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 [...]
Due to planned maintenance of the eSubmission systems on Friday 9 June 2023, between 18:00 and 21:00 no submissions will be processed, therefore avoid sending submissions during this maintenance window. For any further information, please contact Service Desk
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 [...]
An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file for Veterinary submissions (removal of obsolete submission types: extension, var-type1b, var-type2 and vet-psur).
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.
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.8 released to production on the 16th of May 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
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 [...]
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