EMA: Draft rules of procedures on the organisation and conduct of public hearings at the Pharmacovigilance Risk Assessment Committee (PRAC)

The Pharmacovigilance Risk Assessment Committee (PRAC) has the possibility to hold public hearings in the context of safety referral procedures under Article 20 of Regulation (EC) 726/2004, and Article 31 or Article 107i of Directive 2001/83/EC. The Committee takes the decision to hold a public hearing on a case-by-case basis, where the urgency of the matter in question permits and after considering that this is appropriate on justified grounds particularly with regard to the extent and seriousness of the safety concern.