Please find an updated version of the PLM Portal eAF Guide to Registration here.

An updated version of the Harmonised Technical Guidance for ASMF Submissions in eCTD format and the related Release notes are now available here.

Ramipril/bisoprolol Date of publication: 28/07/2023

An updated version 1.26.0.0 of the veterinary variation eAFs is available starting with 24 July 2023.

Version 1.22 of the electronic Application Forms (eAFs) will become available on 15 December 2017.The release v1.22 will provide integration with OMS from SPOR (Organisational/address data), usability improvements and technical defect fixes. User Acceptance Testing (UAT) is planned to support the release of this next version of the forms. testing by Industry and NCAs will [...]

Imovax Polio SK/W/0002/pdWS/001 End of Procedure: 18/04/2011 Date of Publication: 28/09/2012 HR/W/0001/pdWS/001 End of procedure: 06/06/2023 Date of publication: 28/07/2023

eSubmissions Web User Interface (to create the delivery file) will be unavailable between 07:00 and 09:00 on Friday, 29 September 2017 However, the EMA gateway will remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete. The Common Repository will also be [...]

Archive 2012 - 2020 Acronyms and abbreviations used in the CMDh documents

2023 - January-June - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures

The CMDh, in line with EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA), is phasing out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic (see also EMA/EC/HMA announcement). This follows the end of the COVID-19 [...]