In this section...
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).
Guidance on how the applicable fees and how to pay is given below:
|
Type of Amendment
|
Supporting Data
|
Fee Payable
|
|---|---|---|
| Protocol changes for which MHRA approval is required | Application form Supporting data |
None |
| Changes to the IMP dossier | Application form Supporting data |
£265 for one section of the dossier to be changed. |
| £530 for two sections of the dossier to be changed | ||
| £795 for three sections of the dossier to be changed |
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. Please quote the EudraCT number, product name, protocol code and clinical trial authorisation (CTA) number (where available) when making payments for clinical trials.
Payment by cheque
Cheques should be made payable to the Medicines and Healthcare products Regulatory Agency. Cheques should be accompanied by a covering letter, and the EudraCT number product name, protocol code and CTA number (where available) should be stated on the back of the cheque. The payment and covering letter should be sent to our finance department.
| Please note; the Variation Deposit Scheme will no longer be available for payment of Clinical Trial Application fees. Any applications received after 31 January 2011 which use the Variation Deposit Scheme for payment of CTA fees will be rejected. For guidance on the acceptable forms of payment for CTAs please refer to the Fees pages on our website. |
Contact for further information
For further information on paying fees, contact the Cashiers Department on 020 3080 6507 or by email to cashiers@mhra.gsi.gov.uk
