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Regulation 268A Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etcF1

(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 F2... 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.

Annotations

Textual amendments

F1

Reg. 268A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 207A (as inserted by S.I. 2020/1488, reg. 1, Sch. 2 para. 162); 2020 c. 1, Sch. 5 para. 1(1)

F2

Words in reg. 268A(2)(a) omitted (1.1.2025) by virtue of The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 118