Q&A: Article 20 pharmacovigilance procedures

This page lists questions that stakeholders, in particular marketing authorisation holders (MAHs), may have on an Article 20 procedure resulting from the evaluation of data from pharmacovigilance activities.

It provides an overview of the European Medicines Agency's (the Agency) practical and operational aspects with regards to the handling of Article 20 pharmacovigilance procedures. Revised topics are marked 'New' or 'Rev.' on publication.

A PDF version of these questions and answers is available:

These questions and answers are for guidance only, without prejudice to legal and regulatory interpretation that might be provided in future updates of the rules governing medicinal products in the European Union, volume 2, notice to applicants.

Initiation of an Article 20 pharmacovigilance procedure

During the assessment

Pharmacovigilance Risk Assessment Committee (PRAC) Recommendation

Committee for Medicinal Products for Human Use (CHMP) opinion

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