Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 1-3 October 2012

News 05/10/2012

PRAC starts first referral procedure

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) started the first safety review of a medicine under the new European Union (EU) rules on pharmacovigilance at its third meeting from 1 to 3 October 2012.

The safety review concerns codeine-containing medicines when used for post-operative pain relief in children. These medicines are only authorised nationally, at the level of the EU Member States. The PRAC will assess all available information and make a recommendation to the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh). Under the new rules, the group leads on decision-making based on recommendations from the PRAC for nationally authorised medicines. These changes ensure harmonised implementation of safety recommendations across the EU.

A link to more information on this review is available in the table below.

New levels of transparency for safety reviews

The new pharmacovigilance legislation includes an explicit commitment to openness and transparency in the European medicines safety-monitoring system. For EU-wide safety reviews, the Agency now provides more information than ever before at the beginning of the safety review. Information made available to the public for the safety review of codeine-containing medicines includes:

  • an announcement document on the review of codeine-containing medicines;
  • the notification of a referral made by the United Kingdom;
  • the list of questions drawn up by the PRAC to be addressed by the marketing-authorisation holders;
  • the timetable for the procedure.

For an overview of all information available following the meeting of the PRAC, see the table below.


PDF icon Agenda - PRAC draft agenda of meeting 1-3 October 2012

Start of referral procedure

Codeine-containing medicines
Article 31 referral: Codeine-containing medicines

Announcement - Review of codeine-containing medicines started
PDF icon Referral notification
PDF icon PRAC list of questions
PDF icon Timetable for the procedure

How useful was this page?

Add your rating