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 numberPreliminary chapter titleDate of release for public consultation
P VGeriatric populationTo be announced

GVP modules and considerations are regularly reviewed for revision needs and schedules.

Archives of 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

Final GVP modules

Guideline on good pharmacovigilance practices: Module I – Pharmacovigilance systems and their quality systems

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

Guideline on good pharmacovigilance practices: Module III – Pharmacovigilance inspections

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

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

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

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

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

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

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)

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

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

Guideline on good pharmacovigilance practices: Module X – Additional monitoring

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

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

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

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

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

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

Final GVP annex I - Definitions

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

Final GVP annex II - Templates

Guideline on good pharmacovigilance practices: Annex II – Templates: Cover page of periodic safety update report (PSUR)

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

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

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

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

Overview of comments received on draft note for guidance: EudraVigilance version 7.1 - Processing of safety messages and individual case safety reports (ICSRs)

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

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...

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 ...

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...

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

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 D: Postapproval safety data management - Step 5

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use topic E 2 E: Pharmacovigilance planning - Step 5

ICH guideline E2F on development safety update report - Step 5

Final GVP annex V - Abbreviations

Guideline on good pharmacovigilance practices: Annex V – Abbreviations (Rev. 1)

Public consultations

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

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

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

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

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