Medicines Act

“administration” means giving or applying to a human being or an animal, whether orally, by injection or by introduction into the body in any other way, or by external application, whether by direct contact with the body or not; and any reference in this Act

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to administering a substance or article is a reference to administering it either in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, some other substance used as a vehicle;

“analysis” includes micro-biological assay;

“animal” includes any bird, fish, reptile or amphibian;

“Authority” means the Brunei Darussalam Medicines Control

Authority established under section 5;

“clinical trial” means an investigation or series of investigations on persons conducted by or under the direction and supervision of persons with scientific training or experience for the purpose of finding out about, or determining the safety, effectiveness and other effects of any product;

“clinical trial import licence” has the meaning ascribed to it by sections 11 and 15, and includes any provisional licence under section 17;

“composition”, in relation to a medicinal product, means the ingredients of which it consists and the proportions, and the degrees of strength, quality and purity, in which those ingredients are respectively contained in it;

“container”, in relation to a medicinal product, means the bottle, jar, box, packet or other receptacle which contains or is to contain it, not being a capsule, cachet or other article in which the product is or is to be administered, and where any such receptacle is or is to be contained in another such receptacle, includes the former but does not include the latter receptacle;

“contract manufacturer” means any person who manufactures any product on the order of another person to whom a manufacturer’s licence has been issued under section 15.

“cosmetic product” means any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and correcting body odours, protecting them or keeping them in good condition or all or any of those purposes;

Medicines

“dentist”

means a dentist registered under the

Medical Practitioners and Dentists Act (Chapter 112);

“disease” includes any injury, ailment or adverse condition, whether of body or mind;

“herbal remedy” means a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or comminuting or other process, or of a mixture whose ingredients are two or more substances so produced, or of a combination of such mixture with water or such other inert substances as the Authority may, by notification published in the

Gazette, specify;

“homeopathic medicine” means any pharmaceutical dosage form used in the homeopathic therapeutic system in which diseases are treated by the use of minute amounts of such substances which are capable of producing in healthy persons symptoms similar to those of the disease being treated;

“hospital” includes any institution for the reception and treatment of the sick and designated as a hospital by the Minister for the purposes of this Act;

“import licence” has the meaning ascribed to it by sections 11

and 15, and includes any provisional licence under section 17;

“indigenous medicine” means a system of treatment and prevention of disease established through traditional use of naturally occurring substances;

“ingredient”, in relation to manufacture or preparation of a product, includes any substance of that product as manufactured or prepared;

“inspector” means an inspector appointed under section 58(1);

“labelling”, in relation to a container or package of medicinal products, means affixing to or otherwise displaying on it a notice describing or otherwise relating to the contents;

“licence” means a licence issued under this Act;

“licensed importer” means a person to whom an import licence has been issued under this Act;

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“licensed manufacturer”

means a person to whom a manufacturer’s licence has been issued under this Act, and includes a contract manufacturer;

“licensed wholesaler” means a person to whom a wholesaler’s licence has been issued under this Act;

“leaflets” include any written information;

“manufacture”, in relation to any product includes —

“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 —

“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 —