Medicines Act · 2024 Revised Edition · Part · Preliminary
4. Meaning of “medicinal product” and related expressions
Official textFrom Attorney General's Chambers, unchanged
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 —
medicinal product
“medicinal product” has the meaning ascribed to it by section 4;
use by being administered to one or more human beings or animals for a medicinal purpose;
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.
Medicines
In this Act, “a medicinal purpose” means any one or more of the following purposes —
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 terminating, reducing or postponing, or increasing or accelerating, the operation of that function or in any other way.
Notwithstanding anything in 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 —
substance
“substance” means any natural or artificial substance whether in solid or liquid form or in the form of gas or vapour;
in the course of the business of the manufacturer or on behalf of the manufacturer in the course of the business of laboratory or research established carried on by another person;
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), (b) and (c).
In this Act, “medicinal product” does not include —
substances used in dental surgery for filling dental cavities;
bandages and other surgical dressings, except medicated dressings where the medication has a palliative or
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curative function which is not limited to sterilising the dressings;
substances and articles of such other description or classes as may be specified by order made by the Minister.
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 shall 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 the use wholly or mainly in a way other than those specified in subsection (1).
For the purposes of this Act, medicinal products are of the same description if —
they are manufactured to the same specification;
manufacturing methods and processes; equipment and manufacturing plant; and
they are, are to be, sold, supplied, imported or exported in the same pharmaceutical form.
For the purposes of this Act, a document, advertisement or representation shall be taken to be likely to mislead as the uses or effects of medicinal products of a particular description if it is likely to mislead as to any of the following matters —
representation
“representation” means any statement or undertaking (whether constituting a condition or a warranty or not) which consists of spoken words falling within paragraph (a) or (b) of the definition of “advertisement”.
any purposes for which medicinal products of that description can with reasonable safety be used;
any purposes for which such products cannot be so used; and
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.
Medicines
Terms defined in this Act
disease
Defined · s 2“disease” includes any injury, ailment or adverse condition, whether of body or mind;
ingredient
Defined · s 2“ingredient”, in relation to manufacture or preparation of a product, includes any substance of that product as manufactured or prepared;
medicinal product
Defined · s 2“medicinal product” has the meaning ascribed to it by section 4;
representation
Defined · s 51“representation” means any statement or undertaking (whether constituting a condition or a warranty or not) which consists of spoken words falling within paragraph (a) or (b) of the definition of “advertisement”.
substance
Defined · s 2“substance” means any natural or artificial substance whether in solid or liquid form or in the form of gas or vapour;
Part
Brunei Darussalam Medicines Control Authority
Part
Registration and Licensing
Part
Clinical Trials
Part
Sales and Other Dealings of Medicinal Products
Part
Pharmacies
Part
Containers, Packages and Identification of Medicinal Products
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Promotion of Sales of Medicinal Products and Medical Advertisements
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