Good pharmacovigilance practices (GVP)

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.
HumanRegulatory and procedural guidancePharmacovigilance

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. 

A chapter on pharmacovigilance for the use of medicines during pregnancy and breastfeeding has been subject to public consultation and is currently being finalised.

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

Introduction

Final GVP modules

Final GVP product- or population-specific considerations

Final GVP annex I - Definitions

Final GVP annex II - Templates

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:

Final GVP annex IV - International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for pharmacovigilance

Final GVP annex V - Abbreviations

Public consultations

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