# The Human Medicines Regulations 2012, Paragraph 13


Where—
(a) animals are used in the production of medicinal products; and
(b) in the case of a product for sale or supply—
(i) in Great Britain, a UK marketing authorisation, certificate of registration or traditional herbal registration, or
(ii) in Northern Ireland, a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration,
contains provisions relating to them,
the manufacturer's licence holder must arrange for the animals to be housed in such premises, and managed in such a manner, as facilitates compliance with those provisions.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/4/paragraph/13 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-4/paragraph-13
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

