The Secretary of State and the Department of Health, Social Services and Public Safety, acting jointly, make the following Regulations in exercise of the powers conferred on them by section 1(1) and (2) of the Medicines Act 19711 or, in the case of the Department, the powers conferred by those provisions and now vested in it2.

In so far as these Regulations are not made under section 1(1) and (2) of the Medicines Act 1971, the Secretary of State makes these Regulations in exercise of the powers conferred on her by section 2(2) of the European Communities Act 19723 and section 56(1) and (2) of the Finance Act 19734. The Secretary of State has been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to medicinal products5 and medical devices6.

The Treasury has consented to the making of these Regulations as required by section 1(1) of the Medicines Act 1971 and section 56(1) of the Finance Act 1973.

In accordance with section 129(6) of the Medicines Act 19687, the Secretary of State and the Department of Health, Social Services and Public Safety Development have consulted with such organisations as appear to them to be representative of interests likely to be substantially affected by these Regulations.