(1) A person shall not manufacture, prepare, import, export, distribute, sell, supply or exhibit for sale a drug, herbal medicinal product, cosmetic, medical device or household chemical substance unless the article has been registered by the Authority.

(2) Subsection (1) does not apply to an import permit issued by the Authority for the importation of any of the articles mentioned in that subsection which is imported for personal use.

(3) Subsection (1) does not prevent the importation of a sample for purposes of registration of the drug, herbal medicinal product, cosmetic, medical device or household chemical substance.

(4) The Authority may approve the registration of a drug, herbal medicinal product, medical device or household chemical substance subject to the conditions that it may impose where

(a) a person makes an application for the registration of the drug, herbal medicinal product, medical device or household chemical substance, and

(b) the Authority conducts the necessary investigation and is satisfied that it is suitable for the purpose for which it is intended and that it complies with the prescribed requirements.

(5) Where the Authority

(a) refuses to approve the registration of a drug, herbal medicinal product, cosmetic, medical device or household chemical substance, or

(b) approves registration of the products subject to the conditions specified under subsection (4) the Chief Executive Officer shall inform the applicant in writing of the decision and the reasons for the decision within thirty day of the refusal or approval.

(6) Without limiting subsection (4),

(a) where the applicant is not satisfied with the decision of the Authority, the applicant may make representations to the Authority within sixty days after the date of the notification; and

(b) where the Authority is satisfied with the representations submitted, it may approve the registration of the drug, cosmetic, herbal medicinal product, medical device, household chemical substance or if it is still not satisfied it shall reject the application.

(7) Where the Authority approves the registration of a drug, cosmetic, herbal medicinal product, medical device or household chemical substance the Chief Executive Officer shall

(a) enter in the register the prescribed particulars of the drug, herbal medicinal product, cosmetic, medical device or household chemical substance and the relevant conditions or particulars,

(b) allocate a registration number to the medicine, herbal medicinal product, cosmetic, medical device or household chemical substance for a period of not more than five years, and

(c) issue to the applicant a certificate of registration in the prescribed form showing the registration number of the drug, herbal medicinal product, cosmetic, medical device or house chemical substance and the conditions subject to which it is registered.

(8) Despite the proposed name of the applicant, the Authority may reject a name on the grounds that

(a) it constitutes a safety hazard,

(b) it is misleading,

(c) it is established or based on international non-proprietary names, or

(d) it stems from a related substance or for any other sufficient reason determined by the Authority and register the product under a name approved by the Authority.