Current issue of “RMS NEWS” New
- RECENT COMMITTEE NEWS
Deletion of the requirement to submit cover letters for Type IA variations. As of 1 July 2026, the requirement to submit a cover letter for Type IA variations will be removed. The following guidance documents have been updated accordingly and will be published on the CMDh website:
- Requirements on submissions for variations and renewals within MRP and national procedures
- BPG on the use of eCTD in the MRP/DCP
- Cover letter for variation applications in MRP
- Questions and answers on variations
- BPG for the allocation of the MRP variation number for Type I notifications, Type II variations, grouping and worksharing (Chapter 1)
- BPG for the processing of Type IA minor variations (notifications) in MRP (Chapter 3)
- BPG for the processing of grouped applications in MRP (Chapter 6)
Updated version of the electronic Application Form (eAF). The updated version 1.28.0.0 of the MAA eAF is now available on the eAF website to allow applicants and marketing authorisation holders (MAHs) to familiarise themselves with the changes. The main reason for the changes to the form is the alignment of product data with the ISO IDMP model.
The form can be used as of 1 September 2026 for new MAA submissions to the National Competent Authorities (NCAs) within national, MR and DC procedures. From 1 January 2027, the use of the updated form will be mandatory for all new MAA submissions to the NCAs.
Applicants are reminded that the version of the eAF should not be changed during an ongoing procedure.
Update of Questions & Answers on Brexit. The CMDh has agreed on an update of its Post-Brexit Questions & Answers. The information on reference medicinal products authorised in the United Kingdom has been further clarified in the document.
The updated document will be published here on the CMDh website.
Meeting with Interested Parties. In June 2026, the CMDh held a meeting with representatives of Interested Parties and exchanged views on the following topics: the new pharmaceutical legislation (NPL), the CMDh Multi-Annual Workplan, variations, safety label variations, multilingual packs, as well as challenges related to trade names.
All presentations as well as the minutes will be published here on the CMDh website.
- IMPORTANT LINKS
CMDh (Press releases)
CHMP (Committee meeting highlights)
PRAC (Meeting highlights)
List of committees and working parties
