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Meaning of “medicinal product” and related expressions

Medicines Act 1975

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—(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:(a)use by being administered to one or more human beings or animals for a medicinal purpose;(b)use 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:(a)treating or preventing disease;(b)diagnosing disease or ascertaining the existence, degree or extent of a physiological condition;(c)contraception;(d)inducing anaesthesia;(e)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) Despite subsection (1), 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 —(a)in the course of the business of 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;(b)solely by way of a test for ascertaining what effects it has when so administered; and(c)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), (b) and (c).(4) In this Act, “medicinal product” also does not include —(a)substances used in dental surgery for filling dental cavities;(b)bandages and other surgical dressings, except medicated dressings where the medication has a palliative or curative function which is not limited to sterilising the dressings; and(c)substances and articles of such other description or classes as the Minister may specify by order.(5) Where in accordance with subsections (1) to (4) a substance or article is a medicinal product immediately after it has been manufactured, imported or exported as mentioned in subsection (1), or immediately after the first occasion on which it has been sold or supplied as mentioned in that subsection, then it does not cease to be a medicinal product for the purposes of this Act by reason only that, at any subsequent time, it is sold, supplied, imported or exported for use wholly or mainly in a way other than those specified in subsection (1).(6) For the purposes of this Act, medicinal products are of the same description if —(a)they are manufactured to the same specification; and(b)they are, or are to be, sold, supplied, imported or exported in the same pharmaceutical form,and in this Act “description”, in relation to medicinal products, is to be construed accordingly.(7) For the purposes of this Act a document, advertisement or representation is to be taken to be likely to mislead as to the uses or effects of medicinal products of a particular description if it is likely to mislead as to any of the following matters:(a)any purposes for which medicinal products of that description can with reasonable safety be used;(b)any purposes for which such products cannot be so used;(c)any effects which such products when used, or when used in any particular way referred to in the document, advertisement or representation, produce or are intended to produce.

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