Medicines, Poisons and Therapeutic Goods Act 2022
70Application for approval
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70 Application for approval
70 Application for approval
(1) A person may apply to the Health Secretary for an approval.
(2) An application must—
(a) be in an approved form, and
(b) include or be accompanied by information or evidence the Health Secretary reasonably requires to assess the application.
Note—
The Crimes Act 1900, Part 5A contains offences relating to the making of false or misleading applications or providing false or misleading information or documents. The offences have a maximum penalty of imprisonment for 2 years or a $22,000 fine, or both.
(3) The Health Secretary must give the applicant written notice of a decision to grant or refuse an approval within the prescribed period.
(4) If the Health Secretary fails to give notice within the prescribed period, the Health Secretary is taken to have refused the application.
Note—
Section 83 enables the Health Secretary to require an applicant to provide further information in relation to an application. The Health Secretary may refuse to deal with the application until the information is provided and may reject the application after 6 months.