The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 No. 775

PART 14 U.K. Amendment of Part 13 (packaging and leaflets)

[F1 Insertion of new regulation 268A (offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etc) U.K.

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.”.]

Textual Amendments

F1 Reg. 207A inserted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 162

Commencement Information

I1 Reg. 207A in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1