The Veterinary Medicines Regulations 2013 No. 2033

SCHEDULE 1 U.K. Marketing authorisations [F1 in Great Britain] [F2 in Northern Ireland]

Textual Amendments

F1 Words in Sch. 1 heading 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(7)(a)

F2 Words in Sch. 1 heading inserted (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(13)(a)

PART 5 U.K. Suspension, etc. of a marketing authorisation

Suspension [F3 , revocation, etc] of a marketing authorisation: grounds E+W+S

38.— [F4 (1) If the Secretary of State is satisfied at any time that the benefit-risk balance of a veterinary medicinal product is not positive or is insufficient to ensure food safety, the Secretary of State may—

(a) suspend the marketing authorisation;

(b) require the holder of the marketing authorisation to submit an application for its variation;

(c) revoke the marketing authorisation.]

(2) The Secretary of State may also suspend a marketing authorisation on being satisfied that a marketing authorisation holder has failed to make an application for a variation to take account of scientific and technical progress in manufacturing and control methods to enable the veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

[F5 (3) The Secretary of State may take the steps set out in sub-paragraph (1)(a), (b) and (c) on being satisfied at any time that—

(a) information given in the application documents is incorrect;

(b) any control tests required have not been carried out;

(c) changes have been made to the manufacturing process without the authority of the Secretary of State;

(d) any information required to be supplied to the Secretary of State has not been so supplied;

(e) the holder of the marketing authorisation has failed to comply with the requirements of these Regulations;

(f) the pharmacovigilance system in relation to a veterinary medicinal product is inadequate;

(g) in the case of a generic authorisation, the reference product is updated to show a reduction in antimicrobial resistance;

(h) the qualified person (pharmacovigilance) has failed to comply with the requirements of these Regulations]

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

F3 Words in Sch. 1 para. 38 heading inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 57(c)

F4 Sch. 1 para. 38(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 57(a)

F5 Sch. 1 para. 38(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 57(b)

Suspension of a marketing authorisation: grounds N.I.

38.—(1) The Secretary of State may suspend a marketing authorisation at any time on being satisfied that —

(a) this is necessary for the protection of animal or public health or the environment;

(b) the terms of the marketing authorisation have not been complied with; or

(c) the veterinary medicinal product has insufficient therapeutic effect.

(2) The Secretary of State may also suspend a marketing authorisation on being satisfied that a marketing authorisation holder has failed to make an application for a variation to take account of scientific and technical progress in manufacturing and control methods to enable the veterinary medicinal product to be manufactured and checked by means of generally accepted scientific methods.

(3) The Secretary of State must suspend a marketing authorisation on being satisfied that—

(a) the risk-benefit balance is unfavourable;

(b) the withdrawal period does not ensure that residues in foodstuffs obtained from the treated animal comply with Regulation (EC) No 470/2009 of the European Parliament and of the Council;

(c) information given in the application documents is incorrect;

(d) any control tests required have not been carried out;

(e) changes have been made to the manufacturing process without the authority of the Secretary of State; or

(f) any information required to be supplied to the Secretary of State has not been so supplied.

Extent Information

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