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

Medicines Healthcare Products Regulatory Agency

September 12
09:15 2023

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.

Published 1 February 2021
Last updated 12 September 2023 +show all updates
  1. Updated table of Submission Dates

  2. Submission deadlines updated

  3. Updated CHM meeting dates.

  4. First published.

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