Member: Vacant Alternate: Mathilde Geynet-Kovacs Agence nationale de sécurité du médicament et des produits de santé (ANSM) 143-147 Bvd Anatole France FR-93285 SAINT-DENIS CEDEX

New version 1.24.0.1 of all four eAFs is now available to allow the users a short transitional period before the start of the mandatory use of the form. The changes in this version of the forms (v1.24.0.1) relate to the Member State, OMS and Country fields in all 4 forms and the changes are implemented [...]

An updated release milestone plan and release schedule for the electronic Application Forms (eAF) are now available. Version 1.24.0.0 of all the 4 electronic Application Forms (eAFs) is planned for release in September 2020 with a 2 month transitional period, and mandatory use from November 2020. The release v1.24.0.0 will provide a major change into [...]

Users should be aware that due to essential maintenance work on EMA's infrastructure, most of EMA's computer applications, including most eSubmission systems will experience downtime between the hours of 18:00 on Friday, 17th July and 14:00 on Saturday, 18 July 2020. Please note that if you have submission deadline for your procedure on Friday, 17th [...]

Due to planned maintenance, the PSUR Repository (both NCA and Industry portals) will not be available on Saturday, 16 September 2023, between 9:00 and 17:00. For any further information, please contact EMA Service Desk

Essential maintenance work will be carried out to all eSubmission applications as part of EMA's computer application maintenance work this weekend. As a result, eSubmission systems will be intermittently unavailable between 10:00hrs and 13:00hrs of Saturday, 11 July 2020. If you have any questions, please contact the EMA Service Desk.

There is a short delay in the start of the UAT for the eAF v1.24.0.0 - new dates will be communicated very soon. If you wish to participate in the UAT, please register by email with eSubprogofficer@ema.europa.eu

Changes to product information following the outcome of imposed non-interventional post-authorisation safety studies (PASS) can be found on:   for centrally authorised products (CAPs) - the outcomes of imposed non-interventional PASS final study results assessments are published as part of each medicine's European public assessment report (EPAR) and the Decision will be published per product for [...]

An updated version of the eSubmission Gateway XML delivery file user interface is now available. The eSubmission Gateway update has introduced an additional submission unit for PAM submissions and a mandatory selection of yes/no to indicate if a change of MAH is included in a response submission for MAA human and vet. Additionally some minor [...]

A new version of the eSubmission Gateway XML delivery file user interface is now available. Following this release the use of the Formatted Letter template will become obsolete as of 1st January 2020. This will concern all EMA Human and Veterinary submissions (including PSUSA procedures) and after this it will be optional for applicants to [...]