Fees for clinical trials

From 1 November 2007, letters from the MHRA relating to clinical trial submissions will not be signed. The wording and format of letters from the MHRA relating to clinical trial submissions will also be modified from this date. This is in line with MHRA policy.

1. For authorisation of a clinical trial

Type of trial	Supporting data	Fee payable from 1 April 2007
Phase I Healthy Volunteer trial	Covering letter, Application form*, IMP dossier, Protocol, Investigator’s brochure	£2,146
Phase I, Phase II or Phase III patient trial with an unknown product	Covering letter, Application form*, IMP dossier containing relevant supporting information, Protocol, Investigator’s brochure	£4,040
Phase I, Phase II or Phase III patient trial with an known product	Covering letter, Application form*, IMP dossier containing relevant supporting information, Protocol, Investigator’s brochure	£3,283
Phase IV trial	Covering letter, Application form*, SmPC (in English), Protocol	£252
Additional protocol [same sponsor and same product (s)]	Covering letter, Application form*, Protocol	£252
Cross-referral	Covering letter, Application form*, Protocol, Letter of cross-reference	£252

* a PDF and an xml file

2. For substantial amendments to a clinical trial

Type of Amendment	Supporting Data	Fee Payable
Additional investigational site (notification only change)	Application form	None
Other changes for which no MHRA approval is required - notification only changes	Application form	None
Protocol changes for which MHRA approval is required	Application form Supporting data	None
Changes to the IMP dossier	Application form Supporting data	£252 for one section of the dossier to be changed.
		£505 for two sections of the dossier to be changed
		£757 for three sections of the dossier to be changed

3. Annual service fee
The annual service fee will be routinely due on 31 March. Invoices will be sent out from the Finance Department. For 2008, the fee is £326 payable in full at the time of invoicing.

4. How do I pay the fees?
The method of fee payment should be stated in the covering letter to the submission.

Remittance advices, marked for the attention of the Cashier, should be sent to the address below or faxed to 020 7084 2528. Alternatively, e-mail cashiers@mhra.gsi.gov.uk

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 EudraCT number, product name, protocol code and CTA number (where available) when making payments for clinical trials.

5. 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:

Finance Department
MHRA
Market Towers
1 Nine Elms Lane
London
SW8 5NQ

6. Payment by bank transfer
Bank Details for Payment by Bank Transfer
Please send remittances for the attention of the Cashier by fax to 020 7084 2528 or e-mail to cashiers@mhra.gsi.gov.uk.

BACS Payments
Bank Name: Bank of England.
Sort Code: 10-14-99.
Account Number: 06781000.
Bank Address: Government Counter, Threadneedle Street, London, EC2R 8AH.

Sterling CHAPS Payment from a UK Account
Bank Name: Natwest Bank
Sort Code: 16-53-60
Account Number: 6781
Reference: MHRA
Bank Address: 6 Coldharbour Lane, Hayes, Middlesex, UB3 3EL

For EURO currency payments from a Member State
Account Name: Office of HM Paymaster General - Euro Receipts.
Sort Code: 60-10-43.
Account Number: 5500108304793.
Swift Code: NWBKGB2L.
Reference: 6781 MHRA (please ensure this is quoted on transfer).
IBAN: GB43NWBK60720608304793, OPG Euro Receipts Account.
Branch Address: Natwest Bank.
Bank Address: 6 Coldharbour Lane, Hayes, Middlesex, UB3 3EL.

For all other Overseas transfers
Account Name: Office of HM Paymaster General - Cash a/c
Sort Code: 10-00-00
Account Number: 25021001
Swift Code: BKENGB33
Reference: 6781 MHRA (please ensure this is quoted on transfer)
IBAN: GB57BKEN10000025021001
Bank Name: Bank of England
Bank Address: Government Counter, Threadneedle Street, London, EC2R 8AH

7. Contact for further information
For further information on paying fees, contact Cashiers Department on 020 7084 2524 or 2507 or by e-mail to cashiers@mhra.gsi.gov.uk.