Guidance

Marketing Authorisation Application submission dates for 150-days national and European Commission decision reliance procedures

Submission dates and how the submissions using the EC decision reliance procedure work.

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
2 and 3 September 2021 07 June 2021
30 September and 1 October 2021 05 July 2021
28 and 29 October 2021 02 August 2021
25 and 26 November 2021 30 August 2021
16 and 17 December 2021 20 September 2021
27 and 28 January 2022 01 November 2021
10 and 11 March 2022 12 December 2021
7 and 8 April 2022 09 January 2022
5 and 6 May 2022 06 February 2022
9 and 10 June 2022 13 March 2022
30 June and 01 July 2022 03 April 2022
4 and 5 August 2022 08 May 2022
1 and 2 September 2022 05 June 2022
29 and 30 September 2022 03 July 2022
27 and 28 October 2022 31 July 2022
24 and 25 November 2022 28 August 2022
15 and 16 December 2022 18 September 2022
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 25 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
25 and 26 April 2024 29 January 2024
30 and 31 May 2024 04 March 2024

Submissions using the EC decision reliance procedure (ECDRP)

Applicants may seek a Great Britain marketing authorisation that relies on a decision taken by the European Commission in respect of a marketing authorisation for the same product in the centralised procedure (for a period of two years from 1 January 2021). This route – the EC decision reliance procedure (ECDRP) - is available to all authorisations including generics products and variations, approved in the centralised procedure.

For new MA applications, on receipt of the positive CHMP (Committee for Medicinal Products for Human Use) opinion on day 210, or as soon as possible after this date, the ECDRP MAA should be submitted to the MHRA as a single electronic Common Technical Document sequence through MHRA Submissions. The submission should include the entire dossier as reviewed by the CHMP, including the full responses to CHMP questions, each iteration of the rapporteur assessment report and updates throughout the procedure

When a valid submission is made within 5 days of CHMP positive opinion, the date of CHMP positive opinion will be designated Day 0 of the ECDRP, and the MHRA will aim to determine the Great Britain MA as soon as possible following submission of confirmation of the EC decision.

If the application is submitted more than 5 days after the CHMP positive opinion, Day 0 of the ECDRP will be the date of MAA validation, and determination may not align with the date of the EC decision.

Published 1 February 2021
Last updated 20 June 2022 + show all updates
  1. Submission deadlines updated

  2. Updated CHM meeting dates.

  3. First published.