# The Veterinary Medicines Regulations 2013, Paragraph 4: Approval of the active substance

Extent: E+W+S

(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) adverse 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.

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/6/paragraph/4 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-6/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.