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Launching Drug Product in Europe – Regulatory Q&A
Similar to the US, all medicinal products need to obtain a license / Marketing Authorisation (MA) before they can be placed onto the European market. The MA certifies that the product meets the required standards of safety, quality and efficacy. Unlike the US however, there are four main routes of gaining a MA in Europe (Centralised Procedure, Decentralised Procedure, Mutual Recognition Procedure and National Procedure), with varying critical time points throughout the process including clock stop periods, making the process that bit more complicated.
In this Q&A, Almac’s Senior Regulatory Affairs Scientist, David McCoubrey shares his knowledge and experience of the various EU regulatory filing options and explains how your product type will influence your submission route.
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