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The Human Medicines Regulations 2012
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Changes over time for: Section 273
Version Superseded: 31/12/2020
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- 14/08/2012- Amendment
- 31/03/2014
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Child resistant containers for regulated medicinal productsU.K.
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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 11th May 2005; or
(b)any equivalent or higher technical specification for reclosable child resistant packaging recognised for use in the European Economic Area.
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