INOPP Forum
EMA GVP Modules
Quote from VigiServe Admin on August 31, 2024, 1:34 PMGuideline on good pharmacovigilance practices: Module I – Pharmacovigilance systems and their quality systems
Consultation dates:21/02/2012 to 18/04/2012AdoptedLegal effective date:02/07/2012Reference Number:EMA/541760/2011English (EN) (213.14 KB - PDF)
First published: 25/06/2012Last updated: 25/06/2012Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (Rev. 2)
AdoptedLegal effective date:31/03/2017Reference Number:EMA/816573/2011English (EN) (340.71 KB - PDF)
First published: 25/06/2012Last updated: 30/03/2017Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections
AdoptedLegal effective date:16/09/2014Reference Number:EMA/119871/2012 Rev 1English (EN) (189.47 KB - PDF)
First published: 13/12/2012Last updated: 15/09/2014Guideline on good pharmacovigilance practices (GVP) - Module IV – Pharmacovigilance audits (Rev. 1)
AdoptedReference Number:EMA/228028/2012 Rev 1English (EN) (154.02 KB - PDF)
First published: 12/12/2012Last updated: 11/08/2015Guideline on good pharmacovigilance practices: Module V – Risk management systems (Rev. 2)
Consultation dates:21/02/2012 to 18/04/2012AdoptedLegal effective date:31/03/2017Reference Number:EMA/838713/2011English (EN) (568.8 KB - PDF)
First published: 25/06/2012Last updated: 30/03/2017Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev. 2)
AdoptedLegal effective date:22/11/2017Reference Number:EMA/873138/2011 Rev. 2English (EN) (2.02 MB - PDF)
First published: 25/06/2012Last updated: 02/08/2017Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum I – Duplicate management of suspected adverse reaction reports
AdoptedLegal effective date:22/11/2017Reference Number:EMA/405655/2016English (EN) (359.92 KB - PDF)
First published: 28/07/2017Last updated: 02/08/2017Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report
Consultation dates:21/02/2012 to 18/04/2012AdoptedLegal effective date:13/12/2013Reference Number:EMA/816292/2011 Rev.1*English (EN) (1.45 MB - PDF)
First published: 25/06/2012Last updated: 12/12/2013Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 3)
AdoptedLegal effective date:13/10/2017Reference Number:EMA/813938/2011English (EN) (235.42 KB - PDF)
First published: 25/06/2012Last updated: 12/10/2017Guideline 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)
AdoptedReference Number:EMA/395730/2012 Rev. 3English (EN) (86.49 KB - PDF)
First published: 23/06/2020Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1)
AdoptedLegal effective date:22/11/2017Reference Number:EMA/827661/2011English (EN) (283.21 KB - PDF)
First published: 25/06/2012Last updated: 12/10/2017Guideline on good pharmacovigilance practices (GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions
AdoptedLegal effective date:22/11/2017Reference Number:EMA/209012/2015English (EN) (133.95 KB - PDF)
First published: 12/10/2017Last updated: 12/10/2017Guideline on good pharmacovigilance practices: Module X – Additional monitoring
Consultation dates:27/06/2012 to 24/08/2012AdoptedLegal effective date:25/04/2013Reference Number:EMA/169546/2012English (EN) (271.91 KB - PDF)
First published: 25/04/2013Last updated: 25/04/2013Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1)
AdoptedLegal effective date:13/10/2017Reference Number:EMA/118465/2012English (EN) (188.52 KB - PDF)
First published: 24/01/2013Last updated: 12/10/2017Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)
Legal effective date:06/08/2024Reference Number:EMA/204715/2012English (EN) (937.46 KB - PDF)
First published: 05/08/2024Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures
Legal effective date:06/08/2024Reference Number:EMA/419982/2019English (EN) (624.08 KB - PDF)
First published: 05/08/2024
- 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.
Final GVP product- or population-specific considerations
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases
AdoptedLegal effective date:13/12/2013Reference Number:EMA/488220/2012English (EN) (460.19 KB - PDF)
First published: 12/12/2013Last updated: 12/12/2013Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products
AdoptedLegal effective date:16/08/2016Reference Number:EMA/168402/2014English (EN) (377.05 KB - PDF)
First published: 15/08/2016Last updated: 15/08/2016Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population
AdoptedLegal effective date:08/11/2018Reference Number:EMA/572054/2016English (EN) (206.02 KB - PDF)
First published: 07/11/2018Final GVP annex I - Definitions
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)
Legal effective date:06/08/2024Reference Number:EMA/876333/2011English (EN) (335.04 KB - PDF)
First published: 25/06/2012Last updated: 05/08/2024Final GVP annex II - Templates
Guideline on good pharmacovigilance practices: Annex II – Templates: Cover page of periodic safety update report (PSUR)
Consultation dates:21/02/2012 to 18/04/2012AdoptedLegal effective date:25/04/2013Reference Number:EMA/170043/2013English (EN) (176.08 KB - PDF)
First published: 25/06/2012Last updated: 25/04/2013Guideline on good pharmacovigilance practices: Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev. 1)
AdoptedLegal effective date:13/10/2017Reference Number:EMA/36988/2013English (EN) (61.21 KB - PDF)
First published: 24/01/2013Last updated: 12/10/2017Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)
AdoptedLegal effective date:13/10/2017Reference Number:EMA/334164/2015English (EN) (80.24 KB - PDF)
First published: 12/10/2017Last updated: 12/10/2017For other templates developed outside the GVP process, see:
Final GVP annex III - Other pharmacovigilance guidance
These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP.
Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data
AdoptedLegal effective date:02/05/2006Reference Number:EMEA/CHMP/313666/2005English (EN) (277.32 KB - PDF)
First published: 14/11/2005Last updated: 14/11/2005Overview of comments received on draft note for guidance: EudraVigilance version 7.1 - Processing of safety messages and individual case safety reports (ICSRs)
Reference Number:EMEA/183240/2008English (EN) (215.05 KB - PDF)
First published: 20/11/2009Last updated: 20/11/2009Draft guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products
Draft: consultation closedReference Number:EMEA/149995/2008English (EN) (162.51 KB - PDF)
First published: 06/05/2008Last updated: 06/05/2008For other pharmacovigilance guidance developed outside the GVP process, see:
- Pharmacovigilance: regulatory and procedural guidance
- Consideration on core requirements for RMPs of COVID-19 vaccines
- Signal management
- EudraVigilance
- European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 4
- Union reference dates and submission of periodic safety update reports
- Guideline on registry-based studies
- 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, addendum to the good practice guide on risk minimisation and prevention of medication errors
Also, note the PRAC rules procedure.
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
Consultation dates:06/12/2023 to 09/02/2024Draft: consultation closedReference Number:EMA/PRAC/490455/2023English (EN) (295.46 KB - PDF)
First published: 06/12/2023Final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance
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...
AdoptedLegal effective date:01/06/1995Reference Number:CPMP/ICH/377/95English (EN) (177.91 KB - PDF)
First published: 01/06/1995Last updated: 01/06/1995International 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 ...
AdoptedLegal effective date:01/07/2013Reference Number:CHMP/ICH/287/1995English (EN) (1.49 MB - PDF)
First published: 01/09/2005Last updated: 27/08/2013International 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...
AdoptedLegal effective date:28/07/2016Reference Number:EMA/CHMP/ICH/3943/2003English (EN) (480.36 KB - PDF)
First published: 01/03/2005Last updated: 27/07/2017International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline E2C (R2) on periodic benefit-risk evaluation report - Step 5
AdoptedLegal effective date:01/01/2013Reference Number:EMA/CHMP/ICH/544553/1998English (EN) (476.27 KB - PDF)
First published: 31/12/2012Last updated: 31/12/2012International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5
AdoptedLegal effective date:01/05/2004Reference Number:CPMP/ICH/3945/03English (EN) (181.92 KB - PDF)
First published: 30/11/2003Last updated: 30/11/2003International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5
AdoptedLegal effective date:01/06/2005Reference Number:CPMP/ICH/5716/03English (EN) (225.43 KB - PDF)
First published: 31/12/2004Last updated: 31/12/2004ICH guideline E2F on development safety update report - Step 5
AdoptedLegal effective date:01/09/2011Reference Number:EMA/CHMP/ICH/309348/2008English (EN) (352.87 KB - PDF)
First published: 30/09/2010Last updated: 30/09/2010
- 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.
Final GVP annex V - Abbreviations
Guideline on good pharmacovigilance practices: Annex V – Abbreviations (Rev. 1)
AdoptedLegal effective date:13/10/2017Reference Number:EMA/135814/2013English (EN) (84.58 KB - PDF)
First published: 25/04/2013Last updated: 12/10/2017Public consultations
Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum III – Pregnancy prevention programme and other pregnancy-specific risk minimisation measures
Consultation dates:14/03/2022 to 31/05/2022Draft: consultation closedReference Number:EMA/608947/2021English (EN) (212.27 KB - PDF)
First published: 14/03/2022Draft guideline on good pharmacovigilance practices: Product- or population-specific considerations III: Pregnant and breastfeeding women
Consultation dates:11/12/2019 to 28/02/2020Draft: consultation closedReference Number:EMA/653036/2019English (EN) (475.52 KB - PDF)
First published: 11/12/2019
Guideline on good pharmacovigilance practices: Module I – Pharmacovigilance systems and their quality systems
English (EN) (213.14 KB - PDF)
Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (Rev. 2)
English (EN) (340.71 KB - PDF)
Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections
English (EN) (189.47 KB - PDF)
Guideline on good pharmacovigilance practices (GVP) - Module IV – Pharmacovigilance audits (Rev. 1)
English (EN) (154.02 KB - PDF)
Guideline on good pharmacovigilance practices: Module V – Risk management systems (Rev. 2)
English (EN) (568.8 KB - PDF)
Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev. 2)
English (EN) (2.02 MB - PDF)
Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum I – Duplicate management of suspected adverse reaction reports
English (EN) (359.92 KB - PDF)
Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report
English (EN) (1.45 MB - PDF)
Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 3)
English (EN) (235.42 KB - PDF)
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)
English (EN) (86.49 KB - PDF)
Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1)
English (EN) (283.21 KB - PDF)
Guideline on good pharmacovigilance practices (GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions
English (EN) (133.95 KB - PDF)
Guideline on good pharmacovigilance practices: Module X – Additional monitoring
English (EN) (271.91 KB - PDF)
Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1)
English (EN) (188.52 KB - PDF)
Guideline on good pharmacovigilance practices (GVP) Module XVI – Risk minimisation measures (Rev 3)
English (EN) (937.46 KB - PDF)
Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II – Methods for evaluating effectiveness of risk minimisation measures
English (EN) (624.08 KB - PDF)
- 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.
Final GVP product- or population-specific considerations
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases
English (EN) (460.19 KB - PDF)
Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products
English (EN) (377.05 KB - PDF)
Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population
English (EN) (206.02 KB - PDF)
Final GVP annex I - Definitions
Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 5)
English (EN) (335.04 KB - PDF)
Final GVP annex II - Templates
Guideline on good pharmacovigilance practices: Annex II – Templates: Cover page of periodic safety update report (PSUR)
English (EN) (176.08 KB - PDF)
Guideline on good pharmacovigilance practices: Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev. 1)
English (EN) (61.21 KB - PDF)
Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)
English (EN) (80.24 KB - PDF)
For other templates developed outside the GVP process, see:
Final GVP annex III - Other pharmacovigilance guidance
These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP.
Guideline on the exposure to medicinal products during pregnancy: Need for post-authorisation data
English (EN) (277.32 KB - PDF)
Overview of comments received on draft note for guidance: EudraVigilance version 7.1 - Processing of safety messages and individual case safety reports (ICSRs)
English (EN) (215.05 KB - PDF)
Draft guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products
English (EN) (162.51 KB - PDF)
For other pharmacovigilance guidance developed outside the GVP process, see:
- Pharmacovigilance: regulatory and procedural guidance
- Consideration on core requirements for RMPs of COVID-19 vaccines
- Signal management
- EudraVigilance
- European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 4
- Union reference dates and submission of periodic safety update reports
- Guideline on registry-based studies
- 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, addendum to the good practice guide on risk minimisation and prevention of medication errors
Also, note the PRAC rules procedure.
Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)
English (EN) (295.46 KB - PDF)
Final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance
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...
English (EN) (177.91 KB - PDF)
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 ...
English (EN) (1.49 MB - PDF)
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...
English (EN) (480.36 KB - PDF)
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 (EN) (476.27 KB - PDF)
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 (EN) (181.92 KB - PDF)
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5
English (EN) (225.43 KB - PDF)
ICH guideline E2F on development safety update report - Step 5
English (EN) (352.87 KB - PDF)
- 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.
Final GVP annex V - Abbreviations
Guideline on good pharmacovigilance practices: Annex V – Abbreviations (Rev. 1)
English (EN) (84.58 KB - PDF)
Public consultations
Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum III – Pregnancy prevention programme and other pregnancy-specific risk minimisation measures
English (EN) (212.27 KB - PDF)
Draft guideline on good pharmacovigilance practices: Product- or population-specific considerations III: Pregnant and breastfeeding women
English (EN) (475.52 KB - PDF)