Spring Intro 2023

03/03/2023

Mutual Recognition Procedure (MRP)

● Aim at facilitating access to single market through mutual recognition i.e. assessment in one MS (the Reference Member State, RMS) should be recognised by Concerned Member States (CMS) – UNLESS the product presents a potential serious risk to public health ● Must be used for applications for medicinal products in more than one Member State (other than those falling within the scope of the Centralised Procedure) ● To be eligible, a medicinal product must have already received a marketing authorisation in at least one Member State at time of application (RMS) ● Application may then be submitted to one or more Member States (CMS) ● Application must be identical in all involved Member States

The Organisation for Professionals in Regulatory Affairs

15

Decentralised Procedure (DCP)

● Introduced by the review of the 2001 Medicines Legislation ● Product does not have a Marketing Authorisation ● Submit to all EU countries to be involved in the procedure (CMS) ● Choose one national regulatory agency to act as RMS ● Initial ‘national’ approval within 120 days ● RMS prepares Assessment Report based on Consolidated Dossier ● Sub sequent approval in CMS within a further 90 days

The Organisation for Professionals in Regulatory Affairs

16