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||7 June 2021|
|30 September and 1 October 2021||5 July 2021|
|28 and 29 October 2021||2 August 2021|
|25 and 26 November 2021||30 August 2021|
|16 and 17 December 2021||20 September 2021|
|27 and 28 January 2022||1 November 2021|
|10 and 11 March 2022||12 December 2021|
|7 and 8 April 2022||9 January 2022|
|5 and 6 May 2022||6 February 2022|
|9 and 10 June 2022||13 March 2022|
|30 June and 01 July 2022||3 April 2022|
|4 and 5 August 2022||8 May 2022|
|1 and 2 September 2022||5 June 2022|
|29 and 30 September 2022||3 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|
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. 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.