Current issue of “RMS NEWS”

messages in brief | 30/04/2021

NEWSTICKER 30.04.2021

RECENT COMMITTEE NEWS

MRP/DCP Statistics 2020. The CMDh presented its annual statistics on DC/MR procedures for 2020 according to the CTS database. In 2020, Austria ranked 7^th as RMS for finalised procedures for human medicinal products and 6^th for started procedures. Thank you very much for your trust - we are very pleased to be able to continue to be your competent and reliable partner in marketing authorisation procedures at the European level! We would like to take this opportunity to remind you that slot requests can also be submitted via our eService portal. This information can now also be found in the corresponding CMDh document on slot requests!

BREXIT Update Q&A. The CMDh agreed an update of its Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP to provide clarification on MRP/RUPs for IE, CY, MT and/or UK(NI) from procedures finalised in 2020 and containing both EEA/UK(NI) and UK(GB) batch release sites/batch control sites in their dossiers. The updated document will be published on the CMDh website under “Brexit”.

Summary of CMDh activities in 2020. In the spirit of transparency, the CMDh has prepared a summary of the main activities carried out in 2020 by the CMDh and its working groups. A list of all new or revised CMDh documents published by the CMDh in 2020 is attached to this report as an annex and can be found at this link on the CMDh website.

Update Guidance document Applicant's response document in MRP and DCP. The CMDh has clarified in the revised version of the Guidance document on the Applicant's response document in MRP and DCP for MAAs that an updated version of the electronic application form must be submitted with the responses each time there are changes in Module 3 and 1.2. The current revision of the document is published at this link on the CMDh website.