Questions and answers: Urgent Union procedures (Article 107i)

This page lists questions that stakeholders, particularly marketing-authorisation holders (MAHs), may have on urgent Union procedures.

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

A PDF version of these questions and answers is available below.

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.

These questions and answers should be read in conjunction with Directive 2001/83/EC, as amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010, without prejudice to the implementation of the changes resulting from Directive 2012/26/EU of the European Parliament and of the Council of 25 October 2012 amending Directive 2001/83/EC as regards pharmacovigilance.

Initiation of the urgent Union procedure

During the assessment

Pharmacovigilance Risk Assessment Committee (PRAC) recommendation

Committee for Medicinal Products for Human Use (CHMP) opinion or Co-ordination Group for Mutual Recognition and Decentralised Procedures (CMDh) position/agreement


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