Regulation 208A Insertion of new regulation 269A (offences relating to packaging and package leaflets in Northern Ireland: other persons)F1I1

After regulation 269 insert—

“Offences relating to packaging and package leaflets in Northern Ireland: other persons

269A.

(1)

This regulation applies to a person, other than 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, 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, Article 9 of Commission Regulation 2016/161 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.”.