Mutual Recognition Procedure

CDISC-Gloss – The EU procedure to be used when a product is already authorized in at least one Member State and the Marketing Authorization Holder wishes to obtain a Marketing

Authorization (MA) for the same product in at least one other Member State. The Member State that has already authorized the product is known as the Reference Member State (RMS). The RMS submits their evaluation of the product to other Member State/s, these are known as Concerned Member State/s (CMS). If the applicant is successful, the CMS will then issue a MA for that product permitting the marketing of that product in their country.

[After Heads of Medicines Agencies (HMA) website Heads of Medicines Agencies: Medicines Approval system (hma.eu)] See also Reference Member State (RMS) and Concerned Member State (CMS).