Law

The Veterinary Medicines (Amendment etc.) Regulations 2024

United Kingdom · regulation

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In force since 2024-05-17, as the publisher states.

Copy read on 2026-11-10. The page it was read from

Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

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Contents: 210 provisions

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210 provisions

160 New paragraph 10

After paragraph 9 insert— Offences 10. It is an offence to fail to comply with— (a) paragraph 3A(1); (b) paragraph 3B; or (c) paragraph 9(1). .

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161 Introduction

Schedule 7 to the 2013 Regulations (fees) is amended in accordance with this Part.

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162 Amendment to paragraph 1

In paragraph 1 (interpretation)— (a) the existing text is renumbered as sub-paragraph (1); (b) in sub-paragraph (1), in the definition of “pharmaceutical product”, at the end insert “or a biological veterinary medicinal product that is not immunological”; (c) after that sub-paragraph insert— (2) For the purposes of this Schedule “manufacturing authorisation” means the following activities— (a) manufacture or import of an authorised veterinary medicinal product; (b) manufacture of a product to which paragraph 2 of Schedule 6 relates; (c) manufacture of a product for administration under the cascade; (d) manufacture of— (i) an autogenous vaccine; (ii) a stem cell product; or (iii) a blood product for administration to non-food animals. .

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163 Amendment to paragraph 4

In paragraph 4 (multiple inspections)— (a) omit “, approval”; (b) after “time,” insert “and in relation to the same legal entity,”.

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164 Amendment to paragraph 7

In paragraph 7 (specified pharmaceutical applications)— (a) after “a pharmaceutical” insert “, immunological or biological that is not immunological”; (b) in sub-paragraph (a)— (i) at the end of paragraph (i) insert “, or”; (ii) in paragraph (ii)— (aa) after “application” insert “for a pharmaceutical veterinary medicinal product”; (bb) omit “or”; (iii) omit paragraph (iii); (c) in sub-paragraph (c) for the table substitute— Application | Fee (£) per authorisation Base fee | 27,995 Fee for 1st additional strength | 4,590 Fee for each subsequent additional strength | 1,465 ; (d) in the heading, after “pharmaceutical” insert “, immunological or biological that is not immunological”.

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165 New paragraph 7A

After paragraph 7 insert— Application for a marketing authorisation for specific applications 7A. The fee for an application for a marketing authorisation which involves one or more of the following is £45,000— (a) any biotechnical process involving recombinant DNA or the controlled expression of genes; (b) a veterinary medicinal product containing a new active substance; (c) a biopharmaceutical product. .

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166 Amendment to paragraph 9

Omit paragraph 9 (application for marketing authorisation for immunological or biosimilar product).

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167 Amendment to paragraph 11

For paragraph 11 (application for marketing authorisation based on informed consent) substitute— Application for a marketing authorisation based on informed consent 11. The fee for applications for marketing authorisations using identical data submitted simultaneously or on the basis of information provided under paragraph 9 of Schedule 1 is as follows— Application | Fee (£) per authorisation Application | 1,465 .

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168 Amendment to paragraph 13

In paragraph 13 (application for exceptional marketing authorisation – immunological)— (a) after “immunological product”, in both places it occurs, insert “or a biological veterinary medicinal product that is not immunological”; (b) in the heading, for “(immunological)” substitute “(immunological or biological non-immunological)”.

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169 Amendment to paragraph 15

Omit paragraph 15 (application for marketing authorisation for parallel import).

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170 New paragraph 15A

After paragraph 15 insert— Fee for a generic marketing authorisation 15A. (1) The fee for a marketing authorisation in respect of a generic veterinary medicinal product is to be calculated in accordance with the following table. Application | Fee (£) per authorisation Hybrid | Standard Base Fee | 13,950 | 12,390 Fee for 1st additional strength | 4,590 Fee for each subsequent additional strength | 1,465. (2) In this paragraph “hybrid” means an application to which paragraph 10A of Schedule 1 applies. .

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171 Amendment to paragraph 17

In paragraph 17 (application for variation to marketing authorisation under national or mutual recognition procedure)— (a) in sub-paragraph (1) omit “18, 19 or”; (b) for the table substitute— Type of variations | Fee (£) Single variations; one change for each product Variation – standard | 2,895 Unless the variation is— (a) a change of route of administration, or the addition of a new one, of— (i) | an immunological product, or a pharmaceutical product for a non-food-producing animal | 5,390 (ii) | a pharmaceutical product for a food-producing animal | 7,135 (b) a change of bioavailability | 8,415 (c) a change of active substance, where the change is to— (i) | use a different biologically active substance with a slightly different molecular structure | 8,415 (ii) | modify the vector used to produce the antigen or the source material, including a new master cell bank from a different source | 8,415 (d) a change of pharmacokinetics | 8,415 Simultaneous application falling within (a) to (d): fee for each additional product in the application | 1,465 Variation – reduced | 885 Variation - no assessment | 455 Grouped variations Variation – standard led For the first nine changes | 6,280 For each subsequent group of five or fewer changes | 2,250 Variation – reduced led: For the first nine changes | 1,770 For each subsequent group of five or fewer changes | 2,250 .

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172 Amendment to paragraph 18

Omit paragraph 18 (application for variation to marketing authorisation under worksharing procedure).

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173 Amendment to paragraph 22

In paragraph 22 (application for renewal of marketing authorisation)— (a) omit sub-paragraph (1); (b) for the heading substitute— Application for a reassessment of an exceptional marketing authorisation .

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174 Amendment to paragraph 25

Omit paragraph 25 (renewal of homeopathic remedy).

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175 Amendment to paragraph 28

In paragraph 28 (application for manufacturing authorisation)— (a) the existing text is renumbered as sub-paragraph (1); (b) for the words from “is—” to the end substitute “is £762”; (c) after sub-paragraph (1) insert— (2) Fees relating to an application for a manufacturing authorisation are payable with the application. .

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176 Amendment to paragraph 29

In paragraph 29 (application for variation to manufacturing authorisation)— (a) in sub-paragraph (a) for “£636” substitute “£684”; (b) for sub-paragraph (b) substitute— (b) £105 if the variation only involves an administrative variation such as a change of ownership.”; (c) omit sub-paragraphs (c) and (d).

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177 Amendment to paragraph 30

In paragraph 30 (application for manufacturing authorisation for autogenous vaccine or product for administration under the cascade)— (a) omit sub-paragraph (1); (b) for sub-paragraph (2) substitute— (2) The fees for the inspection of sites in connection with an authorisation (or an application for authorisation) for the manufacture of unauthorised veterinary medicinal products for administration under the cascade are set out in the following table— Inspection fees Type of site | Fee (£) United Kingdom site | Site outside the United Kingdom Super site | 21,416 | 22,710 Major site | 12,850 | 14,144 Standard site | 6,425 | 7,719 Minor site | 4,283 | 5,577 . (c) omit sub-paragraphs (3) and (4); (d) for the heading substitute— Inspection of sites authorised to manufacture a product for administration under the cascade .

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178 New paragraphs 30A and 30B

After paragraph 30 insert— Autogenous vaccines 30A. (1) The fee for the scientific assessment of an authorisation (or an application for authorisation) to manufacture an autogenous vaccine is £6,962. (2) The fees for the inspection of sites in connection with an authorisation (or an application for authorisation) to manufacture autogenous vaccines are set out in the following table— Inspection fees Type of site | Fee (£) United Kingdom site | Site outside the United Kingdom Super site | 21,416 | 22,710 Major site | 12,850 | 14,144 Standard site | 6,425 | 7,719 Minor site | 4,283 | 5,577 Assessment of a variation of an authorisation to manufacture an autogenous vaccine 30B. The fee for the scientific assessment of an application for the variation of an authorisation to manufacture an autogenous vaccine is— (a) £2,895 if the variation requires complex scientific or pharmaceutical assessment; (b) £885 if the variation requires simple scientific or pharmaceutical assessment; (c) £455 in relation to an administrative variation. .

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179 Amendment to paragraph 31

For paragraph 31 (annual fees) substitute— Annual fee (manufacturing authorisations) 31. An annual fee of £575 is payable in respect of each manufacturing authorisation held. .

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180 Amendment to paragraph 33

In paragraph 33 (inspection of manufacturing site for immunological veterinary medicinal products) for the table substitute— Sites where immunological veterinary medicinal products are manufactured Type of site | Fee (£) United Kingdom site | Site outside the United Kingdom Super site | 32,124 | 33,418 Major site | 21,416 | 22,710 Standard site | 10,708 | 12,002 Minor site | 6,425 | 7,719 .

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181 Amendment to paragraph 34

In paragraph 34 (inspection of manufacturing site for sterile veterinary medicinal products) for the table substitute— Sites where sterile veterinary medicinal products are manufactured Type of site | Fee (£) United Kingdom site | Site outside the United Kingdom Super site | 27,841 | 29,135 Major site | 19,274 | 20,569 Standard site | 10,708 | 12,002 Minor site | 6,425 | 7,719 .

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182 Amendment to paragraph 35

In paragraph 35 (inspection of manufacturing site for other veterinary medicinal products) for the table substitute— Sites where no immunological or sterile veterinary medicinal products are manufactured Type of site | Fee (£) United Kingdom site | Site outside the United Kingdom Super site | 21,416 | 22,710 Major site | 12,850 | 14,144 Standard site | 8,566 | 9,861 Minor site | 4,283 | 5,577 If the site is only involved in the manufacture of veterinary medicinal products authorised under Schedule 6 (exemptions for small pet animals)— Standard site | 3,212 | 4,507 Minor site | 2,142 | 3,436 .

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183 Amendment to paragraph 36

In paragraph 36 (inspection of site where veterinary medicinal products are assembled) for the table substitute— Sites where medicinal products are assembled Type of site | Fee (£) United Kingdom site | Site outside the United Kingdom Super site | 17,133 | 18,427 Major site | 10,708 | 12,002 Standard site | 6,425 | 7,719 Minor site | 4,283 | 5,577 .

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184 Amendment to paragraph 37

In paragraph 37 (test sites)— (a) for “£3,344” substitute “£3,212”; (b) for “£3,177” substitute “£4,507”.

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185 Amendment to paragraph 38

For paragraph 38 (animal blood bank or equine stem cell centre authorisations) substitute— Animal blood bank or non-food animal stem cell centre authorisations 38. (1) The fee for the inspection of a blood bank is— (a) £3,212 for a site in the United Kingdom; and (b) £4,507 for a site outside the United Kingdom. (2) The fee for the inspection of a non-food animal stem cell centre is— (a) £2,142 for a site in the United Kingdom; and (b) £3,436 for a site outside the United Kingdom .

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186 Amendment to paragraph 39

For paragraph 39 (application for wholesale dealer’s authorisation) substitute— Application for a wholesale dealer’s authorisation 39. (1) The fee for an application for a wholesale dealer’s authorisation is £344. (2) Fees relating to an application for a wholesale dealer’s authorisation are payable with the application. .

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187 Amendment to paragraph 40

For paragraph 40 (variation of wholesale dealer’s authorisation) substitute— Variation of a wholesale dealer’s authorisation 40. The fee for an application to vary a wholesale dealer’s authorisation is— (a) £265 if the variation requires scientific or pharmaceutical assessment; (b) £105 for a change of ownership or other administrative variation. .

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188 Amendment to paragraph 41

For paragraph 41 (annual fee for wholesale dealer’s authorisation) substitute— Annual fee for a wholesale dealer’s authorisation 41. The annual fee for a wholesale dealer’s authorisation is £427. .

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189 Amendment to paragraph 42

For paragraph 42 (inspection of wholesale dealer’s premises) substitute— Inspection of a wholesale dealer’s sites 42. The fee for inspection of a wholesale dealer’s site is— (a) £1,177; or (b) £877 if— (i) the authorisation only relates to products classified as AVM-GSL or homeopathic remedies; or (ii) the authorisation only relates to products marketed under Schedule 6 (exemptions for small pet animals). .

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190 Amendment to paragraph 43

In paragraph 43 (approval fees and annual fees for feedingstuffs in Great Britain)— (a) in sub-paragraph (1)— (i) for “approval”, in both places it occurs, substitute “authorisation”; (ii) for “establishments” substitute “premises”; (iii) for “£70” substitute “£105”; (b) in sub-paragraph (2)— (i) for “£70” substitute “£122”; (ii) for “approval” substitute “authorisation”; (c) in sub-paragraph (3)— (i) for “an establishment” substitute “premises”; (ii) for “veterinary medicinal product intended to be incorporated into feedingstuffs” substitute “medicinal premix”; (iii) for “that establishment” substitute “those premises”; (d) in sub-paragraph (4) omit “or on invoice for the subsequent annual fee”; (e) in sub-paragraph (5) for “establishment” substitute “premises by the same legal entity”; (f) in the heading for “approvals” substitute “applications for authorisation”.

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191 Amendment to paragraph 44

In paragraph 44 (inspection fees for feedingstuffs in Great Britain)— (a) in the words before the table for “establishments” substitute “premises”; (b) for the table substitute— Inspection Fees Type of premises inspected | Fee payable (£) Manufacturer of a specified feed additive (SFA) | 1,610 Manufacturer of an intermediate feedingstuff (including balancers) containing a medicinal premix or an SFA | 976 Manufacturer of a feedingstuff for sale containing— a medicinal premix and/or an SFA, and/or an intermediate feedingstuff containing a medicinal premix or an SFA | 841 Manufacturer of a feedingstuff for feeding to their own animals only, containing— a medicinal premix and/or an SFA incorporated at a rate of at least 2kg/t, and/or an intermediate feedingstuff containing a medicinal premix and/or an SFA incorporated at a rate of at least 2kg/t | 476 Distributor or trader of Schedule 5 products (A distributor of specified feed additives, or intermediate feedingstuffs containing specified feed additives or medicinal premixes; or feedingstuffs containing a medicinal premix) | 350 .

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192 Amendment to paragraph 46

In paragraph 46 (premises for supply by suitably qualified persons)— (a) in sub-paragraph (1)— (i) for “to approve” substitute “for an application for the authorisation”; (ii) for “£265” substitute “£105”; (iii) omit paragraph (b) and the preceding “or”; (b) after sub-paragraph (1) insert— (1A) The fees for the inspection of sites authorised for the retail supply of veterinary medicinal products by suitably qualified persons are set out in the following table— Inspection Fees Type of sites inspected | Fee payable (£) Sites authorised to supply companion animal medicines | 285 Sites authorised to supply equine medicines | 285 Sites authorised to supply livestock medicines | 338 Sites authorised to supply avian medicines | 285. (1B) Where a site is inspected in relation to a single authorisation, and falls within more than one of the categories in the table, only one fee (the highest) is payable. ; (c) in sub-paragraph (2)— (i) for “£185” substitute “£57”; (ii) omit paragraph (b) and the preceding “or”; (d) after sub-paragraph (2) insert— (3) The application fee for authorisation of sites for supply is payable with the application. .

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193 Amendment to paragraph 48

In paragraph 48 (animal test certificates)— (a) in sub-paragraph (1) for “£815” substitute “£1,170”; (b) in sub-paragraph (2) for “£30” substitute “£40”; (c) for sub-paragraph (4) substitute— (4) The fee for an application for the variation of the certificate is— (a) in the case of a small scale trial, £40; and (b) in the case of any other trial, £390. ; (d) for sub-paragraph (5) substitute— (5) The fee for an application to renew a certificate is— (a) in the case of a small scale trial, £40; and (b) in the case of any other trial, £190. .

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194 Amendment to paragraph 53

In paragraph 53 (export certificates)— (a) for “£30” substitute “£54”; (b) omit the words from “, and £15” to the end.

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195 New paragraph 54A

After paragraph 54 (provision of advice) insert— Provision of scientific advice 54A. The fee for an application for written advice from the Secretary of State in relation to scientific matters is £4,487. .

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196 Amendment to paragraph 57

In paragraph 57 (veterinary surgeon’s practice premises)— (a) for sub-paragraph (1) substitute— (1) The fees for the inspection of a veterinary practice premises are set out in the following table— Type of premises inspected | Fee payable (£) Sites registered to supply companion animal medicines | 536 Sites registered to supply equine medicines | 536 Sites registered to supply livestock medicines | 536 Mixed practice premises | 698 Any other type of practice | 451 . (b) in sub-paragraph (2), for “£34” substitute “£38”; (c) after sub-paragraph (3) insert— (4) For the purposes of sub-paragraph (1) “mixed practice” means premises supplying veterinary medicinal products to livestock in addition to any other category mentioned in that provision. ; (d) in the heading omit “surgeon’s”.

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197 New paragraphs 57A and 57B

After paragraph 57 insert— Fee in relation to verifying destruction of controlled drug 57A. The fee for verifying the destruction of a controlled drug listed in Schedule 2, 3 or 4 to the Misuse of Drugs Regulations 2001 is— (a) £142; or (b) £31 (where the verification takes place during the course of an inspection for other purposes). Pharmacovigilance inspections 57B. (1) In relation to a pharmacovigilance inspection the fee is— (a) £3,600 in the case of a large marketing authorisation holder; and (b) £1,650 in the case of a small marketing authorisation holder. (2) In sub-paragraph (1)— “large marketing authorisation holder” means a marketing authorisation holder who holds 30 or more marketing authorisations; “small marketing authorisation holder” means a marketing authorisation holder who holds fewer than 30 marketing authorisations. .

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198 Amendment to paragraph 60

In paragraph 60 (non-payment of fees)— (a) omit “(other than any fee relating to a manufacturing authorisation or wholesale dealer’s authorisation)”; (b) after “from the person” insert “or any authorisation held by the person”.

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199 Amendment to paragraph 61

After paragraph 61(1) (waiver or reduction of fees) insert— (1A) If the Secretary of State is satisfied that exceptional circumstances exist the Secretary of State may waive or reduce an inspection fee payable under these Regulations. .

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