Here you will find interesting news and links to current RMS-relevant topics.

• RECENT COMMITTEE NEWS

Update Procedural Advice on Repeat-Use. The CMDh approved an update of the guidance document “Procedural Advice on Repeat-Use”. The most important change is the alignment with the updated guidance on renewal procedures. The updated document can be found on the CMDh website.

Update Q&A on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746). The CMDh, together with the EMA, has agreed an update to the common questions and answers on the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations. It has been updated that - if a declaration of conformity is not available from the manufacturer of the medical device - in certain cases (for class I medical devices - except Is and Im) the marketing authorisation holder's declaration of compliance with the relevant general safety and performance requirements (GSPRs) of MDR Annex I, can be accepted. The updated document has been published on the EMA website.

Update CMDh SOP on decision-making process for new active substance status or extension of marketing protection/data exclusivity. The CMDh has updated the “CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity” and it has been included in the document that decisions on an additional year of market protection/data exclusivity for new therapeutic indications will be published in a separate document (in addition to the CMDh Minutes). It has also been added how the start of the non-cumulative period of one year of data exclusivity for a new therapeutic indication should be calculated. The updated document can be found on the CMDh website.

Update Assessment Report Templates. The CMDh agreed to update all assessment report templates published on the CMDh website and remove the “Names of the assessors” section; this is also in line with the centralised procedure. The name/contact details of the RMS contact person remain included.

MRP/DCP statistics for 2024. The CMDh has presented its annual statistics on DC/MR procedures for 2024 according to the CTS database. In 2024, Austria as RMS was again in 7^th place for finalised marketing authorisation procedures for human medicinal products and 9^th place for started marketing authorisation procedures! Thank you very much for your trust - we look forward to continuing to be your competent and reliable partner in marketing authorisation procedures at European level!

• IMPORTANT LINKS

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**REMINDER**

Registration in IRIS platform. Since January 2025, registration in IRIS has been mandatory for all lifecycle procedures managed by EMA. It is important to note that nationally or decentrally authorised products may also be affected, e.g. for worksharings with NAPs/MRPs/DCPs and CAPs, single assessments of PSURs, referrals and post-authorisation safety studies. Therefore, please make sure that your company also applies for access to IRIS, even if you do not have any centrally authorised products. You can also find helpful information in this EMA document.

• RECENT COMMITTEE NEWS

Edit function of PMS data for Marketing Authorisation Holders. From the first quarter of 2025, the EMA will introduce write access for Marketing Authorisation Holders in the Product Management Service (PMS), initially via the Product User Interface (PUI) and later via Application Programming Interfaces (API). This functionality is crucial for the monitoring of shortages of medicinal products via the European Shortages Monitoring Platform (ESMP). Further information on the possible data input and the specified timelines can be found in the press release of the CMDh meeting of October 2024.

Amended Variation Regulation. Marketing Authorisation Holders are reminded that the Variation Regulation 1234/2008/EC, as amended, and the corresponding updated guidance documents of the CMDh are applicable as of 1 January 2025 and will apply to all variation applications submitted after this date and to Type IA/IAIN notifications implemented by the MAHs in their internal databases as of this date. Type IA/IAIN variations already implemented in 2024 can still be submitted during 2025 according to the old rules. The corresponding updated documents can be found on the CMDh website.

• IMPORTANT LINKS

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• RECENT COMMITTEE NEWS

New labelling requirements for metered dose inhalers (MDIs) containing fluorinated greenhouse gases (centrally, decentrally and nationally authorised products). Due to the entry into force of Regulation (EU) 2024/573, new labelling requirements for MDIs that use fluorinated greenhouse gases (F-gases) as propellants will apply from 1 January 2025. 

The European Medicines Agency (EMA) published two guidance documents (Q&As and QRD statements for the labelling and the package leaflet) on 19.09.2024: 

The ‘Questions and answers on labelling requirements for centrally authorised metered dose inhalers containing fluorinated greenhouse gases’ explain

• how the regulation impacts MDIs containing F-gases
• how these products are to be labelled
• which regulatory procedures should be taken to fulfil the new requirements.

The supplementary document ‘QRD statements for metered dose inhalers containing fluorinated greenhouse gases’ contains translations of the standard statements into all official EU/EEA languages.

Active Substance Master File worksharing. After completing the revision of the document ‘The worksharing procedure for the assessment of Active Substance Master File (ASMF)’, the CMDh has also updated the corresponding ‘EU ASMF number request form’. The most important change is the request for additional information in order to assess the admissibility of including already approved ASMFs (with an assessment history of at least 2 years) in the ASMF worksharing procedure.

The updated template is published on the CMDh website under ‘CMD Working Parties/Working Groups > Working Group on Active Substance Master File Procedures’.

Environmental Risk Assessment (ERA) in MRPs/RUPs. The CMDh agreed to update the request form for MRPs and RUPs. In order to facilitate the implementation of the updated ERA guideline (legal effective date: 01.09.2024), applicants are requested to confirm that the ERA present in Module 1.6 complies with the current version of the guideline before starting an MRP/RUP. For MRP/RUP applications submitted by 31.03.2025, it is possible to commit to submitting a variation within 3 months of the end of the MRP/RUP if the ERA included in Module 1.6 does not comply with the current version of the guidance document.

The updated template is published on the CMDh website under ‘Templates > MRP/RUP’ and BASG website.

Registration in IRIS platform. From January 2025, registration in IRIS will be mandatory for all lifecycle procedures managed by the EMA. It is important to note that nationally or decentrally authorised products may also be affected, e.g. for worksharings with NAPs/MRPs/DCPs and CAPs, single assessments of PSURs, referrals and post-authorisation safety studies. Therefore, please make sure that your company also applies for access to IRIS in good time, even if you do not have any centralised authorisations.

• IMPORTANT LINKS

CMDh (Press releases)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

List of committees and working parties

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• 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".

• IMPORTANT LINKS

CMDh (Press releases)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

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RMS flyer

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• 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.

• IMPORTANT LINKS

CMDh (Press releases)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

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RMS flyer

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• 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.

• IMPORTANT LINKS

CMDh (Press releases)

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PRAC (Meeting highlights)

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RMS flyer

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• 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.

• IMPORTANT LINKS

CMDh (Press releases)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

List of committees and working parties

RMS flyer

Allocation scheme

Current slot matrix

• 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)

CHMP (Committee meeting highlights)

PRAC (Meeting highlights)

List of committees and working parties

RMS flyer

Allocation scheme

Current slot matrix