The Human Medicines Regulations 2012

CHAPTER 2 U.K.

Requirements relating to child safety U.K.

Interpretation U.K.

272.  In this Chapter—

“appropriate practitioner” means any of the persons described as appropriate practitioners in relation to any prescription only medicine in regulation 214(3), (5) and (6);

“regulated medicinal product” means a medicinal product containing aspirin, paracetamol or more than 24mg of elemental iron, in the form of tablets, capsules, pills, lozenges, pastilles, suppositories or oral liquids, but does not include—

(a)

effervescent tablets containing not more than 25% of aspirin or paracetamol by weight;

(b)

medicinal products in sachets or other sealed containers which hold only one dose;

(c)

medicinal products which are not intended for retail sale or for supply in circumstances corresponding to retail sale; or

(d)

medicinal products which are for export only.

Child resistant containers for regulated medicinal products U.K.

273.—(1) Regulated medicinal products sold or supplied otherwise than in accordance with regulation 274 may be sold only in containers which are—

(a) opaque or dark tinted; and

(b) child resistant.

(2) For the purposes of these Regulations, containers which are not reclosable are child resistant if they have been evaluated in accordance with, and comply with the requirements of—

(a) British Standard EN 14375:2003 published by the British Standards Institution on 18th April 2005; or

(b) any equivalent or higher technical specification for non-reclosable child resistant packaging recognised for use in the European Economic Area.

(3) For the purposes of these Regulations, containers which are reclosable are child resistant if they have been evaluated in accordance with, and comply with the requirements of—

(a) British Standard EN ISO 8317:2004 published by the British Standards Institution on 11^th May 2005; or

(b) any equivalent or higher technical specification for reclosable child resistant packaging recognised for use in the European Economic Area.

Exemptions from regulation 273 U.K.

274.—(1) Regulation 273 does not apply to the retail sale, or supply in circumstances corresponding to retail sale, of regulated medicinal products in accordance with paragraph (2).

(2) Sale or supply is in accordance with this paragraph if the sale or supply is carried out—

(a) by or under the supervision of a pharmacist;

(b) on premises which are a registered pharmacy; and

(c) either—

(i) in accordance with a prescription given by an appropriate practitioner where it is not reasonably practicable to provide the regulated medicinal products in containers that are both opaque or dark tinted and child resistant, or

(ii) at the request of a person who is aged 16 or over and specifically requests that the regulated medicinal products not be contained in a child resistant container.

(3) Regulation 273 also does not apply to the sale or supply of regulated medicinal products—

(a) by a doctor or dentist to a patient, or the patient's carer, for the patient's use;

(b) by a doctor or dentist to a person who is an appropriate practitioner, at the request of that person, for administration to a patient of that person; or

(c) in the course of the business of a hospital or health centre, where the sale or supply is for the purposes of administration, whether in the hospital or health centre or elsewhere, in accordance with the directions of an appropriate practitioner.

Colouring of aspirin and paracetamol products for children U.K.

275.  The sale or supply of a medicinal product containing aspirin or paracetamol of any colour other than white is prohibited if—

(a) it is a product for children aged 12 or under; and

(b) in the case of paracetamol, it is in a solid form (including tablets, capsules, pills, lozenges, pastilles or suppositories).

Offences U.K.

276.—(1) A person is guilty of an offence if, in the course of a business, the person sells or supplies, or possesses for the purposes of sale or supply—

(a) a regulated medicinal product in a container which does not comply with the requirements of regulation 273, unless the sale or supply is or would be exempt from those requirements under regulation 274; or

(b) a medicinal product containing aspirin or paracetamol the sale or supply of which is prohibited under regulation 275.

(2) A person guilty of an offence under this regulation 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 2 years, or to both.