Current issue of “RMS NEWS”

messages in brief | 31/10/2023


NEWSTICKER 31.10.2023


Overview of EU safety assessment outcomes. Marketing authorisation holders are responsible for keeping their product information up to date and adapted to the latest scientific knowledge and recommendations. To facilitate this task, the CMDh has decided to update the CMDh website and now offers under the heading "Product Information" an overview of the results of the EU safety assessments of the various procedures.

Updating the eAF at the end of procedure. The eAF should be the leading document in a procedure and should be updated with each response from an applicant when the information about manufacturers changes during the procedure. The information should be always synchronised with Module 1.2 and Module 3. For the end of procedure (EoP), only the final information in Module 1.2 together with Annex 5.8 is considered. However, the CMDh has found that in many cases, applicants do not reconcile the manufacturer information in the eAF with Module 3.

The RMS and CMS will continue to advise applicants to keep the eAF up to date until the EoP. However, the CMDh has now agreed that - if discrepancies between Module 3 and Module 1.2 occur after the EoP - a variation must be submitted to include/correct the manufacturer information.

The Applicant’s response document in Mutual Recognition and Decentralised procedures for Marketing Authorisation Applications and the User Guide for the eAF have been updated accordingly. Further, a check box has been added to the Applicant's response template to confirm that data has been synchronised between Module 3 and Module 1.2.

Harmonisation of RMP Project (HaRP). As part of the RMP Harmonisation Project (HaRP), the HaRP Peer Review Group has completed 22 new assessment reports, resulting in an agreed harmonised list of safety concerns per active substance. The updated list can be found at this link on the CMDh website.


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