Guidance

General

Published 16 May 2024

Applies to Northern Ireland

1. Renewal of an Exceptional marketing authorisation

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
PRP2	Exceptional Marketing Authorisation: First reassessment	305	22(2)
PRP3	Exceptional Marketing Authorisation: Subsequent reassessment	1,360	22(2)

2. Annual fees for marketing authorisations

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
YGAF1	Graded Annual Fee: % on turnover in the UK	0.67%	26(2)
YFAF1	Fixed Annual Fee for each GB MA, NI MA and UK wide MA: turnover in the UK of authorised products equal to or greater than £230,000	£ (0.67T / 100) + £230n Where “T” is the annual turnover and “n” is the number of active marketing authorisations	26(2)
YFAF2	Fixed Annual Fee for each GB MA, NI MA and UK wide MA: turnover of authorised products less than £230,000	£ (0.67T / 100) + £200n Where “T” is the annual turnover and “n” is the number of active marketing authorisations	26(3)
	Failure to provide an audit certificate: Base fee	11,300	27(2)
	Failure to provide an audit certificate: Fee for each MA held	2,245	27(2)

3. Specific batch control

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
BC10	Authorisation to release a product under specific batch control	560	51 (a)
BC15	Additional batches at application where all subsequent batches affected by same issue; per additional batch	100	51(b)
BC81A	Submission of results of tests carried out on a batch of immunological products prior to release on to the UK markets	80	52

4. Test sites, Blood Banks, Stem Cells

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
SS47	Test site inspection	3,344	37
BBA1	Blood bank: authorisation to operate; first inspection	3,113	38(1)a
BBA5	Blood bank: subsequent inspection	3,113	38(1)b(i)
N/A	Variation of a blood bank authorisation	320	38(3)
BSC1	Stem Cell product: authorisation	3,427	38(2)
BSC2	Stem Cell product: subsequent inspection	3,092	38(2)
BSV1	Stem Cell product: variation	320	38(3)

5. Inspection improvement notices

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
N/A	The full economic cost of any inspection necessary as a result of the issue of an improvement notice is payable by the person on whom the notice was served	-	59

6. Approval of premises for supply by Suitably Qualified Persons

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
1601	Approval of premises	265	46(1)(a)
SQPAM	Subsequent annual fee	185	46(2)(a)
1607	Approval of premises; horses only	145	46(1)(b)(i)
SQPAJ	Subsequent annual fee; horses only	95	46(2)(b)(i)
1604	Approval of premises; horses and companion animals only	145	46(1)(b)(i)
SQPAS	Subsequent annual fee; horses and companion animals only	95	46(2)(b)(i)
1610	Approval of premises; companion animals only	110	46(1)(b)(ii)
SQPAC	Subsequent annual fee: companion animals only	70	46(2)(b)(ii)

7. Veterinary surgeon’s practice inspection

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
PI01	Inspection	350	57(1)

8. Special Import and Export certificates

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
SIC1	Special Import Certificate (SIC): postal application; product authorised in another country	15	49(1)a
N/A	Special Import Certificate (SIC): online application	no fee	49(3)
WDIC1	Wholesale Dealers Import Certificate*	1,320	50(1)
XPC1	Export Certificate; each	30	53
XPC2	Export Certificate certified copy of each original	15	53

*only payable if, in the twelve-month period immediately before the application, the applicant has supplied the veterinary medicinal product to which the certificate relates in accordance with at least 100 certificates.

9. Appeal to the Veterinary Products Committee

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
VA30	The fee for an appeal to the Veterinary Products Committee	1,500	55

10. Referral to an appointed person

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
N/A	The appellant is liable for the full economic cost of a referral, subject to a maximum of £5,000. These fees are refunded if the decision is reversed	-	56

11. Non-payment of fees

Fee code	Description	Fee from 01/10/13	VMR 2013 SCH 7 Para
N/A	Where any fee, other than any fee relating to a manufacturing authorisation or wholesale dealer’s authorisation, is not paid, the Secretary of State may, after giving 1 month’s written warning, suspend the processing of any application from the person who has not paid the fee		60