CMDh Report – December 2024 Meeting
The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 10-11 December 2024.
AMENDED VARIATION REGULATION
MAHs are reminded that the Variation Regulation 1234/2008/EC, as amended, as well as the correspondingly updated guidance documents by CMDh will become applicable as of 1 January 2025 and have to be regarded for all variation applications submitted after that date and, resp., for type IA/IAIN notifications that are implemented by the MAHs in their internal databases from that date on. Type IA/IAIN notifications already implemented in 2024 may be submitted according to the old rules also during 2025.
TRANSITION OF EMA POST-AUTHORISATION PROCEDURES ON IRIS PLATFORM, TRAINING MATERIALS AND FEEDBACK REQUEST
From January 2025, post-authorisation procedures submitted to the EMA on or after 20 December 2024 will be managed in IRIS. The submissions steps will still be done via the current systems, i.e., Gateway and PSUR repository, while IRIS will be used for procedure management only. Post-authorisation procedures transitioning to IRIS are: Variations; Article 61.3 notifications; Marketing Authorisation (MA) Transfers; Periodic safety update reports (PSUR); Post-authorisation measures (PAM) Annual reassessments; Referrals; Post-authorisation safety study (PASS)/ Postmarketing surveillance studies (PMSS); Line extensions; Renewals.
MEETING WITH REPRESENTATIVES OF INTERESTED PARTIES
The CMDh discussed the CMDh Safety Outcome Survey (SOS) WG, the implementation of the Variation Regulation (Regulation (EU) 2024/1701), the new Regulation on fluorinated greenhouse gases (Regulation (EU) 2024/573), environmental risk assessment, 0-day MR procedures and the key information section (KIS) for the package leaflet.
CMDH PRESIDENCY MEETING UNDER THE HUNGARIAN PRESIDENCY OF THE COUNCIL OF THE EU
The CMDh convened for a Presidency meeting on 3 and 4 December 2024 in Budapest. In the meeting the CMDh discussed, amongst others, topics related to the CMDh multi-annual workplan, artificial intelligence, the slot booking system and the IncreaseNET project.
CHANGE IN THE PRESIDENCY OF THE COUNCIL OF THE EUROPEAN UNION
The December 2024 CMDh meeting was the last one under the Hungarian Presidency of the Council of the European Union. Poland will take over the Presidency in January 2025. Andrzej Czeslawski will be appointed Presidency vice-chairperson of the CMDh during the Polish Presidency of the Council of the European Union.
SAFETY OUTCOME SURVEY (SOS) WORKING GROUP
The WG discussed the preparation of safety summaries for the publication of NAP safety variation outcomes and presented the progress of this initiative to the CMDh.
GUIDANCE ON AMENDED VARIATIONS REGULATION
The CMDh discussed the mandatory worksharing requirement set out in the amended Variations Regulation applicable as of 1 January 2025. The CMDh agreed that a PI update of a generic medicinal product where the MAH of the RefMP is not the same in all MSs could be included in a WS provided that the generic medicinal product can also refer to the harmonised product texts in the MS that does not have the current innovator text. However, no product-specific assessment should be necessary.
The CMDh discussed whether safety updates of the originator can also be implemented for well-stablished use MAs in a worksharing without the requirement for type II C.I.4. variations to submit a full data package to substantiate the change. It was noted that from a regulatory perspective, the possibility of deviating from the requirements for type II C.I.4 variations for WEU MAs is not foreseen due to the lack of reference product. However, in some cases analogous to Q&A 3.23 of the CMDh Questions and Answers on Variations, a limited data package could be acceptable. The CMDh agreed that such proposals should be considered on a case-by-case basis.
It was also discussed how to deal with the implementation of safety updates for more than one MA of the “same” product with different variation classification types applicable (due to different legal basis or different situations regarding the RefMP). It was the CMDh view that a WS procedure should not apply to different variation categories/classifications and that, at least for the adaptation to the texts of the reference marketing authorization, i.e. C.I.2 variations, the (voluntary) upgrade to type II may allow the WS. The inclusion of WEU requests should also be pre-discussed and decided on a case-by-case basis.
MOBILE SCANNING TECHNOLOGIES INCLUDED IN LABELLING AND PL
ES presented the changes proposed to the ‘CMDh position paper on the use of Mobile scanning and other technologies to be included in labelling and package leaflet (PL) in order to provide information about the medicinal product’ and the ‘Annex-2 Template for the Applicant declaration’. MSs were asked to respond to the suggestions in the document . Discussions were still ongoing at QRD level on the need to make explicit reference to the development of platforms by third parties. The CMDh will only finalise the update of the CMDh guidance document, once the QRD discussions are finalised.
IMPLEMENTATION OF THE AMENDED VARIATION REGULATION
The CMDh noted the EC feedback to questions raised in relation to the amended Variation Regulation, specifically in relation to annual reports and possible transition periods.
It was clarified that Type IA variations that have been implemented in 2024 have to be submitted according to the current rules i.e. as a single submission or grouping within 12 months of its implementation. Type IA variations implemented on or after 1 January 2025 should follow the amended Variation Regulation (Regulation (EU) 2024/1701 of 11 March 2024) and are expected to be submitted as an annual update, unless one of the exemptions is applicable and used by the MAH.
It was further clarified that the amended Variation Regulation entered into force in July 2024 which gave about 6 months for preparation for the implementation. Companies were also closely involved in the preparation and consultation procedures before the adoption of the Regulation. Therefore, a transitional period for implementation of the procedures is not expected.
