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:

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.