Questions and answers: Article 30 referral procedures

This page lists questions that stakeholders, particularly marketing authorisation holders (MAHs), may have on Article 30 referral procedures.

It provides an overview of the European medicines Agency's practical and operational aspects with regards to handling of Article 30 referral 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 Article 30 referral

During the assessment

Committee for Medicinal Products for Human Use (CHMP) opinion

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