Useful Information
Pharmacovigilance Risk Assessment Committee (PRAC)
The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency's (EMA) committee responsible for assessing and monitoring the safety of human medicines. The Committee meets once a month. EMA publishes the agendas, minutes and highlights of its plenary meetings.
https://www.ema.europa.eu/en/committees/pharmacovigilance-risk-assessment-committee-prac
CMDh Recomendations
The Co-ordination group for mutual recognition and decentralised procedure provides recomendation on the product labels and potential safety concerns.
https://www.hma.eu/human-medicines/cmdh/product-information/cmdh-recommendations-1.html