Medicinal Products

Meeting highlights from the PRAC meeting in October 2016


At the meeting held in October 2016, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) adopted a list of outstanding issues to be addressed by the marketing-authorisation holders within Article-20 procedures for direct-acting antivirals for treatment of hepatitis C and for SGLT2 inhibitors, and within Article-31 referral procedures for factor VIII medicines and modified- and prolonged-release paracetamol medicines. The PRAC continued the review within Article-31 referral procedures for gadolinium-containing contrast agents and retinoid medicines.

The PRAC did not initiate or conclude a referral at this meeting.

The PRAC also focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines.

More information on the PRAC October meeting can be found here.