Provisional determinations
22D Provisional determinations
If a person makes an application, in accordance with subsection 22C(2), for a provisional determination relating to a medicine, the Secretary must decide to make, or to refuse to make, the determination.
Criteria
The Secretary may make the determination if the Secretary is satisfied that the criteria prescribed by the regulations for the purposes of this subsection are met in relation to the medicine.
Content of determination
The determination must specify:
the person to whom the determination relates; and
the medicine to which the determination relates; and
the indication of the medicine to which the determination relates; and
each active ingredient of the medicine to which the determination relates.
The determination may specify any other matters that the Secretary considers appropriate.
Notice of decision
As soon as practicable after making the decision, the Secretary must:
give the person written notice of the decision; and
if the Secretary refuses to make the determination—set out the reasons for the refusal in the notice.
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.
This Act’s bill:Second reading speech
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