The updated Annexes to the Roadmap are being published as they become available to reflect further details on the practical implementation steps. Annex 1 to the HMA eSubmission Roadmap on the implementation of eCTD version 4.0 and Annex 2 to the HMA eSubmission Roadmap on the implementation of mandatory use of eCTD format for Human [...]
Updated version 2.1 of the eSubmission roadmap published The updated version 2.1 of the eSubmission roadmap has been endorsed by HMA at their February meeting and has now been published
Common Repository (User Interface and API) is now extended to include the following types of submissions related to procedures for Human Medicinal Products: Signal Detection, PASS 107 NAPs, Work share NAPs and Ancillary products for new submissions from the 8th of March 2018 onwards. This will be followed by a transitional period of 6-9 months, [...]
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.