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

Please note the eAF PDF is not working as expected (the active substances cannot be selected from the database). Our colleagues are working on fixing the issue and once the eAF PDF will be fully functional, a message will be posted on this page and the users who have raised a related ticket in EMA [...]

We are pleased to inform you the updated PLM (Product Lifecycle Management) Portal web-based electronic Application Form (eAF) for Human medicinal products release timeline is available on the PLM portal Forum at the following link. In addition, we invite PLM Portal users' feedback on the Portal and web-based eAFs through a survey you can find [...]

Levonorgestrel intra-uterine devices (LNG-IUDs) Date of publication: 03/05/2023

Added in May 2023 22 May NEW - 23-25 May agenda 3 May UPDATE - Assessment report template for the nitrosamine risk assessment for the outcome of step 2 – “nitrosamine detected”  UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines UPDATE [...]