🧾 CMDh — Coordination Group for Mutual Recognition and Decentralised Procedures (Human)

CMDh issued updated guidance covering the management of variations, national requirements, and harmonisation between mutual-recognition and decentralised procedures.

What This Means for You:
Regulatory teams preparing MRP/DCP submissions should ensure their variation procedures reflect CMDh’s latest recommendations. Include updated module 1 documentation in both EU and UK versions of the eCTD.