Medicines Act · 2024 Revised Edition · Part · Registration and Licensing
18. Exemptions and savings
Official textFrom Attorney General's Chambers, unchanged
The Authority may exempt from the provisions of section 10(1), any person who wishing to import any medicinal product for the purpose of research in a school of pharmacy or a research or training institution or in order to obtain samples solely for the purpose of registration.
Authority
“Authority” means the Brunei Darussalam Medicines Control Authority established under section 5;
The requirement of section 10(1) as regards a licence to manufacture or supply does not apply to the dispensing, or the doing of any act falling within the definition of “manufacture” in section 2(1) which is necessary for the dispensing, of any medicine for the purpose of its being used for medical treatment by the following persons and in the following circumstances —
a pharmacist or a person working under the immediate personal supervision of a pharmacist in a retail pharmacy; and
a person acting in the course of his duties under the supervision of a pharmacist who is employed in a hospital or dispensary maintained by the public or private sector, or out of public funds, or by an approved charity.
Section 10(1)(a) does not apply to any medicine manufactured by a person and in the circumstances described in subsection (2) if it was manufactured for the purpose of dispensing.
medicine
“medicine” means any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a “medicine”;
The Authority may exempt from the provisions of section 10(1), any school of pharmacy or a research or training institution wishing to manufacture any medicinal product for teaching or research purposes.
medicinal product
“medicinal product” has the meaning ascribed to it by section 4;
The Authority may exempt from the provisions of section 10(1), any person wishing to manufacture any medicinal product solely for the purpose of producing samples for clinical trials or for registration under this
Act.
The Authority may exempt from the provisions of section 10(1)
any person wishing to manufacture or import any medicinal product solely
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for the purpose of treatment of any person suffering from a life-threatening illness.
treatment
“treatment”, in relation to disease, includes anything done or provided for alleviating the effects of the disease, whether it is done or provided by way of cure or not;
Terms defined in s 2
Authority
Defined · s 2“Authority” means the Brunei Darussalam Medicines Control Authority established under section 5;
hospital
Defined · s 2“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;
medicinal product
Defined · s 2“medicinal product” has the meaning ascribed to it by section 4;
medicine
Defined · s 2“medicine” means any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals is likewise considered a “medicine”;
pharmacist
Defined · s 2“pharmacist” means a person registered under the Pharmacists Registration Order, 2001;
treatment
Defined · s 2“treatment”, in relation to disease, includes anything done or provided for alleviating the effects of the disease, whether it is done or provided by way of cure or not;
Part
Clinical Trials
Part
Sales and Other Dealings of Medicinal Products
Part
Pharmacies
Part
Containers, Packages and Identification of Medicinal Products
Part
Promotion of Sales of Medicinal Products and Medical Advertisements
Part