# The Veterinary Medicines Regulations 2013, Paragraph 2A: Information with the application: format

Extent: E+W+S

(1) An application must be submitted electronically.
(2) Subject to sub-paragraph (3), the application must be structured as a single dossier in four parts—
(a) Part 1 (administrative information);
(b) Part 2 (pharmaceutical quality (physicochemical, biological or microbiological) data);
(c) Part 3 (safety documentation, including safety and residue tests);
(d) Part 4 (efficacy documentation, including pre-clinical studies and clinical trials).
(3) An application concerning the release of GMOs must set out the environmental risk assessment in respect of that release as a separate document, and that assessment must be presented in accordance with the following provision of the GMO Deliberate Release Regulations—
(a) as regards England or Scotland, regulation 6;
(b) as regards Wales, regulation 7.

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/1/paragraph/2A (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-1/paragraph-2A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.