CRED ERP 25

2. Overview of the procedures and key definitions Both the Decentralised and the Mutual Recognition Procedures are based on the recognition of an assessment performed by a single EU National Competent Authority (the RMS) by subsequent review by other EU Member State National Competent Authorities (CMS) for national approval.

These procedures are not applicable for products falling under mandatory scope of the Centralised Procedure (CP).

Decentralised Procedure • The DCP is a registration path allowing the Applicant to obtain National Marketing Authorisations simultaneously in two or more EU Member States. Mutual Recognition Procedure • This procedure is based on the mutual recognition by concerned Member State(s) of a national marketing authorisation granted by the Reference Member State.

Key Authority Stakeholders

The Reference Member State (RMS) The RMS evaluates the Marketing Authorisation Application (MAA) dossier and prepares the assessment report. The Concerned Member States in Mutual Recognition Procedure (and Decentralised Procedure) should then base their position on this assessment report. A Reference Member State has an essential role in the MRP (and DCP) procedure; the Reference Member State acts as a scientific assessor of the documentation, as a regulatory advisor to the applicant, and as a moderator in the discussion between the applicant and the Concerned Member State(s). The Concerned Member State(s) This is one or more Member State within the DCP (or MRP) where the Applicant requests marketing authorisation in their country. If a Concerned Member State is requested to recognise a marketing authorisation granted or an application assessed by the Reference Member State it can raise grounds that the medicinal product presents a potential serious risk to public health. Such grounds would have to be fully justified in order to ensure that they do not act as an indirect and artificial hindrance to the free movement of goods. Otherwise, they would accept the MA issuing a license for the medicinal product to be placed on the market in that Member State.