The Human Medicines Regulations 2012 No. 1916

PART 13 U.K. Packaging and leaflets

CHAPTER 2 U.K.

Requirements relating to child safety U.K.

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

[F1 (b) any specification for non-reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).]

(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

[F2 (b) any specification for reclosable child resistant packaging that the licensing authority is satisfied is of an equivalent or higher technical specification to that specified in sub-paragraph (a).]

Textual Amendments

F1 Reg. 273(2)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 210(2); 2020 c. 1, Sch. 5 para. 1(1)

F2 Reg. 273(3)(b) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 210(3); 2020 c. 1, Sch. 5 para. 1(1)