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 two more considerations chapters as follows:

Chapter number Preliminary chapter title Date of release for public consultation
P III Pregnancy and breast-feeding Q1/Q2 2019
P V Geriatric population To be announced

Archives of documents

Final GVP modules

Final GVP product- or population-specific considerations

Final GVP annex II - Templates

For other templates developed outside the GVP process, see:

Final GVP annex III - Other pharmacovigilance guidance

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

Draft GVP chapters and annexes for public consultation

There are no documents published in this section.

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