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Monday, November 27, 2023 6:59:39 PM
Submission dates for 150-days assessment procedure for national marketing authorisation applications containing new active substances.
The MHRA will operate a 150-day Assessment route for high-quality marketing authorisation applications (MAAs).
For applications containing new active substances, submissions should be received by the following dates in order to align with the meeting dates of the Commission on Human Medicines (CHM).
The Marketing authorisation application dossier should be submitted through the MHRA Submissions portal on or before the deadline as detailed below:
CHM meeting ----------------- Submission deadline
25 and 26 January 2024 —-- 30 October 2023
22 and 23 February 2024 — 27 November 2023
21 and 22 March 2024 ——- 25 December 2023
25 and 26 April 2024 ———- 29 January 2024
30 and 31 May 2024 ———- 04 March 2024
https://www.gov.uk/guidance/marketing-authorisation-application-submission-dates-for-150-days-national-and-european-commission-decision-reliance-procedures
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