SCHEDULE 6Exemptions for small pet animals

Approval of the active substance4

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.