Added in June 2023 1 June NEW - April 24-25 minutes

Fluarix Tetra (Influenza virus (inactivated, split) of each of 4 strains (two A subtypes and two B lineages)) End of procedure: 31/03/2023 Date of publication: 02/16/2023

Prazosin End of procedure: 02/04/2023 Date of publication: 02/16/2023

Meeting with Interested Parties - 31 May 2023 Agenda Presentations CMDh - Multilingual Labelling in MRP/DCP CMDh - Renewal improvements CMDh - Availability of updated PI following safety reviews Medicines for Europe Europharm SMC

Meeting with Interested Parties on Variations - 16 May 2022 Presentations AESGP EFPIA EUCOPE Medicines for Europe

Added in June 2023 19 June NEW - 20-21 June CMDh agenda  UPDATE - Best Practice Guide on (1) Introduction of substances/combinations onto the EURD list and setting the initial PSUR DLP and frequency and (2) Assessment of PSURs of products where the EU Reference Date is not yet legally binding 6 June NEW - Agenda for [...]

The PSUR bulletin for the week commencing 29 June 2015 is now available.

The ICH E6(R3) draft Guideline on “Good Clinical Practice (GCP)” has reached Step 2 of the ICH process on 19 May 2023.

We are pleased to announce the third edition of the eAF-PMS newsletter is now available at the following link.

The selection of active substances is now possible and eAF PDF is working as expected. Should you encounter any issues, please raise a ticket in EMA Service Desk