Transcription of PSUR Repository user guide for MAH submissions
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PSUR Repository user guide for MAH submissions
Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged. 09 June 2020 EMA/52449/2015 User Guidance for Marketing Authorisation Holders (MAHs) for PSUR Repository Table of contents 1. Introduction .. 5 Scope of the PSUR Repository .. 5 2. The submission Process .. 5 Introduction of attribute submission unit in eCTD EU Module 1.
The use of the PSUR Repository is mandatory since 13th June 2016 and the submission of PSURs directly to National Competent Authorities is no longer accepted. It is now mandatory to submit PSURs in eCTD format. For more information, please see the eSubmission website. At a high level, submission to the PSUR repository is a two-step process: 1.
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