Pharmacovigilance: Regulatory and procedural guidance

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This page lists the European Medicines Agency's guidance related to pharmacovigilance.

In the past, the European Commission drew up pharmacovigilance guidelines in accordance with Article 106 of Directive 2001/83/EC of the European Parliament and the Council, known as volume 9A. With the application of the new pharmacovigilance legislation as of July 2012, volume 9A has now been replaced by the good-pharmacovigilance-practice (GVP) guideline, published by the Agency. Where GVP modules have not yet been finalised, and for some transitional measures, the relevant parts of volume 9A of the rules governing medicinal products in the European Union remain the reference.

For more information on transitional measures, see questions and answers on implementation of pharmacovigilance legislation.

Other guidelines not incorporated in volume 9A, as well as current and historical concept papers and draft guidelines under public consultation, are listed below.

Guidance is also available on withdrawn products notification and risk-management plans.

Table of contents

Guidance for marketing-authorisation holders

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Pharmacovigilance practices

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