01.07.2026.
The CMDh has agreed to delete the requirement to provide cover letters for type IA variations, starting from 1 July 2026.
The following guidance documents have been updated to reflect the change:
- 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)
The guidance documents will be published on the CMDh website under “Procedural Guidance > Variations”, “Procedural Guidance > eSubmissions”, “Templates > Variations” and “Questions and Answers”, respectively.
