# The Veterinary Medicines Regulations 2013, Paragraph 22: Grant of a marketing authorisation

Extent: E+W+S+N.I.

(1) The Secretary of State must, before granting a marketing authorisation—
(a) verify that the data submitted complies with the requirements set out in these Regulations;
(b) assess the application and data submitted in respect of the veterinary medicinal product; and
(c) reach a conclusion in relation to the benefit-risk balance of granting a marketing authorisation in respect of the veterinary medicinal product.
(2) When granting a marketing authorisation, the Secretary of State must inform the applicant of the summary of product characteristics that has been approved, and the distribution category of the product.
(3) The Secretary of State must set out any terms and conditions in connection with placing the product on the market when granting a marketing authorisation.
(4) Where the marketing authorisation relates to a veterinary medicinal product that contains an antimicrobial the Secretary of State may require the holder of the marketing authorisation to conduct post-authorisation studies in order to ensure that the benefit-risk balance remains positive in relation to the development of antimicrobial resistance.

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/22 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-22
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.