Applications for provisional determination
22C Applications for provisional determination
A person may make an application to the Secretary for a provisional determination relating to a medicine of a kind prescribed by the regulations for the purposes of this subsection.
If the Secretary makes the determination, the person applies under section 23 for registration of the medicine and that application passes preliminary assessment, then a different kind of evaluation of the medicine will occur under section 25.
An application under subsection (1) must:
be made in accordance with a form approved, in writing, by the Secretary; and
be accompanied by the prescribed application fee; and
contain the information that the form requires, and any further information, statement or document the Secretary requires, whether in the form or otherwise; and
satisfy any other requirement prescribed by the regulations for the purposes of this paragraph.
An approval of a form may require or permit an application or information to be given in accordance with specified software requirements:
on a specified kind of data processing device; or
by way of a specified kind of electronic transmission.
This provision refers to the regulations (prescribed by the regulations
). Made under this Act:
- Therapeutic Goods (Medical Devices) Regulations 2002 · under s 63
- Therapeutic Goods Regulations 1990 · under s 63
5 more instruments made under this Act are listed on the Act’s overview.
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