Detailed GuideMHRA
Rolling review for marketing authorisation applications
Use the rolling review route when you want to submit your eCTD dossier in separate parts for pre-assessment instead of making a full consolidated document submission.
First published: Dec 31, 2020Last updated: Mar 11, 2025Changes: 4
Latest change: Updated to remove: “1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14” from document Rolling review for marketing authorisation applications
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