Good pharmacovigilance practices

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

• Archive of development of GVP
• Superseded pharmacovigilance guidance documents

Also on this topic

• Archive of development of good pharmacovigilance practices
• Superseded pharmacovigilance guidance documents

Introduction

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with release of Addendum III of Module XVI on pregnancy prevention programmes for public consultation

Reference Number: EMA/95595/2022

Final GVP modules

Guideline 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/541760/2011

Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (Rev. 2)

AdoptedLegal effective date: 31/03/2017Reference Number: EMA/816573/2011

Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections

AdoptedLegal effective date: 16/09/2014Reference Number: EMA/119871/2012 Rev 1Summary:

This Module contains guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU and outlines the role of the different parties involved. General guidance is provided under III.B., while III.C. covers the overall operation of pharmacovigilance inspections in the EU.

Guideline on good pharmacovigilance practices (GVP) - Module IV – Pharmacovigilance audits (Rev. 1)

AdoptedReference Number: EMA/228028/2012 Rev 1

Guideline 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/838713/2011

Guideline 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. 2Summary:

GVP Module VI – Management and reporting of adverse reactions to

medicinal products (EMA/873138/2011 Rev. 2)

Guideline on good pharmacovigilance practices (GVP) - Module VI Addendum I – Duplicate management of suspected adverse reaction reports

AdoptedLegal effective date: 22/11/2017Reference Number: EMA/405655/2016Summary:

Module VI Addendum I – Duplicate management of suspected adverse reaction reports

Guideline 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*

Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 3)

AdoptedLegal effective date: 13/10/2017Reference Number: EMA/813938/2011

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)

AdoptedReference Number: EMA/395730/2012 Rev. 3

Guideline on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1)

AdoptedLegal effective date: 22/11/2017Reference Number: EMA/827661/2011Summary:

Revision 1 is a major revision with modifications throughout and contains the following:

- Revised definition and process for emerging safety issues, previously addressed in GVP Module VI (IX.A.1.1. and IX.C.2.);

- Streamlined information on scientific aspects of signal management (IX.B.2. to IX.B.4.), statistical aspects now addressed in Addendum I;

Guideline 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/209012/2015Summary:

This guidance extends and updates some of the information given in the Guideline on the Use of Statistical Signal Detection Methods in the EudraVigilance Data Analysis System (EMEA/106464/2006 rev. 1) and supersedes the previous advice in the areas addressed by this new guidance.

Guideline on good pharmacovigilance practices: Module X – Additional monitoring

Consultation dates: 27/06/2012 to 24/08/2012AdoptedLegal effective date: 25/04/2013Reference Number: EMA/169546/2012

Guideline on good pharmacovigilance practices: Module XV – Safety communication (Rev. 1)

AdoptedLegal effective date: 13/10/2017Reference Number: EMA/118465/2012

Guideline on good pharmacovigilance practices: Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 2)

AdoptedLegal effective date: 31/03/2017Reference Number: EMA/204715/2012

Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Educational materials

AdoptedLegal effective date: 16/12/2015Reference Number: EMA/61341/2015Summary:

Module XVI Addendum I – Educational materials

• 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 European Union (EU) regarding suspected adverse reactions occurring with medicinal products they donate outside the EU to public health programmes against ....
• In relation to the GVP VII module please note that an Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note and a Questions and answers on PSUSA: 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/488220/2012

Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products

AdoptedLegal effective date: 16/08/2016Reference Number: EMA/168402/2014

Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population

AdoptedLegal effective date: 08/11/2018Reference Number: EMA/572054/2016

• Guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products

Final GVP annex I - Definitions

Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev. 4)

AdoptedLegal effective date: 13/10/2017Reference Number: EMA/876333/2011

Final 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/170043/2013

Guideline on good pharmacovigilance practices: Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (Rev. 1)

AdoptedLegal effective date: 13/10/2017Reference Number: EMA/36988/2013

Guideline 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/334164/2015

For other templates developed outside the GVP process, see:

• Risk-management plans
• Pharmacovigilance: regulatory and procedural guidance

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/313666/2005

Note for guidance: EudraVigilance Human – Processing of safety messages and individual case safety reports (ICSRs) (historical)

AdoptedLegal effective date: 07/02/2011Reference Number: EMA/H/20665/04/Final Rev. 2

Overview 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/183240/2008

Draft note for guidance: EudraVigilance Human version 7.1 - Processing of safety messages and individual case safety reports (ICSRs)

Draft: consultation closedReference Number: EMEA/553390/2007

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 3
• 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 of procedure.

Guideline on specific adverse reaction follow-up questionnaires (Specific AR FUQ)

Consultation dates: 06/12/2023 to 09/02/2024Draft: consultation openReference Number: EMA/PRAC/490455/2023Summary:

This draft guideline on Specific Adverse Reaction Follow-up questionnaires (Specific AR FUQ) gives detailed guidance on how and when to use Specific AR FUQ in risk management as part of routine pharmacovigilance activities. 

 

It was developed by the Pharmacovigilance risk assessment committee (PRAC) to provide guidance on the use of Specific AR FUQs as part the Risk management plan (RMP) and listed in Annex 4 of the RMP.

 

It focuses on Specific AR FUQs developed by the MAHs at the request of NCAs. It emphasizes the importance of obtaining structured and detailed information on reported adverse reactions that may impact the benefit-risk balance of a product or have implications for public health.

 

It contains three main elements:

 

• Providing general guidance when to request, when and how to use Specific AR FUQs to Marketing authorisation holders (MAHs) and competent authorities in Member States (NCAs); Pharmacovigilance risk assessment committee (PRAC), pharmacovigilance and clinical assessors, pharmacovigilance (GVP) inspectors, and the European Medicines Agency (EMA)
• Developing guidance that can be used by MAHs and recommend if and how approved Specific AR FUQs could be published
• Considerations on discontinuation and removal of Specific AR FUQs  

All interested stakeholders are invited to comment on the draft guideline.

 

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...

AdoptedLegal effective date: 01/06/1995Reference Number: CPMP/ICH/377/95

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 ...

AdoptedLegal effective date: 01/07/2013Reference Number: CHMP/ICH/287/1995

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...

AdoptedLegal effective date: 28/07/2016Reference Number: EMA/CHMP/ICH/3943/2003

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

AdoptedLegal effective date: 01/01/2013Reference Number: EMA/CHMP/ICH/544553/1998Summary:

The Periodic Benefit-Risk Evaluation Report (PBRER) described in this guideline is intended to be a common standard for periodic benefit-risk evaluation reporting on marketed products (including approved drugs that are under further study) among the ICH regions.

This guideline defines the recommended format and content of a PBRER and provides an outline of points to be considered in its preparation and submission.

International 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/3945/03

International 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/5716/03

ICH guideline E2F on development safety update report - Step 5

AdoptedLegal effective date: 01/09/2011Reference Number: EMA/CHMP/ICH/309348/2008Summary:

The DSUR proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development among the ICH regions. US and EU regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the US IND Annual Report and the EU Annual Safety Report, respectively, and can therefore take the place of these existing reports. This guideline defines the recommended content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.

• 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/135814/2013

Public 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/608947/2021Summary:

This new guidance defines the elements of a pregnancy prevention programme and provides for deciding when such programme is needed or other risk minimisation measures are considered appropriate to avoid adverse pregnancy outcomes due to use of medicines and to preserve health of both the mother and the child.

Those participating in the public consultation are asked to submit comments via the EU survey tool linked here.

Those participating in the public consultation are asked to submit comments via the EU survey tool linked here.

Draft 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/653036/2019Summary:

This product- and population- specific considerations chapter P.III of the good pharmacovigilance practices (GVP) aims to provide guidance to marketing authorisation applicants/holders, competent authorities of Member States and the Agency for facilitating appropriate pharmacovigilance for medicinal products that may be used in pregnant or breastfeeding women.

Comments should be provided using .

Guideline on good pharmacovigilance practices (GVP): Module XVI - Risk minimisation measures: selection of tools and effectiveness indicators (Rev 3)

Consultation dates: 03/02/2021 to 28/04/2021Draft: consultation closedReference Number: EMA/204715/2012 Rev. 3Summary:

Risk management includes the identification, characterisation (including quantification), prevention and minimisation of risks. Risk management systems consist of pharmacovigilance activities and interventions relating to individual medicinal products for this purpose, including the assessment of the effectiveness of those activities and interventions, in accordance with Article 1(28b) of Directive 2001/83/EC. The objectives of risk minimisation are achieved through the implementation of risk minimisation measures (RMM) required by the competent authorities and generation of evidence that these measures are effective.

Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II - Methods for effectiveness evaluation

Consultation dates: 03/02/2021 to 28/04/2021Draft: consultation closedReference Number: EMA/419982/2019Summary:

This Addendum to GVP Module XVI provides additional guidance for marketing authorisation holders and competent authorities on data sources and methodologies for monitoring outcomes of risk minimisation measures (RMM) in line with the principles for RMM effectiveness evaluation laid down in GVP Module XVI. Depending on the risk minimisation objective, studies evaluating RMM effectiveness may integrate different quantitative measurements and qualitative research approaches to evaluate risk minimisation outcomes for individual tools or sets of RMM described in GVP Module XVI.

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