Guidance

Notification Fees for Great Britain and Northern Ireland

Published 24 March 2022

1. Current costs of notifications

Notification fee: £150 (Per ECID notified in both Great Britain and Northern Ireland)

Annual and Substantial Modification fees will be reviewed in 2022-23.

The MHRA has given a commitment to review the level of fees in the light of the number of notifications received each year.

2. Payments via MHRA Submissions

From 1st March 2022 submitters are required to pay for notifications using the integrated Gov.Pay system provided as part of MHRA Submissions. Upon validation of a submission you will be able download your invoice and pay for notifications via MHRA Submissions.

This payment will cover the cost of the notification for Great Britain and Northern Ireland, if the notification has been submitted via MHRA Submissions and EUCEG. Submitters must ensure that product ECIDs are aligned on MHRA Submissions and EUCEG or you will be charged for two product notifications.

If you do not want to submit the notification for assessment or require another company employee to make payments for the submission you will be able to save multiple drafts and complete the submissions and payment at a later time.

Payments for Northern Ireland only notifications must be completed using MHRA Submissions. Upon completing EUCEG and validated MHRA Submissions uploads you will be able to make a payment. If the product is only to be supplied in Northern Ireland, please contact our team to confirm that the payment is to be applied to Northern Ireland only and GB publication is not required. Should you wish to supply to GB in the future no further payment we be required.

Please be aware that our assessment team will not have access to your submissions for review until payment has been completed via MHRA Submissions.

Once the product has been reviewed and published by the MHRA it is legal for supply to the relevant region. Evidence of your product’s published status should be made available to distributors, importers, UK enforcement officers and Border Force representatives upon request.