# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 207: Amendment of regulation 268 (offence relating to packaging and package leaflets)

Extent: E+W+S+N.I.

(1) Regulation 268 is amended as follows.
(1A) In the heading to the regulation, after “packaging and package leaflets” insert “in Great Britain”.
(2) In paragraph (1)—
(a) for “marketing authorisation, Article 126a authorisation” substitute “UKMA(UK), UKMA(GB)”;
(b) after “the purpose of sale or supply” insert “, in Northern Ireland”.
(3) In paragraph (2)(a)—
(a) for “Article 28 or 32 of the Paediatric Regulation” substitute “ regulation 50C(4), 50D(8) or 58A(2)(b) ”; and
(b) omit “, Article 9 of Commission Regulation 2016/161”.

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Source: https://www.legislation.gov.uk/uksi/2019/775/regulation/207 (the official version)
Page: https://openlegislation.uk/human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-207
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.