Safety referral procedures clarified.

Two types of referrals are available for the purpose of harmonising pharmacovigilance decisions across the EU: the urgent procedure and the "normal" procedure. In both cases, the Pharmacovigilance Risk Assessment Committee (PRAC) issues a recommendation that the marketing authorisation committees concerned must take into account when formulating their opinions. If Member States disagree in their decisions, a final referral is available, although it lacks transparency. The European Commission's final decision is binding on all Member States.