Archive of development of good pharmacovigilance practices

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

Introductory cover notes

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with new Addendum II to Module VI on masking of personal data in individual case safety reports submitted to EudraVigilance

Reference Number: EMA/236736/2025

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final revision 3 of Module XVI on risk minimisation measures and its Addendum II on their effectiveness evaluation, and revision 5 of Annex I on definitions

Reference Number: EMA/340669/2024

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

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, revision 3 of Module XVI on risk minimisation measures and its Addendum II on methods for their effectiveness evaluation for public consultation (2021)

Reference Number: EMA/54854/2021

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 3 of Addendum I of Module VIII on requirements and recommendations for the submission of information (2020)

Reference Number: EMA/261052/2020 Summary:

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 3 of Addendum I of Module VIII on requirements and recommendations for the submission of information on non-interventional post-authorisation safety

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women

Reference Number: EMA/659929/2019

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.IV on pharmacovigilance for the paediatric population finalised post-public consultation

Reference Number: EMA/722239/2018

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated on 12 October 2017

Reference Number: EMA/213497/2017

Guidelines on good pharmacovigilance practices (GVP) - Introductory cover note, last updated with revision 2 of module VI on ICSRs finalised post-public consultation, its new addendum on duplicate management and the cons...

Reference Number: EMA/213497/2017 Summary:

Introductory cover note, last updated with revision 2 of module VI on ICSRs finalised post-public consultation, its new addendum on duplicate management and the considerations chapter IV on the paediatric population for public consultation

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with revision 2 of module V on risk management systems finalised post-public consultation, related revision 2 of module XVI and ...

Reference Number: EMA/213497/2017

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with considerations P.II on biological medicinal products finalised post-public consultation

Reference Number: EMA/529641/2016

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...

Reference Number: EMA/510998/2016 Summary:

New legislation for pharmacovigilance applies in the European Union (EU) since July 2012, and to support its implementation, a set of guidelines for the conduct of pharmacovigilance in the EU has been developed which, as they have been adopted, replaced the previous set in Volume 9A of the Rules Governing Medicinal Products in the EU.

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.

Reference Number: EMA/136477/2016

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 safet...

Reference Number: EMA/772189/2015 Summary:

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

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-authorisatio...

Reference Number: EMA/501523/2015

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

Reference Number: EMA/239760/2015

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 r...

Reference Number: EMA/475236/2014

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 o...

Reference Number: EMA/213031/2014

Guideline on good pharmacovigilance practices: Introductory cover note, last updated with final new module on risk minimisation measures

Reference Number: EMA/61203/2014

Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with final definition annex revision 2

Reference Number: EMA/781168/2013

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with final module VII revision 1 on PSURs and considerations I on vaccines

Reference Number: EMA/757334/2013

Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with launch of public consultation of module VI revision 1 and module XVI

Reference Number: EMA/321625/2013

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 G...

Reference Number: EMA/237383/2013

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

Reference Number: EMA/131811/2013

Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with finalisation of module XV

Reference Number: EMA/34842/2013

Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with finalisation of modules III and IV

Reference Number: EMA/798404/2012 Summary:

This new guidance on good pharmacovigilance practices (GVP) is organised into Modules. The first seven Modules on prioritised topics were consulted between 21 February and 18 April 2012 and revised, taking into account the comments received from stakeholders. They are available in their final versions and came into force on 2 July 2012.

Guidelines on good pharmacovigilance practices: Introductory cover note, last updated with public consultation launch of draft modules IV and XV

Reference Number: EMA/500020/2012

Guidelines on good pharmacovigilance practices: Introductory cover note to finalisation of the first seven modules and public consultation of draft modules III and X

Reference Number: EMA/426200/2012

Guidelines on good pharmacovigilance practices: Introductory cover note to the public consultation of the first seven modules

Reference Number: EMA/55612/2012

Draft GVP chapters and annexes for closed public consultations

Draft guideline on good pharmacovigilance practices: Module I - Pharmacovigilance systems and their quality systems

Draft: consultation closed Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/541760/2011 Summary:

This Module contains guidance for the establishment and maintenance of quality assured pharmacovigilance systems for marketing authorisation holders, competent authorities of Member States and the European Medicines Agency. How the systems of these organisations interact while undertaking specific pharmacovigilance processes is described in each respective Module of good pharmacovigilance practices (GVP).

Draft guideline on good pharmacovigilance practices: Module II - Pharmacovigilance system master file

Draft: consultation closed Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/816573/2011 Summary:

This Module provides detailed guidance regarding the requirements for the pharmacovigilance system master file, including its maintenance, content and associated submissions to competent authorities, applicable from July 2012, during the transition period (as described in Article 2 of Directive 2010/84/EU and Article 3 of Regulation (EU) No 1235/2010, and after 2015.

Draft guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections

Draft: consultation closed Consultation dates: 27/06/2012 to 24/08/2012 Reference Number: EMA/119871/2012 Summary:

This module contains guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the European Union and outlines the role of the different parties involved.

Draft guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits

Draft: consultation closed Consultation dates: 26/07/2012 to 21/09/2012 Reference Number: EMA/228028/2012 Summary:

This module provides guidance on planning and conducting the legally required audits, and in respect of the operation of the European Union regulatory network, the role, context and management of pharmacovigilance audit activity. This module is intended to facilitate the performance of pharmacovigilance audits, especially to promote harmonisation, and encourage consistency and simplification of the audit process.

Draft guideline on good pharmacovigilance practices: Module V - Risk management systems

Draft: consultation closed Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/838713/2011 Summary:

This Module provides guidance on the description of risk management systems for medicinal products in the format of risk management plans (RMPs). RMPs address identified as well as potential risks and areas where further research is needed, and if necessry, contain specific risk minimisation activities for the safe use of the product.

Draft guideline on good pharmacovigilance practices (GVP) - Module V – Risk management systems (Rev 2)

Draft: consultation closed Consultation dates: 29/02/2016 to 31/05/2016 Reference Number: EMA/838713/2011 Rev. 2 Summary:

Good pharmacovigilance practices (GVP) module V, released in 2012, advises developers of medicines, marketing authorisation holders and regulators on the design of effective risk management systems and plans. This first major revision clarifies the activities a risk management plan should focus on during the life cycle of a product. This will help to ensure that a risk-proportionate planning of activities directs resources to areas where the need for additional information and risk minimisation is greatest.

Draft guideline on good pharmacovigilance practices: Module VI - Management and reporting of adverse reactions to medicinal products

Draft: consultation closed Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/873138/2011 Summary:

This Module addresses the legal requirements detailed in Title IX of Directive 2001/83/EC and Chapter 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions associated with medicinal products for human use authorised in the European Union (EU). Recommendations regarding the reporting of suspected adverse reactions occurring in special situations are also included in this Module.

Draft guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (Rev 1)

Draft: consultation closed Consultation dates: 07/06/2013 to 05/08/2013 Reference Number: EMA/873138/2011 Rev 1 Summary:

This module addresses the legal requirements detailed in title IX of Directive 2001/83/EC and chapter 3 of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, marketing-authorisation holders and the European Medicines Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union.

Draft guideline on good pharmacovigilance practices (GVP) - Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 2)

Draft: consultation closed Consultation dates: 08/08/2016 to 14/10/2016 Reference Number: EMA/873138/2011 Summary:

This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC 183 and Chapter 3 of Title II of Regulation (EC) No 726/2004, which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU). Recommendations regarding the reporting of emerging safety issues or of suspected adverse reactions occurring in special situations are also presented in this Module.

Draft guideline on good pharmacovigilance practices: Module VII - Periodic safety update report

Draft: consultation closed Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/816292/2011 Summary:

This Module contains guidance for the preparation, submission and assessment of periodic safety update reports (PSURs). PSURs are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post-authorisation phase.

Draft guideline on good pharmacovigilance practices: Module VII – Periodic safety update report (Rev 1)

Draft: consultation closed Consultation dates: 25/04/2013 to 25/06/2013 Reference Number: EMA/816292/2011 Summary:

This revision contains updates in VII.B and VII.C.5. following finalisation of the ICH-E2C(R2) guideline on 'Periodic Benefit-Risk Evaluation Report (PBRER)', which reached Step 4 of the ICH process in November 2012, in order to harmonise the principles and agreements reached by the ICH Expert Working Group.

Draft guideline on good pharmacovigilance practices: Module VIII - Post-authorisation safety studies

Draft: consultation closed Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/813938/2011 Summary:

This Module concerns post-authorisation safety studies (PASSs). A PASS is defined as any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures [DIR Art 1(15)].

Draft guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 2)

Draft: consultation closed Consultation dates: 11/08/2015 to 09/10/2015 Reference Number: EMA/813938/2011 Rev. 2 Summary:

A post-authorisation safety study (PASS) is defined in Directive 2001/83/EC (DIR) Art 1(15) as any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures. This module concerns PASS which are clinical trials or non-interventional studies, with a main focus on non-interventional PASS. It does not address non-clinical safety studies.

Draft guideline on good pharmacovigilance practices (GVP) - Module VIII Addendum I – Requirements for transmission of information on non-interventional post-authorisation safety studies (Rev. 2)

Draft: consultation closed Consultation dates: 11/08/2015 to 09/10/2015 Reference Number: EMA/395730/2012 Summary:

This addendum specifies requirements for the transmission of study protocols, updated protocols following substantial amendments, final study reports and progress reports if requested on post-authorisation safety studies initiated, managed or financed by marketing authorisation holders voluntarily or pursuant to an obligation. Where the full statistical analytical plan is not included in the protocol, it should be reported following the same requirements as for the study protocol.

Draft guideline on good pharmacovigilance practices: Module IX - Signal management

Draft: consultation closed Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/827661/2011 Summary:

The objectives of this Module are to provide general guidance and requirements on structures and processes involved in signal management and to describe how these structures and processes are applied in the setting of the European Union pharmacovigilance and regulatory network in order to detect whether there are new risks or whether risks have changed.

Draft guideline on good pharmacovigilance practices (GVP) - Module IX – Signal management (Rev. 1)

Draft: consultation closed Consultation dates: 08/08/2016 to 14/10/2016 Reference Number: EMA/827661/2011 Summary:

Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal management in the European Union (EU) [DIR Art 107h, REG Art 28a, IR Chapter III]. In this Module, all applicable legal requirements are referenced as explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”.

Draft guideline on good pharmacovigilance practices (GVP) - Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

Draft: consultation closed Consultation dates: 08/08/2016 to 14/10/2016 Reference Number: EMA/209012/2015 Summary:

Monitoring of databases of spontaneously reported suspected adverse reactions (in the format of individual case safety reports (ICSRs), see GVP Module VI) is an established method of signal detection. The monitoring process is facilitated by statistical summaries of the information received for each “drug-event” combination over defined time periods.

Draft guideline on good pharmacovigilance practices: Module X – Additional monitoring

Draft: consultation closed Consultation dates: 27/06/2012 to 24/08/2012 Reference Number: EMA/169546/2012 Summary:

This module provides general principles for assigning additional monitoring status to medicinal products and on the communication and transparency aspects. It also describes the operation of the European Union network regarding the supervision of additional monitoring status, the communication strategy and the impact on pharmacovigilance activities.

Draft guideline on good pharmacovigilance practices: Module XV – Safety communication

Draft: consultation closed Consultation dates: 26/07/2012 to 21/09/2012 Reference Number: EMA/118465/2012 Summary:

This module provides guidance to marketing-authorisation holders, competent authorities in Member States and the Agency on how to communicate and coordinate safety information in the European Union.

Draft guideline on good pharmacovigilance practices (GVP): Module XV – Safety communication (Rev. 1)

Draft: consultation closed Consultation dates: 15/12/2015 to 29/02/2016 Reference Number: EMA/118465/2012 Summary:

Module XV – Safety communication (Rev 1.)

Draft guideline on good pharmacovigilance practices: Module XVI – Risk-minimisation measures: selection of tools and effectiveness indicators

Draft: consultation closed Consultation dates: 07/06/2013 to 05/08/2013 Reference Number: EMA/204715/2012 Summary:

Risk-minimisation measures are public-health interventions intended to prevent or reduce the occurrence of adverse reactions associated with the exposure to a medicine, or to reduce their severity or impact on the patient should adverse reactions occur. Planning and implementing risk-minimisation measures and assessing their effectiveness are key elements of risk management.

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

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

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.

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

Draft: consultation closed Consultation dates: 27/04/2015 to 30/06/2015 Reference Number: EMA/61341/2015

Draft guideline on good pharmacovigilance practices (GVP): Module XVI Addendum III (renumbered to Addendum I after finalisation) – Pregnancy prevention programme and other pregnancy-specific risk minimisation measures

Draft: consultation closed Consultation dates: 14/03/2022 to 31/05/2022 Reference Number: EMA/608947/2021 Summary:

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.

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

Consultation dates: 03/02/2021 to 28/04/2021 Reference Number: EMA/419982/2019

Draft guideline on good pharmacovigilance practices (GVP): Product-or population-specific considerations I: Vaccines for prophylaxis against infectious diseases

Draft: consultation closed Consultation dates: 12/04/2013 to 12/06/2013 Reference Number: EMA/488220/2012 Summary:

The objective of this module is to strengthen the conduct of pharmacovigilance for vaccines. It should be noted that the overall objectives and processes of pharmacovigilance are no different for vaccines and other types of medicinal products and this guidance does not replace the information provided in the other modules of the good pharmacovigilance practices (GVP). This module focuses on vaccine-specific aspects and unique challenges that should be borne in mind when designing and implementing pharmacovigilance activities for vaccines.

Draft guideline on good pharmacovigilance practices (GVP): P I - Vaccines for prophylaxis against infectious diseases – Definitions for inclusion in GVP annex I

Draft: consultation closed Consultation dates: 12/04/2013 to 12/06/2013 Reference Number: EMA/109434/2013

Draft guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations II: biological medicinal products

Draft: consultation closed Consultation dates: 15/12/2015 to 29/02/2016 Reference Number: EMA/168402/2014 Summary:

Product- or Population-Specific Considerations II: biological medicinal products

Draft guideline on good pharmacovigilance practices (GVP) - Product- or population-specific considerations IV: paediatric population

Draft: consultation closed Consultation dates: 02/08/2017 to 13/10/2017 Reference Number: EMA/572054/2016 Summary:

The paediatric population is defined in the European Union (EU) as that part of the population aged between birth and 18 years. The paediatric population encompasses several subsets.

Draft guideline on good pharmacovigilance practices: Annex I - Definitions

Draft: consultation closed Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/876333/2011 Summary:

This document contains definitions used in the good pharmacovigilance practice (GVP) modules.

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

Draft: consultation closed Consultation dates: 15/12/2015 to 29/02/2016 Reference Number: EMA/36988/2013 Rev. 1 Summary:

Annex II – Templates: Direct Healthcare Professional Communication (DHPC)

Draft guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)

Draft: consultation closed Consultation dates: 15/12/2015 to 29/02/2016 Reference Number: EMA/334164/2015 Summary:

Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)

Specific privacy statement: Public consultation of good pharmacovigilance practices (2012-2019)

Reference Number: EMA/118632/2012

Comments received during public consultation

General comments received from public consultation on good pharmacovigilance practices

Reference Number: EMA/428590/2012

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module I – Pharmacovigilance systems and their quality systems

Reference Number: EMA/428811/2012

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module II – Pharmacovigilance system master file

Reference Number: EMA/428821/2012

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module III – Pharmacovigilance inspections

Reference Number: EMA/806339/2012

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module IV – Pharmacovigilance audits

Reference Number: EMA/806364/2012

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module V – Risk management systems

Reference Number: EMA/428848/2012

Comments received from public consultation on good pharmacovigilance practices (GVP): Module V – Risk management systems (Rev. 2)

Reference Number: EMA/164711/2017

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module VI – Management and reporting of adverse reactions to medicinal products

Reference Number: EMA/428850/2012

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)

Reference Number: EMA/540396/2014

Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VI – Management and reporting of adverse reactions to medicinal products (EMA/873138/2011 Rev. 2)

Reference Number: EMA/847133/2016 Summary:

GVP Module VI – Management and reporting of adverse reactions to

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

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module VII – Periodic safety update report

Reference Number: EMA/428915/2012

Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VII – Periodic safety update report (Rev 1)

Reference Number: EMA/646427/2013

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module VIII – Post-authorisation safety studies

Reference Number: EMA/428922/2012

Comments received from public consultation on good pharmacovigilance practices (GVP) - GVP Module VIII – Post-authorisation safety studies (Rev. 2) (EMA/813938/2011)

Reference Number: EMA/710492/2015 Summary:

Comments received from public consultation on good

pharmacovigilance practices (GVP) - GVP Module VIII – Post-authorisation safety studies (Rev. 2) (EMA/813938/2011)

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 (Re...

Reference Number: EMA/710507/2015 Summary:

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)

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module IX – Signal management

Reference Number: EMA/428835/2012

Comments received from public consultation on good pharmacovigilance practices (GVP): Module IX – Signal management (Rev. 1)

Reference Number: EMA/847158/2016

Comments received from public consultation on good pharmacovigilance practices (GVP): Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions

Reference Number: EMA/647795/2017

Comments received from public consultation on good pharmacovigilance practices (GVP) module X – Additional monitoring

Reference Number: EMA/239763/2013

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP module XV – Safety communication

Reference Number: EMA/35763/2013

Comments received from public consultation on good pharmacovigilance practices (GVP): Module XV – Safety communication (Rev. 1)

Reference Number: EMA/646647/2017

Comments received from public consultation on good pharmacovigilance practices: GVP module XVI - Risk minimisation measures - Selection of tools and effectiveness indicators

Reference Number: EMA/72273/2014

Comments received from public consultation on good pharmacovigilance practices: GVP module XVI - Risk minimisation measures (Rev. 3)

Reference Number: EMA/341696/2024

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP Module XVI Addendum I – Educational materials

Reference Number: EMA/772528/2015 Summary:

The draft of this module was released for public consultation between 27 April and 30 June 2015. The

module has been revised, taking the comments received into account.

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP Module XVI Addendum III (renumbered to Addendum I after finalisation) - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures

Reference Number: EMA/270864/2025

Comments received from public consultation on good pharmacovigilance practices: GVP Module XVI Addendum II - Methods for effectiveness evaluation of risk minimisation measures

Reference Number: EMA/341741/2024

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP - Product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases

Reference Number: EMA/756032/2013

Comments received from public consultation on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products

Reference Number: EMA/172711/2016

Comments received from public consultation on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations IV: Paediatric population

Reference Number: EMA/703506/2018

Comments received from public consultation on good pharmacovigilance practices (GVP): GVP annex I – Definitions

Reference Number: EMA/428732/2012

Comments received from public consultation on good pharmacovigilance practices (GVP): Annex II – Templates: Communication Plan for Direct Healthcare Professional Communication (CP DHPC)

Reference Number: EMA/647372/2017

Versions of GVP chapters with tracked changes

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

Reference Number: EMA/816573/2011

Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections with tracked changes

Reference Number: EMA/119871/2012

Guideline on good pharmacovigilance practices: Module IV – Pharmacovigilance audits with tracked changes

Consultation dates: 26/07/2012 to 21/09/2012 Reference Number: EMA/228028/2012

Guideline on good pharmacovigilance practices: Module V – Risk management systems with tracked changes (Rev. 1)

Reference Number: EMA/838713/2011 Rev 1

Guideline on good pharmacovigilance practices: Module V – Risk management systems with tracked changes (Rev. 2)

Reference Number: EMA/838713/2011

Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products with tracked changes (Rev 1)

Guideline on good pharmacovigilance practices (GVP) - Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products with tracked changes (Rev. 2)

Reference Number: EMA/873138/2011 Summary:

Post public consultation with track changes

Guideline on good pharmacovigilance practices: Module VII – Periodic safety update report with tracked changes

Reference Number: EMA/816292/2011

Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies with tracked changes (Rev. 2)

Reference Number: EMA/813938/2011 Summary:

Track-change version following public consultation - Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR) include provisions for post-authorisation safety studies applicable in the European Union (EU).

A post-authorisation safety study (PASS) is defined in DIR Art 1(15) as any study relating to an authorised medicinal product conducted with the aim of identifying, characterising or quantifying a safety hazard, confirming the safety profile of the medicinal product, or of measuring the effectiveness of risk management measures.

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

Reference 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 with tracked chang...

Reference Number: EMA/395730/2012 Summary:

Track-change version following public consultation - This Addendum provides additional information on legal requirements (identifiable by the modal verb “shall”) and recommendations (identifiable by the modal verb “should”) for the submission of study protocols, progress reports and final study reports of non-interventional post-authorisation safety studies (PASS) to national competent authorities and the Agency. It also provides additional information as regards the registration of non-interventional PASS in the EU PAS Register.

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

Reference Number: EMA/827661/2011

Guideline on good pharmacovigilance practices: Module IX Addendum I – Methodological aspects of signal detection from spontaneous reports of suspected adverse reactions with tracked changes

Reference Number: EMA/209012/2015

Guideline on good pharmacovigilance practices: Module X – Additional monitoring with tracked changes

Reference Number: EMA/237329/2013

Guideline on good pharmacovigilance practices: Module XV – Safety communication with tracked changes

Reference Number: EMA/35829/2013

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

Reference Number: EMA/118465/2012

Guideline on good pharmacovigilance practices: Module XVI– Risk minimisation measures - Selection of tools and effectiveness indicators with tracked changes

Reference Number: EMA/204715/2012

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

Reference Number: EMA/204715/2012

Guideline on good pharmacovigilance practices: Module XVI– Risk minimisation measures - Selection of tools and effectiveness indicators with tracked changes (Rev.3)

Reference Number: EMA/204715/2012

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

Reference Number: EMA/61341/2015 Summary:

Module XVI Addendum I – Educational materials (post-consultation with track-changes)

Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I – Risk minimisation measures for medicinal products with embryo-fetal risks with tracked changes

Reference Number: EMA/608947/2021

Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum II –Methods for evaluating effectiveness of risk minimisation measures with tracked changes

Reference Number: EMA/419982/2019

Guideline on good pharmacovigilance practices (GVP) product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases with tracked changes

Reference Number: EMA/488220/2012 Summary:

Guideline on good pharmacovigilance practices (GVP) product- or population-specific considerations I: Vaccines for prophylaxis against infectious diseases - Track-change version following public consultation

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

Reference Number: EMA/168402/2014

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

Reference Number: EMA/572054/2016

Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev. 5) with tracked changes

Reference Number: EMA/876333/2011

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

Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (superseded)

Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/816573/2011

Guideline on good pharmacovigilance practices: Module II – Pharmacovigilance system master file (Rev.1) (superseded)

Reference Number: EMA/213497/2017

Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections (superseded)

Consultation dates: 27/06/2012 to 24/08/2012 Reference Number: EMA/119871/2012 Summary:

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: Module IV – Pharmacovigilance audits (superseded)

Consultation dates: 26/07/2012 to 21/09/2012 Reference Number: EMA/228028/2012

Guideline on good pharmacovigilance practices: Module V – Risk management systems (superseded)

Reference Number: EMA/838713/2011 Rev 1

Guideline on good pharmacovigilance practices: Module V – Risk management systems (Rev.1) (superseded)

Reference Number: EMA/838713/2011

Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (superseded)

Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/873138/2011

Guideline on good pharmacovigilance practices: Module VI – Management and reporting of adverse reactions to medicinal products (Rev. 1) (superseded)

Reference Number: EMA/873138/2011 Rev. 1 Summary:

This Module of GVP addresses the legal requirements detailed in Title IX of Directive 2001/83/EC [DIR] and chapter 3 of Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and reporting of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU). Recommendations regarding the reporting of emerging safety issues or of suspected adverse reactions occurring in special situations are also presented in this Module.

Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report (superseded)

Reference Number: EMA/816292/2011 superseded

Guideline on good pharmacovigilance practices: Module VIII – Post-authorisation safety studies (superseded)

Consultation dates: 21/02/2012 to 18/04/2012 Reference Number: EMA/813938/2011

Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 1) (superseded)

Reference Number: EMA/813938/2011 Summary:

Guideline on good pharmacovigilance practices (GVP) - Module VIII – Post-authorisation safety studies (Rev. 1) - Superseded

Guideline on good pharmacovigilance practices (GVP): Module VIII – Post-authorisation safety studies (Rev. 2) (superseded)

Reference 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. 2)

Adopted Reference Number: EMA/395730/2012 Rev. 2 Legal effective date: 09/08/2016

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)

Reference Number: EMA/395730/2012 Summary:

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

Guideline on good pharmacovigilance practices: Module IX – Signal management (superseded)

Reference Number: EMA/827661/2011

Guideline on good pharmacovigilance practices (GVP): Module XV – Safety communication (superseded)

Reference Number: EMA/118465/2012

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

Reference Number: EMA/204715/2012

Guideline on good pharmacovigilance practices: Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators (Rev. 1) (superseded)

Reference Number: EMA/204715/2012

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

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

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

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

Module XVI Addendum I – Educational materials

Guidelines on good pharmacovigilance practices: Annex I - Definitions (Rev 1) (superseded)

Reference Number: EMA/876333/2011 Rev. 1

Guideline on good pharmacovigilance practices: Annex I - Definitions (Rev 2) (superseded)

Reference Number: EMA/876333/2011 Rev 2

Guideline on good pharmacovigilance practices (GVP): Annex I - Definitions (Rev. 3) (superseded)

Reference Number: EMA/876333/2011 Summary:

This revision includes amendments of definitions of missing information (including its explanatory note) and risk minimisation activity in accordance with revision 1 of GVP Module V.

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

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

Guideline on good pharmacovigilance practices (GVP): Annex II – Templates: Direct Healthcare Professional Communication (DHPC) (superseded)

Reference Number: EMA/36988/2013