Regulation 268A Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etcF1
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.
A person to whom this regulation applies is guilty of an offence if—
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
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