Resources - PRAC Communication

The Pharmacovigilance Risk Assessment Committee

The Pharmacovigilance Risk Assessment Committee (PRAC) is one of the scientific committees established at the European Medicines Agency (EMA) in London.

This Committee was set up in July 2012 within the frame of the new EU pharmacovigilance legislation, and the ISoP Past President Hervé Le Louet is coopted member by the European Commission of the committee.

The PRAC deals mandatorily with all drug safety issues that might require a change in drug licences or any action to increase the safe use of drugs. The PRAC carries a strong weight within the EU pharmacovigilance system and meets every month. You will have access to ‘Recommendations’, i.e. decisions, given by the PRAC and agendas and minutes of its meetings as well.


Following a review, the European Medicines Agency’s experts in medicines safety have recommended that modified- or prolonged-release paracetamol products (designed to release paracetamol slowly over a longer period than the usual immediate-release products) should be suspended from marketing. This is in view of the risks to patients from the complex way these medicines release paracetamol into the body after an overdose.

The press release is available by clicking here


Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC). The European Medicines Agency has launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC). The rules of procedure describe the process and practical arrangements for the preparation, conduct and follow-up of public hearings. You are kindly invited to review the proposed draft rules and send your comments to the Agency.

Draft document click here (consultation closed)


The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) confirms that benefits of all combined hormonal contraceptives (CHCs) continue to outweigh risks.

To view the PRAC recommendations click here