Europe – PRAC recommendations on signals : adopted at the 14-17 April 2020 PRAC meeting

This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 14-17 April 2020 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]2 reference numbers).

PRAC recommendations to provide supplementary information are directly actionable by the concerned marketing authorisation holders (MAHs). PRAC recommendations for regulatory action (e.g. amendment of the product information) are submitted to the Committee for Medicinal Products for Human Use (CHMP) for endorsement when the signal concerns Centrally Authorised Products (CAPs), and to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for information in the case of Nationally Authorised Products (NAPs). Thereafter, MAHs are expected to take action according to the PRAC recommendations.

When appropriate, the PRAC may also recommend the conduct of additional analyses by the Agency or Member States…