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European Medicines Agency - The United Kingdom (UK) withdrew from the European Union (EU) on 31 January 2020 and is no longer an EU Member State.
Dossier requirements for Referrals, ASMFs and Nationally authorised products * for CAT, the dossier is only required by its members if the product is an advanced therapy (AT). ** From 1 January 2021 this will no longer include UK authorities.
Dossier requirements for submission of MA and MRL applications Keywords Dossier requirements for submission of marketing authorisation and maximum residue limit (MRL) applications to the European Medicines Agency (EMA) and to members of the Committee for Medicinal Products for Veterinary use (CVMP) The IMP dossier (IMPD) • Quality data • Non clinical data (module 4 CTD) • Clinical data (module 5 CTD) • B/R analysis - Content adapted to the level of knowledge (phase of development) - Summaries of studies and not the study reports • A simplified dossier is possible • Cross reference is possible (previous CTA) •
Current eCTD EU Module 1 Specification EU Module 1 v3.0 .3; The EU Harmonised technical eCTD guidance version 4.0 ; eCTD validation criteria v7.1 and Release notes - 02.03.2018. Entered into force on 1st of September 2018. Variations in eCTD format Q&A document covering practical issues for variations in eCTD format Volume 2 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information and classification for the supply, readability of the label
Histoire / Geschichte 2. Das nachfolgende Dossier, entstanden in Kooperation mit dem Deutschen Historischen Institut Paris (DHIP), befasst sich mit dem ...