CRED 8 Presentations

01/07/2024

Legal provisions MRP/DCP (1/2)

National applications for the same medicinal product, resulting in national MAs in more than one MS, but European harmonised assessment and outcome!

Legal provisions in Article 28 of Directive 2001/83/EC, only difference in initial phase Both the mutual recognition procedure and the decentralised procedure aim at facilitating access to the market by relying upon the principle of mutual recognition. Not applicable for products falling under the mandatoryscope of centralised procedures

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The Organisation for Professionals in Regulatory Affairs

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Legal provisions MRP/DCP (2/2)

 Mutual recognition procedure (MRP) where the medicinal product has already received in a MS a MA at the time of application (Articles 28.2 and 28.4) or

 Decentralised procedure (DCP) where the medicinal product has not received a MA in a MS at the time of application (Articles 28.1 ; 28.3 and 28.4)

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The Organisation for Professionals in Regulatory Affairs

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