Chapter 6 – CMDh Best Practice Guide: Grouped Applications in Mutual Recognition

This guide explains the process for grouping multiple variations into a single application under the mutual recognition procedure. It includes exemptions for separate applications and rules for combining marketing authorizations involving more than one Reference Member State (RMS).

Key topics covered:

• Introduction and application types
• Allocation of variation procedure numbers
• Validation of applications

The timetable and type of grouped application depend on the most significant variation included, with specific rules for Type IA, Type IB, Type II, and extension applications. Purely national marketing authorizations cannot participate in the “”Lead-RMS”” procedure.

Marketing Authorization Holders (MAHs) must submit a complete application to the RMS and Concerned Member States (CMS), including a cover letter, application form, and supporting documents. For grouped Type IA applications involving multiple RMSs, outcomes will be recorded in the CTS, with partial invalidation reasons noted in the outcome letter.

Source: https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/procedural_guidance/Variations/CMDh_296_2013_Rev.29_2025_02_clean_-_Chapter_6_-_BPG_for_the_Processing_of_Grouped_Applications_in_MRP.pdf

Region: European Union