Note that in accordance with the periodic fees for marketing authorisations and licences regulations, all sponsors who hold open clinical trials authorisations (CTAs) on 1 April will receive an invoice for the service fee. This includes all trials which have been approved by the MHRA and for which we have not received an end of trial declaration or trials for which we have not received notification that the trial is no longer active in the UK. This may include approved trials that have not yet started, have been temporarily halted or have ended but we have not yet been notified.
It is not possible to provide exemptions and it is the responsibility of the sponsor to inform the MHRA if a trial has ended and the CTA is closed.
For information regarding how much the Annual Service Fee is for this financial year, please refer to our fees section.
To advise the MHRA that a trial is no longer active at all UK sites, and therefore the trial is no longer subject to the Annual Service Fee, an email should be sent to the CT submission email address (ct.submission@mhra.gsi.gov.uk) containing the following information:
1. The email must be entitled: CTA No Longer Active in UK - CTA Number XXXXX/XXXX/XXX-XXX – EudraCT Number XXXX/XXXXXX/XX
2. The email must be sent by the person listed as the contact person listed in section C.1.4 of the application form (Annex I form).
3. The email should reach the CT Submissions inbox by 17 March of the financial year in which the trial finished at the UK sites in order to allow time for processing prior to the Annual Service Fee calculations which are conducted on 1 April of each year. Emails received after this date may not be processed and therefore the Annual Service Fee may be charged for the following year.
4. The email must contain an organisation headed document which provides the following information
- the EudraCT Number, CTA Number and Protocol Number of the application
- text to confirm that the clinical trial is now complete at each of the UK sites
- the document must be signed.
Once MHRA has received a confirmation that a clinical trial has been completed at all UK sites, the notification will be processed and an acknowledgement will be sent to confirm that the details have been updated.
Following submission of this email, MHRA do not expect to receive any further study amendments since such amendments will not be applicable to the UK sites as they are no longer actively participating in the clinical trial.
To advise the MHRA of the ‘end of trial’ please refer to the End of Trial section on our website.
