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 [...]

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 [...]

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

Due to essential maintenance, PSUR will be unavailable on Tuesday 11 April 2023 between 18:00 and 20:30 (CET). For any questions or concerns, please log a ticket via the EMA Service Desk

Ifosfamide Date of publication: 12/04/2023

The ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) Addendum “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes” have reached Step 4 of the ICH Process on 3 April 2023.

Following the launch of the Human Variation electronic Application Form (eAF) for Centrally Authorised Products (CAPs) on the Product Lifecycle Management (PLM) Portal, we appreciated many users have accessed the PLM Portal to work on variation applications using the new web-form.