(1)  Before a new drug is first offered for sale to the public, the manufacturer, importer, or distributor (as the case may require) of the new drug shall make application to the Minister –

(a) to classify the new drug by determining the schedule (if any) to the Poisons List in which the drug is to be specified; and

(b) to determine whether substances containing more or less than a specified percentage by weight or volume of that drug are to be excluded from, or included in, any of the schedules to the Poisons List.

(2)  On receipt of an application under this section, the Minister –

(a) shall forthwith determine whether it is necessary to include the drug to which the application relates in a schedule to the Poisons List and, if he determines that it is necessary to include the drug in that List, shall determine in which of those schedules the drug should be included;

(b) if it appears to the Minister to be necessary to do so, may make a determination under subsection (1) (b) ; and

(c) is to make any order under section 14 as may be necessary for the purpose of giving effect to his or her determination.

(3)  In making a determination under subsection (2) (a) , the Minister shall have regard to whether or not the drug is included in any classification of poisons made by the National Health and Medical Research Council.

(4)  .  .  .  .  .  .  .  .  

(5)  The Minister shall cause his determination under subsection (2) with respect to an application under this section to be notified to the applicant in writing.

(6)  A determination by the Minister under subsection (2) is final and conclusive.

(7)  .  .  .  .  .  .  .  .