Current issue of “RMS NEWS”

messages in brief | 31/03/2023


NEWSTICKER 31.03.2023


MRP/DCP statistics from 2022. The CMDh has presented its annual statistics on DC/MR procedures for 2022 according to the CTS database. In 2022, Austria as RMS ranked 9th in finalized procedures for human medicinal products and 4th in started procedures! Thank you for your trust - we are very pleased to continue to be your competent and reliable partner in marketing authorisation procedures at the European level!

BPG Renewals. In the interest of simplifying regulatory processes, the CMDh has agreed to revise the renewal procedure for MR/DC procedures and has updated its Best Practice Guide on the processing of renewals in the Mutual Recognition and Decentralised Procedures accordingly. Since publication, a shortened standard renewal procedure is to be used for the renewal of all authorisations. The duration of this procedure is limited to 30 days and only the cover letter (updated template) and the application form – without attachments – are required for submission. However, it is still possible that additional documentation may be requested by RMS or CMS for national legislative reasons.

An expanded renewal procedure with a time table of 90 days and the submission of the full documentation shall only be used in justified exceptional cases.

The new standard procedure applies to all MRP/DCP renewal applications submitted from the date of publication of the revised BPG (Feb. 2023). Procedures that are already in progress at the time of publication will be finalised under the previous version of the BPG. For applications submitted prior to the date of publication, but procedures not yet started, it is at the discretion of the RMS to determine whether the new or old procedure will apply.

Please contact your case manager or in case you have any questions.


Updated documents. Various CMDh guidance documents have been updated accordingly with regard to the removal of the requirement to submit so-called "dispatch lists". See CMDh press release December 2022 and January 2023.

Furthermore, the CMDh agreed to update the CMDh position paper regarding applicant's request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP. With the update, the CMDh provides conditions for the inclusion of new CMS during an ongoing DCP (if there is no ongoing duplicate application with the same CMS) to prevent or address any shortages.

The CMDh also agreed to update the Applicant's (joint) response template - responses to the question raised by RMS and CMSs. A new section has been added where the applicant can submit information on proposed changes in the manufacturing chain (to keep the RMS informed) and/or in the submitted GMP documents, including submission of newer versions. Use of the template is already mandatory for all pending responses as of February 1, 2023.


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