Medicines Act · 2024 Revised Edition · Part · Registration and Licensing
11. Registration of medicinal products
Official textFrom Attorney General's Chambers, unchanged
The Authority may, on application made in such manner and form as it may require, register any medicinal product subject to such conditions as it may impose.
Authority
“Authority” means the Brunei Darussalam Medicines Control Authority established under section 5;
Every application for the registration of a medicinal product shall be accompanied by —
medicinal product
“medicinal product” has the meaning ascribed to it by section 4;
the prescribed processing fee for that type of product; and
such documents, items, samples, particulars and other information as the Authority may require.
The Authority may charge an applicant such costs as it may incur for the purposes of carrying out any laboratory investigation prior to the registration of the medicinal product.
The processing fee and such costs as may be charged by the
Authority under subsection (3) shall not be refundable.
Any change in any document, item, sample, particulars or other information mentioned in subsection (2)(b) shall be notified in writing by the applicant to the Authority within 14 days from the date of such change.
Subject to section 20, the period of registration of a medicinal product shall be as specified in the product licence issued under subsection (8) and where so specified the registration shall be valid till the end of the specified period.
product licence
“product licence” has the meaning ascribed to it by sections 11 and 15, and includes any provisional licence under section 17;
Subject to section 20, where the period of registration of a medicinal product is not specified the registration shall be valid until it is cancelled.
Medicines
Upon registration of a medicinal product, the Authority shall issue to the applicant a product licence.
Any person who knowingly supplies any false or misleading information to the Authority in connection with an application for the registration of a medicinal product is guilty of an offence.
Terms defined in s 2
Authority
Defined · s 2“Authority” means the Brunei Darussalam Medicines Control Authority established under section 5;
medicinal product
Defined · s 2“medicinal product” has the meaning ascribed to it by section 4;
product licence
Defined · s 2“product licence” has the meaning ascribed to it by sections 11 and 15, and includes any provisional licence under section 17;
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