(1) Subject to the following provisions of this section, in this Act "medicinal product" means any substance or article (not being an instrument, apparatus or appliance) which is manufactured, sold, supplied, imported or exported for use wholly or mainly in either or both of the following ways, that is to say -

• use by being administered to one or more human beings or animals for a medicinal purpose;
• use, in circumstances to which this paragraph applies, as an ingredient in the preparation of a substance or article which is to be administered to one or more human beings or animals for a medicinal purpose.

2) In this Act "a medicinal purpose" means any one or more of the following purposes, that is to say -

• treating or preventing disease;
• diagnosing disease or ascertaining the existence, degree or extent of a physiological condition;
• contraception
• inducing anaesthesia;
• otherwise preventing or interfering with the normal operation of a physiological function, whether permanently or temporarily, and whether by way of terminating, reducing or postponing, or increasing or accelerating the operation of that function or in any other way.

3) In paragraph (b) of subsection (1) of this section the reference to use in circumstances to which that paragraph applies is a reference to any one or more of the following, that is to say -

• use in a pharmacy or in a hospital;
• use by a practitioner;
• use in the course of a business which consists of or includes the retail sale, or the supply in circumstances corresponding to retail sale, of herbal remedies.

4) Notwithstanding anything in subsection (1) of this section in this Act "medicinal product" does not include any substance or article which is manufactured for use wholly or mainly by being administered to one or more human beings or animals, where it is to be administered to them -

• in the course of the business of the person who has manufactured it (in this subsection referred to as the manufacturer), or on behalf of the manufacturer in the course of the business of a laboratory or research establishment carried on by another person, and
• solely by way of a test for ascertaining what effects it has when so administered, and
• in circumstances where the manufacturer has no knowledge of any evidence that those effects are likely to be beneficial to those human beings, or beneficial to, or otherwise advantageous in relation to, those animals, as the case may be,

and which (having been so manufactured) is not sold, supplied or exported for use wholly or mainly in any way not fulfilling all the conditions specified in paragraphs (a) to (c) of this subsection.

ANNEX II

Commercially available Controlled Drugs