# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 207A: Insertion of new regulation 268A (offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc)


After regulation 268 insert—
“Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc
268A. (1) This regulation applies to the holder of a UKMA(UK), UKMA(NI), EU marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product who sells or supplies, offers to sell or supply, or possesses for the purpose of sale or supply, in Northern Ireland, a medicinal product to which the authorisation, certificate or registration relates.
(2) A person to whom this regulation applies is guilty of an offence if—
(a) a package or package leaflet relating to the product does not comply with the applicable requirements of this Part, Article 9 of Commission Regulation 2016/161 or Article 28 or 32 of the Paediatric Regulation; or
(b) the product is not accompanied by a package leaflet when one is required by virtue of this Part.”.

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