Paragraph 4 Approval of the active substanceI1

United Kingdom

(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 must grant an approval if he is satisfied that the substance does not require veterinary control.

(3)

The approval must specify the animals for which it is approved, and may specify how it 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)

serious adverse reactions 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).

Annotations