Current issue of “RMS NEWS”
NEWSTICKER 30.09.2024
- 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:
- 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
