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marketing authorisation dossier. Whilst the latter ones have to ensure a state-of-the-art quality of a product for wide use in patients, information to be provided for investigational medicinal products (IMPs) should focus on the risk aspects and should consider the nature of …
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www.ema.europa.euThe investigational medicinal product dossier ( IMPD) should be provided in a clearly structured format following the CTD format of Module 3 and include the most up-to-date available information relevant to the clinical trial at time of submission of the clinical trial application.