Guidance

General

Updated 4 July 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