The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 No. 1488

SCHEDULES

SCHEDULE 2 Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 13 Amendment of Part 14 (amendment of Part 13 (packaging and leaflets))

162.  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.”.”.