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

Draft GVP chapters and annexes for closed public consultations

Comments received during public consultation

Final versions of GVP chapters with tracked changes

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

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