CRED 8 Presentations

08/07/2024

Understanding the opportunities and challenges of the MR/DC Procedures MRP/DCP: Definitions

Both the decentralised and the mutual recognition procedures are based on the recognition by national competent authorities of an assessment performed by the authorities of more than one Member State Not Applicable for products falling under mandatory scope of the CP Decentralised Procedure ● The DCP is a registration path allowing the Applicant to obtain simultaneously National Marketing Authorisations 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. The concerned Member State refers to the reference Member State that issued the national marketing authorisation on which the mutual recognition procedure is based

Article 28 of DIRECTIVE 2001/83/EC

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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Understanding the opportunities and challenges of the MR/DC Procedures MRP & DCP: Key Authority Stakeholders

RMS (Reference Member State)

CmDH: Coordination group for Mutual recognition and Decentralised proceduresfor human medicinal products ● Replaced the Mutual Recognition Facilitation Group (MRFG) in 2005 ● Came about as a result of Directive 2004/27/EC ● Mixed responsibilities: procedural, regulatory and scientific ● One representative from each MS, appointed for 3 years (renewable) + observer from EMA and Commission ● CMD(h) Chair appointed for 3 years

● Selected by the Applicant ● Takes the lead and prepares the assessment report (AR) ● Central point between other MSs and Applicant CMS (Concerned Member State) ● Member state where the MAA is submitted in addition to the RMS for the same procedure

The Organisation for Professionals in Regulatory Affairs The Organisationfor Professionals in Regulatory Affairs

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