Clinical trials - Microscope closeup

Costs

The requirement to provide payment of capital fees at the time of submission is a legal requirement specified in the MHRA Fees Regulations. Payment at a different time (eg on invoice) is not acceptable. Proof of payment must be clearly stated in the covering letter and/or as a separate document (eg photocopy of cheque / confirmation of bank transfer). A purchase order, or a letter of instruction to the bank to make a payment, is not considered an acceptable proof of payment.

There is no fee for applications submitted and authorised under the Notification Scheme. However, if an objection to the notification is raised and the application is not authorised under the Notification Scheme, a fee will be charged for assessment of the application and an invoice requiring payment of the fee will be sent to the applicant.

Guidance on the applicable fees and how to pay is given below:
 

Type of APPLICATION Fee payable from 1 April 2013
Applications with an IMP Dossier* £3,400
Applications without an IMP Dossier* £250
Clinical Trial Variation/Amendment £250
Phase IV Notification £0

* For the purposes of fee determination, an application supported by Quality data for blinding purposes (for example placebo comparator or over-encapsulation) remains within the category of Applications without an IMP Dossier.

Payment options

The method of fee payment should be stated in the covering letter to the submission. Please be aware that failure to provide sufficient information on your electronic remittance to our bankers and/or not quoting the required bank details stipulated below may result in your payment being returned to you.

It is essential that when making payments for clinical trials you quote the EudraCT number. Please also make reference to the product name, protocol code and clinical trial authorisation (CTA) number (where available).

Making a payment to the MHRA

Payment by bank transfer
Please refer to the 'Our bank account details' section of the website.

Contact for further information

For information about clinical trial fees, contact the Clinical Trial Helpline on 020 3080 6456 or by email to clintrialhelpline@mhra.gsi.gov.uk

For further information on how to pay fees, contact the Cashiers Department on 020 3080 6507 or by email to cashiers@mhra.gsi.gov.uk


Page last modified: 05 June 2013