Europe
The CMDh has agreed to remove the requirement to submit a cover letter for Type IA and Type IAin variation applications. This change took effect on 1 July 2026.
To reflect this update, several guidance documents have been revised, including:
- Requirements on submissions for variations and renewals within mutual recognition procedure (MRP) and national procedures (clean / tracked)
- CMDh Best Practice Guide (BPG) on the use of the electronic Common Technical Document (eCTD) in the MRP and Decentralised Procedures (DCP) (clean / tracked)
- Cover letter for variation applications in MRP (clean / tracked)
- Questions and answers on variations (clean / tracked)
- Chapter 1 – CMDh BPG for the allocation of the MRP variation number for Type I notifications, Type II variations, grouping and worksharing (clean / tracked)
- Chapter 3 – CMDh BPG for the processing of Type IA minor variations (notifications) in MRP (clean / tracked)
- Chapter 6 – CMDh BPG for the processing of grouped applications in MRP (clean / tracked)