# The Veterinary Medicines Regulations 2013, Paragraph 7: Bibliographic application

Extent: E+W+S

(1) An applicant for a marketing authorisation need not provide the results of safety tests, residue tests, pre-clinical trials or clinical trials if the applicant demonstrates that the active substances of the veterinary medicinal product have been in well-established veterinary use for at least 10 years, that their efficacy is documented and that they provide an acceptable level of safety.
(1A) Sub-paragraph (1) does not apply to applications for—
(a) biological (including immunological) veterinary medicinal products;
(b) novel therapies.
(2) The applicant may use any publicly available document.
(3) If an applicant makes use of scientific literature to obtain authorisation for a food-producing species, and submits, in respect of the same medicinal product and with a view to obtaining authorisation for another food-producing species, new residue studies, together with further clinical trials, a third party may not use those studies or trials in an application for a pharmacologically equivalent product for a period of three years from the grant of the authorisation for the additional species.

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/7 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.