Current issue of “RMS NEWS” New
**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
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
