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

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

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.