An error had been detected in the eCTD published validation criteria. The updated version with the correc md5 checksums is available here.

From 23 May 2016 it will be possible to use XML delivery files instead of the existing filenaming conventions for number submission types via eSubmission Gateway/Web Client. We would like to involve industry representatives in the upcoming User Acceptance Testing (UAT) which is planned to take place with human and veterinary industry representatives: o from [...]

MAHs are advised that due to system maintenance work the product refresh for the PSUR Repository will be stopped during the following planned dates, which are currently: 11th March to 18th March 2016 22nd March to 29th March 2016 As a consequence MAHs that make changes to data in Article 57 during these periods will [...]

Version 01.19.0.2 of the eAFs has been made available to fix technical issue related to the locking of the variation form and issues with the availability of the controlled terminologies in all forms. If you have already started to fill in version 1.19.0.1 of the variation form please import the user filled data to the [...]

The ICH M7(R2) Guideline on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” has reached Step 4 of the ICH Process in April 2023.

New versions of the electronic Application Forms (eAF v. 01.19) are now available and can be found here. These versions provide usability improvements to the existing forms and reflect the changes in the NtA application forms as published by the European Commission in September 2015. These versions replace the current version of eAF v. 01.18 [...]

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

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