Questions and answers: Article 31 pharmacovigilance referrals

This guidance addresses a number of questions which stakeholders, in particular marketing authorisation holders (MAHs), may have on an Article 31 referral resulting from the evaluation of data from pharmacovigilance activities.

It provides an overview of the Agency's practical and operational aspects with regards to the handling of Article 31 pharmacovigilance referral procedures.

A PDF version of these questions and answers is available:

The integrated PDF version has been created for printing purposes only. Please refer to the individual questions and answers as published in the referral procedures guidance for access to the hyperlinked information.

Questions and answers are being updated continuously, and will be marked by “New” or “Rev.” with the relevant date upon publication.

It should be highlighted that these questions and answers have been produced for guidance only without prejudice to legal and regulatory interpretation which might be provided in future updates of the notice to applicants. They should be read in conjunction with Directive 2001/83/EC.

Initiation of an Article 31 pharmacovigilance referral procedure

During the assessment

PRAC recommendation

CHMP opinion/CMDh position/agreement

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