# The Veterinary Medicines Regulations 2013, Paragraph 14: Specific batch control scheme

Extent: E+W+S

(1) Where a veterinary medicinal product (other than a biological veterinary medicinal product) has been granted a marketing authorisation or an animal test certificate, and any starting material (active substance, excipient or packaging) or any batch of the product does not fully meet the requirements of the authorisation or animal test certificate, the holder may apply to the Secretary of State to place one or more batches on the market notwithstanding this.
(2) The Secretary of State may authorise the placing on the market on being satisfied that the safety, quality and efficacy of the product are not compromised, and that in all the circumstances of the case the product should be placed on the market.
(3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/14 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-14
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.