The Veterinary Medicines Regulations 2013

PART 2 U.K. Authorised veterinary medicinal products

Placing a veterinary medicinal product on the market E+W+S

4.— [F1 (1) No person may place a veterinary medicinal product on the market unless the Secretary of State has—

(a) as regards a product to which Schedule 1B applies, issued a QNIG certificate in respect of that product;

(b) otherwise, granted a marketing authorisation in respect of that product.]

(2) No person may certify data in relation to an application for a marketing authorisation or in relation to an existing marketing authorisation if they know that those data are false, or do not believe that they are accurate.

(3) Schedule 1 (marketing authorisations) has effect.

[F2 (4) Schedule 1A (converted EU marketing authorisations) has effect.]

[F3 (5) Schedule 1B (Northern Ireland qualifying good marketing authorisations) has effect. ]

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Reg. 4(1) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1, 3(3) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)(3)(a)); 2020 c. 1, Sch. 5 para. 1(1)

F2 Reg. 4(4) inserted (E.W.S.) (31.12.2020) by The Food and Drink, Veterinary Medicines and Residues (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/865), regs. 1(2), 17(2); 2020 c. 1, Sch. 5 para. 1(1)

F3 Reg. 4(5) inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(2)

Placing a veterinary medicinal product on the market N.I.

4.—(1) No person may place a veterinary medicinal product on the market unless that product has been granted a marketing authorisation by the Secretary of State or the Agency.

(2) No person may certify data in relation to an application for a marketing authorisation or in relation to an existing marketing authorisation if they know that those data are false, or do not believe that they are accurate.

(3) Schedule 1 (marketing authorisations) has effect.

Extent Information

E6 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Manufacture of veterinary medicinal products U.K.

5.—(1) The holder of a marketing authorisation must ensure that every stage in the manufacture of the veterinary medicinal product is carried out by the manufacturer specified in the marketing authorisation(1).

(2) Schedule 2 (the manufacture of veterinary medicinal products) has effect.

[F4 (3) “Manufacture” includes any part of the manufacture of a veterinary medicinal product until the finished product is ready for sale in its final form as specified in the marketing authorisation but does not include the manufacture of an ingredient or breaking open the package of a veterinary medicinal product(2).]

Textual Amendments

F4 Reg. 5(3) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 5

Marketing of products not in accordance with a marketing authorisation U.K.

6.  The holder of a marketing authorisation for a veterinary medicinal product is guilty of an offence if either the holder or the manufacturer supplies a product that is not completely in accordance with the marketing authorisation.

Classification, supply and possession of the product U.K.

7.—(1) Schedule 3 (classification and supply, wholesale dealers and sheep dip) has effect.

(2) No person may supply a veterinary medicinal product [F5 (including a veterinary medicinal product which has been incorporated into a medicated feedingstuff or intermediate feedingstuff)] that has passed its expiry date.

(3) No person may open the package (including the outer package) of a veterinary medicinal product before it has been supplied to the final user, other than as permitted under Schedule 3.

(4) No person may supply an authorised human medicinal product for administration to an animal (other than a product supplied by a veterinary surgeon or in accordance with a written prescription from a veterinary surgeon that includes all the information specified in paragraph 6 of Schedule 3).

(5) No person may be in possession of a veterinary medicinal product that was supplied to that person other than in accordance with Schedule 3.

Textual Amendments

F5 Words in reg. 7(2) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 6

Administration of the product E+W+S

8.  No person may administer a veterinary medicinal product to an animal unless—

(a) the product has a marketing authorisation authorising its administration in the United Kingdom, and the administration is in accordance with that marketing authorisation; or

(b) it is administered in accordance with Schedule 4 (administration of a veterinary medicinal product outside the terms of a marketing authorisation) or Schedule 6 (exemptions for small pet animals).

Extent Information

E2 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Administration of the product N.I.

8.  No person may administer a veterinary medicinal product to an animal unless—

(a) the product has a marketing authorisation authorising its administration in [F17 Northern Ireland], and the administration is in accordance with that marketing authorisation; or

(b) it is administered in accordance with Schedule 4 (administration of a veterinary medicinal product outside the terms of a marketing authorisation) or Schedule 6 (exemptions for small pet animals).

Extent Information

E7 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F17 Words in reg. 8(a) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(3)

Importation of authorised veterinary medicinal products E+W+S

9.— [F6 (1) No person may import, or move into Great Britain from Northern Ireland, a veterinary medicinal product authorised for use in Great Britain except in accordance with this regulation.]

(2) A holder of a marketing authorisation for a veterinary medicinal product may import that veterinary medicinal product.

(3) A holder of a manufacturing authorisation may import a veterinary medicinal product to which that authorisation relates.

(4) An authorised wholesale dealer may import a veterinary medicinal product if—

(a) the authorisation covers the product; and

(b) the dealer has notified the holder of the marketing authorisation in writing before importation.

(5) A veterinary surgeon or a pharmacist may import any authorised veterinary medicinal product.

(6) A suitably qualified person (registered in accordance with paragraph 14 of Schedule 3) may import any authorised veterinary medicinal product that that person is permitted to supply.

(7) There are no restrictions on the importation of an authorised veterinary medicinal product in category AVM-GSL.

Extent Information

E3 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F6 Reg. 9(1) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(3)

Importation of authorised veterinary medicinal products N.I.

9.—(1) No person may import a veterinary medicinal product authorised for use in [F18 Northern Ireland] except in accordance with this regulation.

(2) A holder of a marketing authorisation for a veterinary medicinal product may import that veterinary medicinal product.

(3) A holder of a manufacturing authorisation may import a veterinary medicinal product to which that authorisation relates.

(4) An authorised wholesale dealer may import a veterinary medicinal product if—

(a) the authorisation covers the product; and

(b) the dealer has notified the holder of the marketing authorisation in writing before importation.

(5) A veterinary surgeon or a pharmacist may import any authorised veterinary medicinal product.

(6) A suitably qualified person (registered in accordance with paragraph 14 of Schedule 3) may import any authorised veterinary medicinal product that that person is permitted to supply.

(7) There are no restrictions on the importation of an authorised veterinary medicinal product in category AVM-GSL.

Extent Information

E8 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F18 Words in reg. 9(1) substituted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(4)

Advertising the product E+W+S

10.— [F7 (1) No person may issue an advertisement relating to a relevant substance unless that advertisement—

(a) is set out in such a way that it is clear that the message is an advertisement for the purpose of promoting the supply, sale, prescription, distribution or use of the substance;

(b) encourages responsible use of the substance while presenting its characteristics in an objective manner;

(c) contains no information which—

(i) is misleading;

(ii) is incompatible with the summary of product characteristics in relation to the substance;

(iii) might encourage improper use of the substance; or

(iv) where the relevant substance is a veterinary medicinal product, might suggest that the substance is a feedingstuff or a biocide.

(1A) No person may advertise a veterinary medicinal product, other than a product which is placed on the market in accordance with Schedule 6, unless—

(a) a marketing authorisation has been granted in respect of that product, and

(b) that authorisation is not currently suspended in accordance with paragraph 38 of Schedule 1.]

(2) No person may advertise an authorised human medicinal product for administration to animals (including sending a price list of, or including, authorised human medicinal products to a veterinary surgeon or veterinary practice).

(3) Paragraph (2) does not apply to the holder of a wholesale dealer’s authorisation who supplies a list of authorised human medicinal products, together with prices, to a veterinary surgeon for use under the cascade provided that—

(a) the list is sent following a request from the veterinary surgeon to whom it is sent; and

(b) the list states clearly that the product does not have a marketing authorisation as a veterinary medicinal product, and may only be prescribed and administered under the cascade.

[F8 (4) In this regulation, subject to paragraph (5), “relevant substance” means—

(a) a veterinary medicinal product;

(b) a medicinal premix;

(c) an intermediate feedingstuff; or

(d) a compound feed.

(5) In this regulation, coccidiostats and histomonostats are not relevant substances.]

Extent Information

E4 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F7 Reg. 10(1)(1A) substituted for reg. 10(1) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 7(a) (with reg. 201)

F8 Reg. 10(4)(5) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 7(b) (with reg. 201)

Advertising the product N.I.

10.—(1) No person may advertise a veterinary medicinal product if the advertisement is misleading or contains any medicinal claim that is not in the summary of product characteristics.

(2) No person may advertise an authorised human medicinal product for administration to animals (including sending a price list of, or including, authorised human medicinal products to a veterinary surgeon or veterinary practice).

(3) Paragraph (2) does not apply to the holder of a wholesale dealer’s authorisation who supplies a list of authorised human medicinal products, together with prices, to a veterinary surgeon for use under the cascade provided that—

(a) the list is sent following a request from the veterinary surgeon to whom it is sent; and

(b) the list states clearly that the product does not have a marketing authorisation as a veterinary medicinal product, and may only be prescribed and administered under the cascade.

Extent Information

E9 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

[F9 Inducements and hospitality E+W+S

10A.— (1) Subject to paragraphs (2) and (4), where veterinary medicinal products are being promoted to persons qualified to prescribe or supply veterinary medicinal products, no person may supply, offer or promise to any person any gift, pecuniary advantage or benefit in kind unless it is inexpensive and relevant to the practice of veterinary medicine or pharmacy.

(2) The provisions of paragraph (1) do not prevent any person offering hospitality (including the payment of travelling or accommodation expenses) at events for purely professional or scientific purposes to persons qualified to prescribe or supply veterinary medicinal products, provided that—

(a) it is subordinate to the main scientific objective of the event; and

(b) it is offered only to animal health professionals.

(3) Subject to paragraph (4), no person may offer hospitality (including the payment of travelling or accommodation expenses) at a meeting or event held for the promotion of veterinary medicinal products unless—

(a) it is subordinate to the main purpose of the meeting or event, and

(b) the person to whom it is offered is an animal health professional.

(4) Nothing in this regulation affects measures or trade practices relating to prices, margins or discounts which were in existence on the date on which the Veterinary Medicines (Amendment, etc.) Regulations 2024 came into force.

(5) No person qualified to prescribe or supply veterinary medicinal products may solicit or accept any gift, pecuniary advantage, benefit in kind, hospitality or sponsorship prohibited by this regulation.]

Textual Amendments

F9 Reg. 10A inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 8

Advertising of prescription products and products containing psychotropic drugs or narcotics U.K.

11.—(1) No person may advertise a veterinary medicinal product that—

(a) is available on veterinary prescription only; or

(b) contains psychotropic drugs or narcotics.

(2) In the case of a product containing psychotropic drugs or narcotics, paragraph (1) does not apply to advertisements aimed at veterinary surgeons or pharmacists.

(3) Subject to paragraph (4) in the case of POM-V medicines, paragraph (1) does not apply to price lists, or to advertisements aimed at—

(a) veterinary surgeons;

(b) veterinary nurses;

(c) pharmacists; or

(d) professional keepers of animals.

(4) No person may advertise [F10 antimicrobials] to professional keepers of animals.

(5) In the case of POM-VPS medicines, paragraph (1) does not apply to price lists, or to advertisements aimed at—

(a) veterinary surgeons;

(b) pharmacists;

(c) suitably qualified persons registered in accordance with paragraph 14 of Schedule 3;

(d) other veterinary health care professionals; or

(e) professional keepers of animals.

[F11 (6) A person advertising a veterinary medicinal product must—

(a) include in that advertisement the statement “prescription decisions are for the person issuing the prescription alone”;

(b) ensure that all factual statements concerning the characteristics of the product in the advertisement are consistent with the summary of product characteristics submitted in respect of the product under Schedule 1, as amended.]

Textual Amendments

F10 Word in reg. 11(4) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 9(a) (with reg. 201)

F11 Reg. 11(6) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 9(b) (with reg. 201)

Defence of publication in the course of business U.K.

12.  In proceedings for an offence under these Regulation 43(g), it is a defence for the person charged to prove—

(a) that that person’s business is to publish or arrange for the publication of advertisements, and

(b) that the advertisement was received in the ordinary course of business and the person charged did not know and had no reason to suspect that its publication would amount to an offence under these Regulations.

Wholesale dealing U.K.

13.  No person may buy a veterinary medicinal product, other than by retail or for the purposes of retail supply in accordance with Schedule 3, unless the buyer has a wholesale dealer’s authorisation granted by the Secretary of State under this regulation and Schedule 3.

Feedingstuffs U.K.

14.  Schedule 5 (medicated feedingstuffs and specified feed additives) has effect.

Exemptions E+W+S

15.—(1) These Regulations do not apply to an inactivated autogenous vaccine that is manufactured, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal and used for the treatment of that animal.

(2) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to an inactivated autogenous vaccine that is—

(a) manufactured by a person and in premises authorised in accordance with Part 2 of Schedule 2, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal; and

(b) used for the treatment of—

(i) other animals on the same site;

(ii) animals intended to be sent to those premises; or

(iii) animals on a site that receives animals from those premises.

(3) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to—

(a) blood or blood constituents from a blood bank authorised in accordance with [F12 Part 2] of Schedule 2;

(b) a product manufactured for administration under the cascade by a person and in premises authorised in accordance with [F13 Part 2] of Schedule 2; or

(c) F14 ... stem cell products for use as an autologous treatment for [F15 non-food producing animals] from an F14 ... collection centre authorised in accordance with [F16 Part 2] of Schedule 2.

(4) Schedule 6 (exemptions for small pet animals) has effect.

Extent Information

E5 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F12 Words in reg. 15(3)(a) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 10(a)

F13 Words in reg. 15(3)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 10(b)

F14 Word in reg. 15(3)(c) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 10(c)(i)

F15 Words in reg. 15(3)(c) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 10(c)(ii)

F16 Words in reg. 15(3)(c) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 10(c)(iii)

Exemptions N.I.

15.—(1) These Regulations do not apply to an inactivated autogenous vaccine that is manufactured, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal and used for the treatment of that animal.

(2) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to an inactivated autogenous vaccine that is—

(a) manufactured by a person and in premises authorised in accordance with Part 2 of Schedule 2, on the instructions of a veterinary surgeon, from pathogens or antigens obtained from an animal; and

(b) used for the treatment of—

(i) other animals on the same site;

(ii) animals intended to be sent to those premises; or

(iii) animals on a site that receives animals from those premises.

(3) Schedule 1 and Part 1 of Schedule 2 do not apply in relation to—

(a) blood or blood constituents from a blood bank authorised in accordance with Part 3 of Schedule 2;

(b) a product manufactured for administration under the cascade by a person and in premises authorised in accordance with Part 4 of Schedule 2; or

(c) equine stem cell products for use as an autologous treatment for horses from an equine collection centre authorised in accordance with Part 5 of Schedule 2.

(4) Schedule 6 (exemptions for small pet animals) has effect.

Extent Information

E10 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Fees U.K.

16.  Schedule 7 (fees) has effect.

(1)

If the manufacture is carried out in the United Kingdom the manufacturer must hold a manufacturing authorisation for that type of product granted by the Secretary of State.

(2)

For provisions on breaking open packages see regulation 7(3).