CMDh Report from October 2024 Meeting
The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 15-16 October 2024.
MULTILINGUAL PACKAGING WORKING GROUP
The WG discussed among others the impact of the new pharma legislation on multilingual packaging (MLP), queries from industry related to the BPG on MLP and potential topics for a further revision of the BPG.
SAFETY OUTCOME SURVEY (SOS) WORKING GROUP
The group discussed questions received with regards to the recently updated Q&A 10 of the CMDh Q&A on Pharmacovigilance Legislation. It was clarified that information in the CMDh minutes aims to support MAHs to submit the appropriate variations. However, the absence of the information on possible relevance of the outcome to other products in the CMDh minutes does not exempt MAHs from their obligation to continuously re-evaluate current scientific knowledge and keep their product information updated.
The WG also discussed the preparation of safety summaries for publication of outcomes of safety variations for NAPs. The WG presented to CMDh some examples of mock-ups of the safety summaries and a short guidance on how to prepare them.
POLISH PRESIDENCY MEETING
PL announced that the next presidency meeting under the Polish presidency of the Council of the European Union will be a Joint CMDh/PRAC meeting to be held in Warsaw on 1-2 April 2025.
MULTI-ANNUAL WORKPLAN 2025
The CMDh discussed the status of some action points in the CMDh’s MAWP to 2025. Member states were asked to review the status of their action items, to consider volunteering as rapporteurs and to also consider new action items for the next MAWP. Member states will review the European medicines agencies network strategy (EMANS) to 2028 to align the CMDh MAWP to 2028.
IRIS PLATFORM
The EMA provided the CMDh with an update on the transition to the IRIS platform. As of January 2025, all EMA post-authorisation procedures will be managed through IRIS, including some procedures for non-centrally approved products (MRP/DCP/NAP), i.e. PSURs, referrals and PASS. The CMDh was informed about the training plan and the post-implementation support for the network.
MEDICINE SHORTAGE COMMUNICATIONS (MSCS) – TEMPLATE
The EMA presented a new template and process for Medicine Shortage Communication (MSC). The principle of the process is that communications that concern critical supply or shortages, without an associated Q/S/E issue, will be endorsed by MSSG (with the new MSC template). CHMP/CMDh will be kept informed of the process. A 6-month pilot for the use of the new template and process has been started.
EU REGULATION ON FLUORINATED GASES (F-GASES)
The Regulation should be enforced by the national environmental agencies. Any requests for flexibility should therefore be addressed to the national environmental agencies or answers be aligned with these agencies.
The CMDh discussed if a declaration template should be agreed and used for the MAH to declare that the figures included, where relevant, in the QRD statements for metered dose inhalers containing fluorinated greenhouse gases are correct and calculations are available on request. The CMDh agreed by majority that such a template would not be needed as the MAH is responsible to ensure this information is correctly stated, but can be used at national level, if considered useful.
Following a request from a MAH, the CMDh agreed that, due to the short timeline for the implementation of the labelling requirements under the EU Regulation on fluorinated gases, initial variation submissions can be processed without mock-ups. The applicant should commit to submit mock-ups, where relevant, when they become available.
It was further agreed that in this case the labelling can be prepared with a revision date of January 2025 (rather than the date of approval), so that the labelling can be prepared as soon as possible without waiting for regulatory approval. The same changes have been agreed by the EMA for the handling of CAPs.
