Paragraph 162 I1

After regulation 207 (amendment of regulation 268 (offence relating to packaging and package leaflets)) insert—

“Insertion of new regulation 268A (offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc)

207A

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.”.”.