Print Options

(1) An application for the registration of a drug, herbal medicinal product, cosmetic medical device or household chemical substance shall be made to the Authority in the prescribed manner and be accompanied with the prescribed fees.

(2) The Authority shall register the drug, herbal medicinal product, medical device, cosmetic or household chemical substance if the Authority is satisfied that the drug, herbal medicinal product, medical device, cosmetic or household chemical substance complies with the prescribed standards and that the manufacturing operations for the article comply with the prescribed current code of good manufacturing practice.

(3) The Authority may charge an applicant the costs that the Authority may incur for the purposes of carrying out good manufacturing practice and inspection for laboratory investigations prior to registration of the drug, herbal medicinal product, cosmetic, medical device or household chemical substance.

(4) An application under subsection (1) may at any time be withdrawn by the applicant but the withdrawal does not entitle the applicant to the refund of the application fees.