The Human Medicines Regulations 2012

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

[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

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

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

[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

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

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