40Classification of new drugs

### 40 Classification of new drugs > > (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)  *\[Section 40 Subsection (2) substituted by No. 27 of 1984, s. 16 \]*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)](#GS40@Gs1@EN) [(b)](#GS40@Gs1@Hpb@EN) ; and > > > > > > > (c) [*\[Section 40 Subsection (2) amended by No. 15 of 2019, Sched. 1, Applied:28 Jun 2019\]*](/view/html/inforce/2019-06-28/act-2019-015#JS1@Ja5@GC3@EN) is to make any order under [section 14](#GS14@EN) as may be necessary for the purpose of giving effect to his or her determination. > > > (3)  *\[Section 40 Subsection (3) substituted by No. 27 of 1984, s. 16 \]**\[Section 40 Subsection (3) amended by No. 68 of 1994, s. 3 and Sched. 1 \]*In making a determination under [subsection (2)](#GS40@Gs2@EN) [(a)](#GS40@Gs2@Hpa@EN) , 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)  *\[Section 40 Subsection (4) omitted by No. 68 of 1994, s. 3 and Sched. 1 \]*.  .  .  .  .  .  .  .   > > > (5)  *\[Section 40 Subsection (5) substituted by No. 27 of 1984, s. 16 \]*The Minister shall cause his determination under [subsection (2)](#GS40@Gs2@EN) with respect to an application under this section to be notified to the applicant in writing. > > > (6)  *\[Section 40 Subsection (6) substituted by No. 27 of 1984, s. 16 \]*A determination by the Minister under [subsection (2)](#GS40@Gs2@EN) is final and conclusive. > > > (7)  *\[Section 40 Subsection (7) omitted by No. 27 of 1984, s. 16 \]*.  .  .  .  .  .  .  .