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Sunday, February 25, 2024 12:53:25 AM
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
27 and 28 January 2023 01 November 2022
23 and 24 February 2023 28 November 2022
23 and 24 March 2023 26 December 2022
27 and 28 April 2023 30 January 2023
25 and 26 May 2023 27 February 2023
29 and 30 June 2023 03 April 2023
27 and 28 July 2023 01 May 2023
24 and 26 August 2023 29 May 2023
28 and 29 September 2023 03 July 2023
26 and 27 October 2023 31 July 2023
23 and 24 November 2023 28 August 2023
21 and 22 December 2023 25 September 2023
25 and 26 January 2024 30 October 2023
22 and 23 February 2024 27 November 2023
21 and 22 March 2024 25 December 2023
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