Medicines Act · 2024 Revised Edition · Part · Registration and Licensing
15. Licences
Official textFrom Attorney General's Chambers, unchanged
The Authority may, subject to the provisions of this Act, issue any of the following licences and the application therefor shall be made in such form and manner, and shall contain, or be accompanied by, such documents, items, samples, particulars and other information, as the Authority may require. The following licences shall only be issued after an inspection, except a clinical trial import licence —
Authority
“Authority” means the Brunei Darussalam Medicines Control Authority established under section 5;
an import licence, authorising the licensee to import, store and sell by wholesale or supply the registered products from the premises specified in licence;
a manufacturer’s licence, authorising the licensee to manufacture the registered products in the premises specified in the licence and to sell by wholesale or supply the products;
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a wholesaler’s licence, authorising the licensee to sell by wholesale or supply the registered products from the business premises specified in the licence;
a clinical trial import licence, authorising the licensee to import one product for the purpose of clinical trials, notwithstanding that the product is not a registered product.
If medicines products are not included together in one licence, any number of registered products may be included in any licence other than a clinical trial import licence.
Subject to subsection (2), the Authority may, on application by the licensee, add to the registered products included in any licence, other than a clinical trial import licence, and make such addition or amendment to the conditions of the licence as are rendered necessary by the addition of such added products.
clinical trial import licence
“clinical trial import licence” has the meaning ascribed to it by sections 11 and 15, and includes any provisional licence under section 17;
Subject to section 20, a licence issued under this Act, other than a clinical trial import licence, shall be valid for one year.
Subject to section 20, a clinical trial import licence shall be valid for such period, not exceeding 3 years from the date of issue of the licence, as may be specified in the licence.
Every licence is not transferable to any other person.
Terms defined in s 2
Authority
Defined · s 2“Authority” means the Brunei Darussalam Medicines Control Authority established under section 5;
clinical trial import licence
Defined · s 2“clinical trial import licence” has the meaning ascribed to it by sections 11 and 15, and includes any provisional licence under section 17;
import licence
Defined · s 2“import licence” has the meaning ascribed to it by sections 11 and 15, and includes any provisional licence under section 17;
sell
Defined · s 2“sell” includes barter, and also includes offering or attempting to sell, or receiving for sale, or having in possession for sale, or exposing for sale, or sending or delivering for sale, or causing or allowing to be sold, offered or exposed for sale;
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