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 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

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

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

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

The final revised versions of all GVP documents listed below are currently scheduled to be released in Q1 2023.

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