List of European Union reference dates and frequency of submission of periodic safety update reports (PSURs)

List of medicinal products under additional monitoring

List of medicinal products under additional monitoring

Procedural advice for requests for the classification of variations not already listed in Commission Implementing Regulation (EU) 2021/17 or EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62

Timetable: Extension application

EMEA-002024-PIP02-22

EMEA-003051-PIP05-22

Scientific advice and protocol assistance adopted during the CHMP meeting 19-22 February 2024

Minutes of the PRAC meeting on 27-30 November 2023

Minutes of the CAT meeting 17-19 January 2024