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Paragraph 38 Suspension , revocation, etc of a marketing authorisation: groundsF3E1

England, Wales and Scotland

F1(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.

F2(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

Annotations

Textual amendments

F1

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)

F2

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)

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)

Extent

E1

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

Notes on Schedule 1

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)