For 2 years from the 1 January 2021, the MHRA may rely on a decision taken by the European Commission on the approval of a new MA in the centralized procedure when determining an application for a GB Marketing Authorisation via EC Decision Reliance Procedure (ECDRP). GB MA could be determined within 2,5 months from the day EC decision has been received.
Full Summary of Regulatory Process you could find here:
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All existing CAP MAs have been automatically converted into UK MAs effective in Great Britain (only) and issued with a UK MA number on 1 January 2021. These UK MAs are referred to in this guidance as “converted EU MAs”. As a result of the implementation of the Northern Ireland Protocol, existing CAPs will remain valid for marketing products in Northern Ireland. From the regulatory perspective, Northern Ireland will remain covered by the EMA centralized procedure (CAP) and could be part of DCP/MRP procedure as CMS.
Although the MHRA will remain responsible for the monitoring and enforcement in this territory.
For the new application you still could add NI(full form here) as a CMC but wouldn't have access to the GB market with the same MA as it was previously.
In order to reduce the impact and speed up access to the critical MHRA implemented a couple of piggyback strategies for the transition period.
Until January 1st, 2023, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the European Commission (EC) on the approval of a new MA in the centralized procedure.
For the products that have been submitted via centralized procedure for review by the EMA there are 2 potential routes in adding the new UK marketing authorization:
- Standalone GB application: Parallel national Market Authorization Application Assessment in which the manufacturer/future MAH applies to the MHRA in parallel with EMA CAP
- Reliance Route in which the manufacturer can wait until the CHMP has issued a positive opinion before applying to the MHRA for a UK marketing authorization
GB national application requirements and procedure will remain the same, but we should discuss how your market access to the UK could be made faster with Reliance Route.
The intended operation of the ECDRP is submission of the Marketing Authorisation Application (MAA) to the MHRA immediately on receipt of a positive Committee for Medicinal Products for Human Use (CHMP) opinion, although applications can be submitted any time after the approval of a European Union Marketing Authorisation.
- When a submission is made within 5 days of CHMP positive opinion, the date of CHMP positive opinion will be designated Day 0 of the ECDRP
- 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 be delayed
- Great Britain MA will be determined by Day 67 at the latest (upon the EC decision being received)
- Any issues identified during assessment will be communicated to the applicant by Day 46 and should be resolvable within the 67-day timetable without clock-stop
- If Major Objections are identified or substantial amendments to the product information are necessary, the timetable will move to the standard National Procedure timetable. It is anticipated that this will be necessary only on rare occasions.
- The submission will attract a fee payable to the MHRA
- Apply for a PLGB number on MHRA Submissions Portal or by emailing
- Letter of intent to the ECDRP mailbox (4 weeks before ECDRP MAA)
- On receipt of the positive CHMP opinion, submit ECDRP MAA eCTD package as soon as possible (5 days after opinion) via Submission Portal
Submission should include:
- Cover letter
- Dossier as reviewed by the CHMP (in eCTD format)
- Full responses to CHMP questions
- All iterations of the CHMP assessment reports and the CHMP opinion for the initial MAA and any subsequent variations (Working documents folder)
- Proposed product information in Word format
While the UK recognizes European Commission decisions through the Reliance Route, there should be a limited impact on access and some additional regulatory burden on pharmaceutical manufacturers.
Full MHRA guidance on how to apply for marketing authorisation via this new European Commission (EC) Decision Reliance procedure can be found on their website: https://www.gov.uk/guidance/european-commission-ec-decision-reliance-procedure
If you would like support with your regulatory activities following these changes, visit our website https://brexit.freyrsolutions.com/ or get in touch email@example.com for more.