Paragraph 4 Approval of the active substanceE1

England, Wales and Scotland

(1)

The Secretary of State may approve an active substance for use in a veterinary medicinal product manufactured under this Schedule.

(2)

The Secretary of State may not grant an approval if the active substance requires veterinary control.

(3)

The approval must specify the species of animals for which it is approved, and may specify how the active substance or a product containing it is to be administered.

(4)

The Secretary of State may suspend or revoke the approval (or limit it to a smaller number of species) if—

(a)

it is demonstrated that the substance requires veterinary control;

(b)

F1adverse events are reported making suspension or revocation necessary; or

(c)

it is demonstrated that the substance—

(i)

is carcinogenic;

(ii)

is genotoxic; or

(iii)

shows developmental toxicity (including teratogenicity).

(5)

The procedure for the refusal, suspension or revocation of an approval under this paragraph is the same as the procedure for a marketing authorisation.

Annotations

Textual amendments

F1: Words in Sch. 6 para. 4(4)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 158

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