Regulation 269 Offences relating to packaging and package leaflets in Great Britain: other personsF7

United Kingdom

(1)

This regulation applies to a person, other than the holder of a F1UKMA(UK), UKMA(GB), certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business F2carried 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 F3, 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, F4in 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 F5... or F6regulation 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.

Annotations

Textual amendments

F1: Words 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)
F2: Words 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
F3: Words 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)
F4: Words 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)
F5: Words 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)
F6: Words 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)
F7: Words 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)