Regulation 207A Insertion of new regulation 268A (offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc)F1I1

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.”.