OpenLegislation

Paragraph 5 Suspension, revocation etc of the authorisationF4E1

England, Wales and Scotland

(1)

The Secretary of State may suspend, vary or revoke a manufacturing authorisation if the holder—

(a)

has not complied with these Regulations;

(b)

has manufactured a veterinary medicinal product not authorised by the manufacturing authorisation;

(c)

has produced a veterinary medicinal product outside the terms of a marketing authorisation; F1...

(d)

no longer has suitable premises or equipment.

F2(e)

has failed to carry out the activity specified in the authorisation for a period of five years or more; or

(f)

has not paid any fee required under these Regulations

F3(2)

The Secretary of State may also suspend, vary or revoke the authorisation on being satisfied that the qualified person (manufacture), the person responsible for quality control or the person with responsibility for production is not fulfilling that person’s duties under these Regulations.

(3)

In particular, the Secretary of State may—

(a)

suspend the manufacture or import of veterinary medicinal products;

(b)

suspend, revoke or vary the manufacturing authorisation for one or more pharmaceutical forms;

(c)

suspend, revoke or vary the manufacturing authorisation for one or more activities in one or more manufacturing sites.

Annotations

Textual amendments

F1

Word in Sch. 2 para. 5(1) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 85(a)(i)

F2

Sch. 2 para. 5(1)(e)(f) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 85(a)(ii)

F3

Sch. 2 para. 5(2)(3) substituted for Sch. 2 para. 5(2) (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 85(b)

F4

Words in Sch. 2 para. 5 heading substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 85(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