Current issue of “RMS NEWS”

messages in brief | 31/01/2022


NEWSTICKER 31.01.2022


Best practice guide on Multilingual Packaging. The CMDh has agreed to revise the Best Practice Guide on Multilingual Packaging and has published the updated document on the CMDh website at this link. This includes revisions based on feedback given by Member States and Interested Parties and further clarifications on the practical aspects. The template of the Cover Letter has also been revised and now provides the opportunity for applicants to inform about their interest in participating in the Multilingual Packaging Pilot.

Brexit - Update. On December 17, 2021, the European Commission presented proposals to ensure the long-term supply of medicines from Great Britain to Northern Ireland, and to address existing supply issues in Cyprus, Ireland and Malta. The proposals include a "draft Commission Notice" (C/2021/9668) on the application of the Union’s pharmaceutical acquis in markets that have historically depended on supplies of medicines from or via parts of the United Kingdom other than Northern Ireland, and adopted legislative proposals to amend the relevant provisions, e.g. Directive 2001/83/EC.

The current version of the CMDh Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP refers to Commission Notice C/2021/450. The guidance states that for MR/DC procedures involving Cyprus, Ireland, Malta and Northern Ireland, the continued use of sites in the UK for batch control and release may be permitted on a temporary basis until the end of 2021 under certain conditions, provided that the competent authorities of Cyprus, Ireland, Malta and Northern Ireland approve this for supply to their markets only. The CMDh notes that this period has been extended until 31.12.2022, or until the entry into force of the legislative amendments if this date is before 31.12.2022, in accordance with the conditions set out in the draft Commission Notice C/2021/9668. The CMDh Best Practice Guide will be updated accordingly.

Additionally, question 34 from the current CMDh Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP has been updated; removing the reference that a UK reference medicinal product used in a bioequivalence study finalised before the end of the transition period must be approved via a European procedure.

Update User Guide for eAF. The user guide for the electronic application form for a Marketing Authorisation application has been revised to reflect information related to the new sections of the eAF on medical devices. The updated document has been published on the CMDh website at this link.


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