269.—(1) This regulation applies to a person, other than the holder of a [F2UKMA(UK), UKMA(GB)], certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business [F3carried on by that person,] sells or supplies, or offers to sell or supply the product, or possesses the product for the purpose of sale or supply [F4, in Great Britain].
(2) A person to whom this regulation applies is guilty of an offence if the person sells or supplies, or offers to sell or supply, the product, or possesses the product for the purpose of sale or supply, [F5in Great Britain] knowing or having reasonable cause to believe—
(a)that a package or package leaflet relating to the medicinal product does not comply with the applicable requirements of this Part F6... or [F7regulation 50C(4), 50D(8) or 58A(2)(b)]; or
(b)that the product is not accompanied by a package leaflet when one is required by virtue of this Part.
Textual Amendments
F1Words in reg. 269 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 208(1A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(a)); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in reg. 269(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 208(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(b)); 2020 c. 1, Sch. 5 para. 1(1)
F3Words in reg. 269(1) inserted (E.W.S.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.I. 2015/903), regs. 1, 7 and words in reg. 269(1) inserted (N.I.) (1.7.2015) by The Human Medicines (Amendment) (No. 2) Regulations 2015 (S.R. 2015/259), regs. 1, 7
F4Words in reg. 269(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 208(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(b)); ; 2020 c. 1, Sch. 5 para. 1(1)
F5Words in eg. 269(2) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 208(2A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 163(c)); 2020 c. 1, Sch. 5 para. 1(1)
F6Words in reg. 269(2)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 208(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F7Words in reg. 269(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 208(3)(a); 2020 c. 1, Sch. 5 para. 1(1)