# The Human Medicines Regulations 2012, Regulation 257AA: Packaging requirements: variation in accordance with regulation 68(11I)


(1) This regulation applies where, in accordance with regulation 68(11I), the licensing authority thinks that a variation is necessary so that a UKMA(UK)(Category 2) is treated as a UKMA(GB) and separate UKMA(NI).
(2) Where this regulation applies, the licensing authority may require that, in relation to the UKMA(GB), the information specified in paragraph 18B of Schedule 24 is replaced with a statement that the medicinal product is for sale or supply in Great Britain only.

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