PRAC begins second referral procedure


The European Medicines Agency’s (PRAC) held its fourth meeting from 29 to 31 October 2012.


Since the first meeting of the PRAC in July 2012, the Committee’s agenda has expanded substantially. At their most recent meeting, PRAC experts evaluated an increasing volume of information on new safety signals generated from European- Union (EU) reporting systems as well as a growing number of updated risk-management plans for certain medicines.


Review of diclofenac-containing medicines started


The second safety review concerns diclofenac-containing medicines in relation to their possible cardiovascular risks. It follows a recent review of scientific studies by the Agency’s (CHMP) on the cardiovascular safety of non-selective non-steroidal anti-inflammatory drugs (NSAIDs). More information on the review of diclofenac started by the PRAC is available in the table below.


Article 31 referrals


The review of diclofenac-containing medicines is the second safety review of a medicine under the new EU rules on pharmacovigilance. It has been initiated at the request of the United Kingdom (UK) medicines agency, under Article 31 of Directive 2001/83/EC. This procedure is used to address public-health concerns with medicines that are only authorised nationally, at the level of EU Member States, such as diclofenac.


The PRAC will now assess all available information and make a recommendation to the Coordination Group for Mutual Recognition and Decentralised Procedures – HumanExternal link icon (CMDh). Under the new rules, the coordination 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.


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 diclofenac-containing medicines includes:


  • an announcement document on the review of diclofenac-containing medicines;
  • the notification of a referral made by the UK;
  • 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.


Minutes from the third PRAC meeting, which took place from 1 to 3 October 2012, will be published on Tuesday 6 November 2012.


Posted on the EMA website on 31 Oct 2012