developed outside the GVP process, see:
These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP.
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Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data (PDF/277.32 KB)
Adopted
First published: 14/11/2005
Last updated: 14/11/2005
Legal effective date: 02/05/2006
EMEA/CHMP/313666/2005 -
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Note for guidance: EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (historical) (PDF/840.18 KB)
Adopted
First published: 03/08/2004
Last updated: 22/10/2010
Legal effective date: 07/02/2011
EMA/H/20665/04/Final Rev. 2 -
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Overview of comments received on draft note for guidance: EudraVigilance version 7.1 - Processing of safety messages and individual case safety reports (ICSRs) (PDF/215.05 KB)
First published: 20/11/2009
Last updated: 20/11/2009
EMEA/183240/2008 -
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Draft note for guidance: EudraVigilance Human version 7.1 - Processing of safety messages and individual case safety reports (ICSRs) (PDF/720.45 KB)
Draft: consultation closed
First published: 01/02/2008
Last updated: 01/02/2008
EMEA/553390/2007
For other pharmacovigilance guidance developed outside the GVP process, see:
- Pharmacovigilance: regulatory and procedural guidance
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Consideration on core requirements for RMPs of COVID-19 vaccines
- Signal management
- EudraVigilance
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European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 3
- Union reference dates and submission of periodic safety update reports
- Guideline on registry-based studies - Scientific guideline
- Standards and guidances of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products
Good practice guide on recording, coding, reporting and assessment of medication errors
Good practice guide on risk minimisation and prevention of medication errors
Risk minimisation strategy for high strength and fixed combination insulin products, developed as an addendum to the good practice guide on risk minimisation and prevention of medication errors
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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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... (PDF/177.91 KB)
Adopted
First published: 01/06/1995
Last updated: 01/06/1995
Legal effective date: 01/06/1995
CPMP/ICH/377/95 -
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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 ... (PDF/1.49 MB)
Adopted
First published: 01/09/2005
Last updated: 27/08/2013
Legal effective date: 01/07/2013
CHMP/ICH/287/1995 -
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 B (R3): Questions and answers: Data elements for transmission of individual case safety repo... (PDF/480.36 KB)
Adopted
First published: 01/03/2005
Last updated: 27/07/2017
Legal effective date: 28/07/2016
EMA/CHMP/ICH/3943/2003 -
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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 (PDF/476.27 KB)
Adopted
First published: 31/12/2012
Last updated: 31/12/2012
Legal effective date: 01/01/2013
EMA/CHMP/ICH/544553/1998 -
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5 (PDF/181.92 KB)
Adopted
First published: 30/11/2003
Last updated: 30/11/2003
Legal effective date: 01/05/2004
CPMP/ICH/3945/03 -
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5 (PDF/225.43 KB)
Adopted
First published: 31/12/2004
Last updated: 31/12/2004
Legal effective date: 01/06/2005
CPMP/ICH/5716/03 -
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ICH guideline E2F on development safety update report - Step 5 (PDF/352.87 KB)
Adopted
First published: 30/09/2010
Last updated: 30/09/2010
Legal effective date: 01/09/2011
EMA/CHMP/ICH/309348/2008
- E2C(R2)Implementation working group ICH E2C(R2) Guideline: Periodic benefit-risk evaluation report questions & answers
- ICH M1 Medical Dictionary for Regulatory Activites (MedDRA)
- MedDRA support documentation
- ICH M2 electronic standards for the transfer of regulatory information (ESTRI) is available on multidisciplinary guidelines.
Those participating in the public consultation are asked to submit comments via the EU survey tool linked here.
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Draft guideline on good pharmacovigilance practices: Product- or population-specific considerations III: Pregnant and breastfeeding women (PDF/475.52 KB)
Draft: consultation closed
First published: 11/12/2019
Consultation dates: 11/12/2019 to 28/02/2020
EMA/653036/2019 -
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Guideline on good pharmacovigilance practices (GVP): Module XVI - Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3) (PDF/422.3 KB)
Draft: consultation closed
First published: 03/02/2021
Consultation dates: 03/02/2021 to 28/04/2021
EMA/204715/2012 Rev. 3 -
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Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II - Methods for effectiveness evaluation (PDF/335.45 KB)
Draft: consultation closed
First published: 03/02/2021
Consultation dates: 03/02/2021 to 28/04/2021
EMA/419982/2019