Regulation 268 Offence relating to packaging and package leaflets in Great Britain: holder of authorisation etcF5

United Kingdom

(1)

This regulation applies to the holder of a F1UKMA(UK), UKMA(GB), 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 F2, 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 F3... or F4regulation 50C(4), 50D(8) or 58A(2)(b); or

(b)

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. 268(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 207(2)(a) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(b)); 2020 c. 1, Sch. 5 para. 1(1)
F2: Words in reg. 268(1) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 207(2)(b) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(b)); 2020 c. 1, Sch. 5 para. 1(1)
F3: Words in reg. 268(2)(a) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 207(3)(b); 2020 c. 1, Sch. 5 para. 1(1)
F4: Words in reg. 268(2)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 207(3)(a); 2020 c. 1, Sch. 5 para. 1(1)
F5: Words in reg. 268 heading inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 207(1A) (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 161(a)); 2020 c. 1, Sch. 5 para. 1(1)