Explanatory note

This Order extends the application of specified provisions of the Medicines Act 1968 to the substances gentamicin, neomycin and nystatin, in circumstances where those substances are not in themselves medicinal products but are used as ingredients in the manufacture of medicinal products (Article 3(1)). Those substances are specified in Schedule 1 and defined in Schedule 2 to this Order.

The provisions of the Act which are applied to those substances by this Order relate to the holding of licences, the regulation of dealings with such substances, the commission of offences, requirements relating to containers and packages, and certain miscellaneous matters.

Those provisions already apply to gentamicin and neomycin in circumstances where they are for use as ingredients in medicinal products to be administered by parenteral injection, by virtue of the Medicines (Control of Substances for Manufacture) Order 1971 (S.I. 1971/1200). This Order applies those provisions to gentamicin and neomycin in circumstances where they are for use as ingredients in medicinal products which are to be administered by other means; further, it applies those provisions to nystatin in circumstances where that substance is for use as an ingredient in a medicinal product which is to be administered in any way.

This Order also modifies specified provisions of the Act, in the circumstances in which the Order applies, so as to provide for a transitional period of exemption before the provisions of the Act requiring the holding of licences shall have full effect (Article 3(2)).