# The Human Medicines Regulations 2012, Regulation 264: Homoeopathic medicines


(1) The outer packaging and immediate packaging and, where a package leaflet is included, the package leaflet of a homoeopathic medicinal product must clearly include the words “homoeopathic medicinal product”.
(2) The outer packaging and immediate packaging and, where a package leaflet is included, the package leaflet of a registrable homoeopathic medicinal product must also include the information specified in paragraph (1) and Part 1 of Schedule 28 and no other information (unless paragraph (5) or (6) applies).
(3) Regulation (4) applies in a case where a package leaflet is not included with a registrable homoeopathic medicinal product.
(4) Unless the context requires otherwise, any requirement of these Regulations that is expressed by reference to a package leaflet shall be taken to refer to—
(a) the outer packaging or the immediate packaging of the product; or
(b) in a case to which paragraph (5) or paragraph (6) applies, the outer packaging of the product.
(5) Where the immediate packaging of a registrable homoeopathic medicinal product is in the form of a blister pack and is placed in outer packaging which complies with the requirements of this regulation and Part 1 of Schedule 28, the immediate packaging must include the information specified in this regulation and Part 2 of Schedule 28.
(6) Where the immediate packaging of a registrable homoeopathic medicinal product is too small to display the information required by Part 1 of Schedule 28, the immediate packaging must include the information specified in this regulation and Part 3 of Schedule 28.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/264 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-264
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.