# The Human Medicines Regulations 2012, Regulation 269A: Offences relating to packaging and package leaflets in Northern Ireland: other persons


(1) This regulation applies to a person, other than the holder of a UKMA(UK), UKMA(NI) ..., Article 126a authorisation, certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business carried on by that person, sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply in Northern Ireland.
(2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, in Northern Ireland knowing or having reasonable cause to believe—
(a) that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part ... or Article 28 or 32 of the Paediatric Regulation; or
(b) that the product is not accompanied by a package leaflet when one is required by virtue of this Part.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/269A (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-269A
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.

