The Medicines (Child Safety) Regulations 2003
UK Statutory Instrument 2003 No. 2317 — creates 1 criminal offence.
- Made
- 6 September 2003
- In force from
- 1 October 2003
- Extent
- Not stated
- Subject
- Drugs and medicines
- Made under
- Medicines Act 1968
Explanatory note
(This note is not part of the Regulations) — published with the instrument by the department that made it. © Crown copyright, reused under the Open Government Licence v3.0.
These Regulations contain measures relating to the packaging of medicinal products consisting of or containing aspirin, paracetamol or more than 24mg of elemental iron, and a measure relating to the colouring of solid dosage forms of aspirin and paracetamol. Medicinal products that come within the scope of these Regulations have to be packaged in containers that are child resistant, which is defined with reference to two British Standards Institution standards (regulation 2). However, there are exemptions from regulation 2 for certain products dispensed by pharmacists or supplied by doctors or dentists (regulation 3). Solid dosage forms of aspirin or paracetamol have to be coloured white (regulation 4), and breaches of the requirements of these Regulations are made an offence (regulation 5). There are transitional provisions in respect of products the sale or supply of which is prohibited by these Regulations but was not prohibited by the Medicines (Child Safety) Regulations 1975 (regulation 6), and those Regulations are revoked along with the spent provisions containing the various amendments to them (regulation 7). These Regulations have been notified to the European Commission and other Member States of the European Community in accordance with Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision of information in the field of technical standards and regulations and rules on Information Society services, as amended. A Regulatory Impact Assessment in relation to these Regulations has been placed in the libraries of both Houses of Parliament, and copies can be obtained from the Medicines and Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ. The British Standards referred to in these Regulations may be obtained from any of the sales outlets operated by the British Standards Institution or by post from the British Standards Institution at Linford Wood, Milton Keynes MK14 6LE.
Offences created by this instrument
- Any person who contravenes section 87(2) of the Medicines Act 1968 by contravening any requirement imposed by these… regulation 5 · Status not determined · Strict liability
What Parliament said about it
Hansard was searched for this instrument by name and returned nothing. That is the ordinary outcome: an instrument laid under the negative procedure is usually never debated, and becomes law without a word said about it in either House.
How Parliament handled it
Parliament's Statutory Instruments service records procedure from May 2017 onwards, and this instrument predates it. That is a limit of the source, not a statement that nothing happened.
Check the source
- This instrument on legislation.gov.uk The authoritative text, including amendments made since
- Other instruments from 2003