RMS NEWS

Assignment scheme

Current Slotmatrix

NEWSTICKER 30.06.2024

RECENT COMMITTEE NEWS

Medicinal products containing estragole as an active substance or excipient. The CMDh reminds marketing authorisation holders/registration holders of medicinal products/(traditional) herbal medicinal products ((T)HMPs) containing plants or their preparations containing estragole either as an active substance or as an excipient to check whether their medicinal products comply with the guidance published by the HMPC. These can be found on the EMA website. All marketing authorisation holders/registration holders of estragole-containing medicinal products are requested to consider the publication on the BASG website and, if necessary, to take appropriate measures.

Request form template for MRP/RUP. The CMDh agreed to an update of the request form for MRP/RUPs. The updated template can be found on the CMDh website and on the BASG website.

Data requirements for marketing authorisation applications in MRP/DCPs. The CMDh has updated the document "Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers" regarding the requirements of some Member States and published it on the CMDh website.

Active Substance Master File Worksharing. In January 2024, the CMDh approved an update to the document "The worksharing procedure for the assessment of Active Substance Master File (ASMF)", which was created by the Working Group on ASMF procedures. The document has been revised based on the experience gained since the procedure was introduced. The main change is that already approved ASMFs (with an assessment history of at least 2 years) can be included in the ASMF worksharing under certain conditions. The application form for the EU ASMF number will be updated accordingly. The corresponding guidance document has now been adopted by all relevant groups and is published on the CMDh website.

Q&A on MDR and IVDR updated. The CMDh, in collaboration with the EMA and the European Commission, has agreed an update of the joint EMA and CMDh Q&A for applicants, marketing authorisation holders and notified bodies in relation to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations (Regulations (EU) 2017/745 and (EU) 2017/746). The main objectives of this update are to take into account the experience gained so far in the implementation of the MDR (in particular Article 117) and the IVDR. The updated Q&A document has been published on the EMA website and linked on the CMDh website under "Questions & Answers".

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CMDh (Press releases)

Assignment scheme

Current Slotmatrix

NEWSTICKER 31.03.2024

RECENT COMMITTEE NEWS

CMDh Best Practice Guide on Multilingual Packaging. The CMDh agreed to update the best practice guide for multilingual packaging. Guidance was added on how to create an "EU full/reduced harmonised labelling text" in RUP and Line Extension procedures; guidance on how to change the MS cluster if the "EU reduced harmonised text" is already approved; and guidance on how an already approved "EU reduced harmonised text" is to be changed. The updated document has been published on the CMDh website at this link.

MRP/DCP statistics for 2023. The CMDh has presented its annual statistics on DC/MR procedures for 2023 according to the CTS database. In 2023, Austria as RMS was in 7th place for finalised procedures for human medicinal products! Thank you very much for your trust - we look forward to continuing to be your competent and reliable partner in marketing authorization procedures at European level!

Procedural Advice on Zero Day MR procedures. The CMDh agreed on a new procedural advice on Zero Day MR procedures. The Zero Day procedure is a mutual recognition procedure with a shortened timetable that can be initiated in exceptional cases to mitigate shortages or problems with access to critical medicinal products with the agreement of the Member States concerned. The Procedural Advice contains information on the preparations prior to the initiation of the procedure, the requirements for the dossier and the respective procedural steps and will be published on the CMDh website under this link.

On the BASG website you will find information on the requirements for day 0 repeat use procedures with Austria as RMS.

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CMDh (Press releases)

NEWSTICKER 31.01.2024

RECENT COMMITTEE NEWS

Update Q&A Medical Devices. The CMDh, in collaboration with EMA and the European Commission, has agreed on an update of the joint EMA/CMDh Q&As on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746).

It was clarified that for MRPs or RUPs, the previously assessed documentation under the MDD for existing products can be accepted if there are no product-related significant changes to the integral DDC (drug-device combination) approved in the RMS since the entry into force of the MDR. A further, more comprehensive update of the questions and answers is currently in progress and will be published in the near future.

Data to be submitted for variations/renewals. The CMDh has revised the guidance document Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers with regard to the data to be submitted. The update takes into account the new standard renewal procedure, which was introduced in February 2023 and specifies whether the requirements for a renewal, a variation or both apply. It also lists those Member States that require a full documentation in standard renewal procedures under their national legislation. The existing national requirements have been reviewed by the Member States and reduced as far as possible.

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CMDh (Press releases)

NEWSTICKER 31.10.2023

RECENT COMMITTEE NEWS

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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CMDh (Press releases)

NEWSTICKER 30.06.2023

RECENT COMMITTEE NEWS

Update Renewal Documents. Following the update of the „Best practice guide on the processing of renewals in the mutual recognition and decentralised procedures“ by the CMDh, the following guidance documents have now also been updated accordingly with regard to the new simplified standard renewal procedure.

CMDh procedural advice on common grounds seen for delaying D0 renewals
Member State agreement upon conditions under which the RMS can start renewals
Recommendations on informed consent applications in MRP and DCP
Template for request for MRP/RUP
Template for end of renewal procedure
Questions & Answers on renewals
End of Procedure in MRP/R

The updated documents have been published on the CMDh-Website.

EMA COVID-19 Status. The EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully managing the unprecedented operational challenges of the pandemic.

While the temporary measures put in place to manage the COVID-19 pandemic are no longer required, resourcing across the European medicines regulatory network remains a major challenge. CMDh will therefore continue to work closely with the EMA and the Heads of Medicines Agencies from the Member State to identify and implement sustainable solutions.

Update RMS request form for DCP. The CMDh has agreed on an update of the RMS request form for DC procedures. The use of the form will become mandatory as of 1 September 2023, but it can already be used before that date on a voluntary basis. The updated request form will be published here on the website of the CMDh.

IMPORTANT LINKS

CMDh (Press releases)

NEWSTICKER 31.03.2023

RECENT COMMITTEE NEWS

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 9^th in finalized procedures for human medicinal products and 4^th 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 rms@basg.gv.at 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.

IMPORTANT LINKS

CMDh (Press releases)