Questions and answers: Article 20 non-pharmacovigilance procedures

This page lists questions that stakeholders, particularly marketing-authorisation holders (MAHs), may have on an Article 20 non-pharmacovigilance procedure.

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

A PDF version of these questions and answers is available:

These questions and answers are for guidance only, and should be read in conjunction with the rules governing medicinal products in the European Union, Volume 2A, chapter 3, notice to applicants. Marketing-authorisation holders (MAHs) must in all cases comply with the requirement of EU legislation.

Initiation of an Article 20 non-pharmacovigilance procedure

During the assessment

Committee for Medicinal Products for Human Use (CHMP) opinion

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