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 |
|---|---|
| 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 |
| 25 and 26 April 2024 | 29 January 2024 |
| 30 and 31 May 2024 | 04 March 2024 |
| 27 and 28 June 2024 | 01 April 2024 |
| 25 and 26 July 2024 | 29 April 2024 |
| 29 and 30 August 2024 | 03 June 2024 |
| 26 and 27 September 2024 | 01 July 2024 |
| 24 and 25 October 2024 | 29 July 2024 |
| 21 and 22 November 2024 | 26 August 2024 |
| 19 and 20 December 2024 | 23 September 2024 |
| 23 and 24 January 2025 | 28 October 2024 |
| 27 and 28 February 2025 | 02 December 2024 |
| 27 and 28 March 2025 | 30 December 2024 |
| 24 and 25 April 2025 | 27 January 2025 |
| 29 and 30 May 2025 | 03 March 2025 |
| 26 and 27 June 2025 | 31 March 2025 |
| 24 and 25 July 2025 | 28 April 2025 |
| 28 and 29 August 2025 | 02 June 2025 |
| 28 and 29 September 2025 | 03 July 2025 |
| 30 and 31 October 2025 | 04 August 2025 |
| 27 and 28 November 2025 | 01 September 2025 |
| 18 and 19 December 2025 | 22 September 2025 |
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.
Last updated 12 September 2023 + show all updates
-
Updated table of Submission Dates
-
Submission deadlines updated
-
Updated CHM meeting dates.
-
First published.