# The Medicines (Veterinary Medicinal Products) (Applications for Product Licences) Regulations 1993, Paragraph 3: Requirements


(1) Subject to sub-paragraphs (2) and (3) below, the applicant shall comply with the requirements set out in Part 6 (analytical (physico-chemical, biological or microbiological) tests).
(2) Where at the request of the applicant a manufacturer of an active ingredient of the product submits details concerning the method of manufacture, quality control during manufacture and process validation directly to the licensing authority, the applicant shall obtain from the manufacturer—
(a) all the data necessary for him to take responsibility for the product,
(b) written confirmation that the manufacturer will ensure batch to batch consistency and inform the applicant before he modifies the manufacturing process or specifications, and
(c) written confirmation that the manufacturer will supply to the licensing authority all documents and particulars which may be required by the authority relating to any such modification,
and shall submit the data and confirmations received to the licensing authority.
(3) Where the applicant refers to a specification in a monograph in a pharmacopoeia but the licensing authority considers that such specification is insufficient to ensure the quality of the product, the applicant shall submit to the authority on request a more appropriate specification.

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Source: https://www.legislation.gov.uk/uksi/1993/2398/schedule/2/paragraph/3 (the official version)
Page: https://openlegislation.uk/medicines-veterinary-medicinal-products-applications-for-product-licences-regulations-1993/schedule-2/paragraph-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.