# The Veterinary Medicines Regulations 2013, Paragraph 11: Duties on a qualified person

Extent: E+W+S

(1) The qualified person (manufacture) must ensure that each batch of veterinary medicinal product manufactured under that person’s responsibility is manufactured and checked in compliance with these Regulations and in accordance with the data submitted in support of the application for the marketing authorisation.
(2) If a manufacturer imports a veterinary medicinal product from another country,..., the qualified person (manufacture) must ensure that, following importation, each production batch imported is fully tested ..., including a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or controls necessary to ensure the quality of a veterinary medicinal product is in accordance with the requirements of the marketing authorisation.
(3) Sub-paragraph (2) does not apply where the exporting country has demonstrated equivalent standards to those of the United Kingdom or where appropriate arrangements have been made ...with the exporting country to ensure that the manufacturer of the veterinary medicinal product applies standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/412/EEC and to ensure that the controls in sub‑paragraph (2) have been carried out in the exporting country.
(4) At each stage of manufacture, including release for sale, the qualified person (manufacture) must certify in writing that all control tests required under the marketing authorisation have been carried out, and that the production batch complies with the marketing authorisation.

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Source: https://www.legislation.gov.uk/uksi/2013/2033/schedule/2/paragraph/11 (the official version)
Page: https://openlegislation.uk/veterinary-medicines-regulations-2013/schedule-2/paragraph-11
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.