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The Human Medicines Regulations 2012
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- Offerynnau Statudol y Deyrnas Unedig
- 2012 No. 1916
- PART 13
- CHAPTER 1
- Enforcement and offences
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Nodweddion Uwch
- Dangos Graddfa Ddaearyddol(e.e. Lloegr, Cymru, Yr Alban aca Gogledd Iwerddon)
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Changes over time for: Cross Heading: Enforcement and offences
Version Superseded: 01/01/2025
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Point in time view as at 01/01/2022.
Changes to legislation:
The Human Medicines Regulations 2012, Cross Heading: Enforcement and offences is up to date with all changes known to be in force on or before 13 February 2025. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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Enforcement and offencesU.K.
Offence relating to packaging and package leaflets [F1in Great Britain]: holder of authorisation etcU.K.
268.—(1) This regulation applies to the holder of a [F2UKMA(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 [F3, 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 F4... or [F5regulation 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.
Textual Amendments
F1Words 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)
F2Words 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)
F3Words 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)
F4Words 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)
F5Words 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)
[F6Offence relating to packaging and package leaflets in Northern Ireland: holder of authorisation etcU.K.
268A.—(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, Article 9 of Commission Regulation 2016/161 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.]
Textual Amendments
F6Reg. 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)
Offences relating to packaging and package leaflets [F7in Great Britain]: other personsU.K.
269.—(1) This regulation applies to a person, other than the holder of a [F8UKMA(UK), UKMA(GB)], certificate of registration or traditional herbal registration for a medicinal product, who, in the course of a business [F9carried 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 [F10, 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, [F11in 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 F12... or [F13regulation 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
F7Words 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)
F8Words 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)
F9Words 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
F10Words 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)
F11Words 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)
F12Words 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)
F13Words 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)
[F14Offences relating to packaging and package leaflets in Northern Ireland: other personsU.K.
269A.—(1) This regulation applies to a person, other than 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, in the course of a business carried 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 in Northern Ireland.
(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, in Northern Ireland 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, Article 9 of Commission Regulation 2016/161 or Article 28 or 32 of the Paediatric Regulation; or
(b)that the product is not accompanied by a package leaflet when one is required by virtue of this Part.]
Textual Amendments
F14Reg. 269A inserted (31.12.2020) by S.I. 2019/775, regs. 1, 208A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 164)
Non-compliance with requirements of this PartU.K.
270.—(1) If the holder of a [F15UK marketing authorisation, EU marketing authorisation,] Article 126a authorisation, certificate of registration or traditional herbal registration fails to comply with a requirement imposed by this Part in relation to a medicinal product, the licensing authority may give a notice to the holder requiring compliance within three months or such other period (which may be less than three months) as may be specified in the notice.
(2) If the holder fails to comply with the notice, the licensing authority may suspend the [F16UK marketing authorisation, EU marketing authorisation,] Article 126a authorisation, certificate of registration or traditional herbal registration until the holder complies with the requirements of this Part.
(3) A person who fails to comply with a notice under this regulation is guilty of an offence.
Textual Amendments
F15Words in reg. 270(1) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 209 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 165); 2020 c. 1, Sch. 5 para. 1(1)
F16Words in reg. 270(2) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 209 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 165); 2020 c. 1, Sch. 5 para. 1(1)
Offences: penaltiesU.K.
271. A person who is guilty of an offence under regulation [F17268, 268A, 269, 269A] or 270 is liable—
(a)on summary conviction to a fine not exceeding the statutory maximum; or
(b)on conviction on indictment, to a fine, to imprisonment for a term not exceeding two years, or to both.
Textual Amendments
F17Words in reg. 271 substituted (31.12.2020) by S.I. 2019/775, reg. 209A (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 166)
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