# The Human Medicines Regulations 2012, Regulation 257: Packaging requirements: general


(1) The information specified in Part 1 of Schedule 24 must appear—
(a) on the outer packaging of a medicinal product; and
(b) on the immediate packaging of the product, unless paragraph (2) or (3) applies to the packaging.
(2) This paragraph applies to immediate packaging if the packaging is in the form of a blister pack and is placed in outer packaging which complies with the requirements of Part 1 of Schedule 24.
(3) This paragraph applies to immediate packaging if the packaging is too small to display the information required by Part 1 of Schedule 24.
(4) The information specified in Part 2 of Schedule 24 must appear on immediate packaging to which paragraph (2) applies.
(5) The information specified in Part 3 of Schedule 24 must appear on immediate packaging to which paragraph (3) applies.
(6) Information included on the packaging of a product in accordance with this regulation, regulation 257C ..., regulation 261 and Schedule 24 must be easily legible, comprehensible and indelible.
(7) Nothing in this regulation or Schedule 24 applies to a registrable homoeopathic medicinal product.
(8) Nothing in this regulation applies to the outer or immediate packaging of an advanced therapy medicinal product ....
(9) This regulation is subject to regulation 257AA.
(10) Nothing in this regulation applies to a POC medicinal product that is the subject of a UKMA(UK)(Category 1).

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/257 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-257
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.