The Medicines (Child Safety) Regulations 2003

Explanatory Note

(This note is not part of the Regulations)

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(1), as amended(2).

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.

(1)

OJ No. L 204, 21.7.1998, p. 37.

(2)

See Directive 98/48/EC (OJ No. L 217, 5.8.1998, p. 18).