# The Veterinary Medicines Regulations 2013, Paragraph 20: Authorisation in relation to products for administration under the cascade

Extent: E+W+S

(1) Subject to sub-paragraph (2), no person may manufacture a product for administration under the cascade that is the pharmaceutical equivalent of an authorised veterinary medicinal product.
(2) The Secretary of State may authorise the manufacture of a product notwithstanding sub-paragraph (1) where there is difficulty in relation to the supply of the authorised veterinary medicinal product.
(3) The holder of an authorisation under paragraph 14(1)(a)(ii) may not supply a product manufactured in accordance with that sub-paragraph other than to a veterinary surgeon who has prescribed the product under the cascade.
(4) The holder of an authorisation under paragraph 14(1)(a)(ii) must—
(a) provide a list of products manufactured in accordance with that sub-paragraph to the Secretary of State annually or at the request of the Secretary of State;
(b) provide sales data for products supplied under sub-paragraph (3) at the request of the Secretary of State.
(5) For the purposes of this paragraph, a product is the pharmaceutical equivalent of an authorised veterinary medicinal product if—
(a) it has the same qualitative and quantitative composition in active substances; and
(b) it has the same pharmaceutical form.

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/2/paragraph/20 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-2/paragraph-20
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.