An Active Substance Master File (ASMF) can be used to replace the documentation for an active substance, required as part of an initial marketing authorisation application (MAA) or subsequent marketing authorisation variation (MAV). Appropriate guidance is given in the CHMP/CVMP guideline on active substance master file procedure. A specific ASMF can be used for multiple [...]
New versions of the 4 electronic Application Forms (eAF v. 1.23.1.0) and the related release notes are now available. This new version is a hotfix release v1.23.1.0 of the forms and can be used as of today, 28th September 2018. The current versions (v1.23.1.0) of the forms can be used and will fully replace the [...]
Please note that the EMAeSubmission Gateway web UI is being updated to reflect in the field “Submission format” the VNeeS version 2.6 for Pharmaceutical and Immunological products. For the time being, therefore, please submit your applications in VNeeS version2.6 using the submission format 2.5.
The following updated Annexes to the eSubmission Roadmap have been published to reflect further details on the practical implementation steps. Annex 3 to the HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary regulatory submissions, Annex 4 to the HMA eSubmission Roadmap on the replacement of the current PDF electronic application forms [...]
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