# The Human Medicines Regulations 2012, Paragraph 16


(1) Subject to sub-paragraph (2), a mock-up, in accordance with Part 13 (packaging and leaflets) of—
(a) the outer packaging of the medicinal product;
(b) the immediate packaging of the medicinal product; and
(c) the package leaflet for the medicinal product.
(2) Sub-paragraph (1)(a) and (b) does not apply to an application for a marketing authorisation for a POC medicinal product which is (or is in a form which means a dose or part of it is) to be administered immediately after manufacture.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/8/paragraph/16 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-8/paragraph-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.