As of 15 February 2018 version 1.22 of the four electronic Application Forms (eAFs) are mandatory. Older versions of the forms will no longer be supported.
The CHMP Pharmacovigilance Working Party (PhVWP) was responsible for evaluating and monitoring safety issues for human medicines until 2012; it was then replaced by the Pharmacovigilance Risk Assessment Committee (PRAC) with the entry into force of Directive 2010/84/EU. PhVWP recommendation
PSUR Summaries of Assessment Reports after PSUR Work sharing CMDh lists in alphabetical order according to substance, summaries of evaluation reports. The list is updated once a PSUR procedure has been concluded. CMDh - PSUR Work sharing procedure
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 [...]