Dates for your diary

Submission dates for 150-days assessment procedure for national marketing authorisation applications containing new active substances

The MHRA have pledged they will try and operate a 150-day Assessment route for high-quality new marketing authorisation applications (MAAs).

Within this timeframe MHRA have said they will evaluate the application for a UK, Great Britain (England, Wales & Scotland) or Northern Ireland from validation.

For those applications which contain 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).

CHM Meeting

16 & 17 December 2021

27 & 28 January 2022

10 & 11 March 2022

7 & 8 April 2022

5 & 6 May 2022

9 & 10 June 2022

30 June & 1 July 2022

4 & 5 August 2022

1 & 2 September 2022

29 & 30 September

27 & 28 October 2022

24 & 25 November 2022

15 & 16 December 2022

Submission Deadline

20 September 2021

1 November 2021

12 December 2021

9 January 2022

6 February 2022

13 March 2022

3 April 2022

8 May 2022

5 June 2022

3 July 2022

31 July 2022

28 August 2022

18 September 2022

If you need any support or guidance we would be happy to help. Contact us on consultancy@jensongroup.com

James Hall
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