SCHEDULE 6U.K.Exemptions for small pet animals

Approval of the active substanceE+W+S

4.—(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.

Approval of the active substanceN.I.

4.—(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)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).

(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.