Therapeutic Goods Act 1989

A provisional determination under section 22D relating to a medicine:

comes into force on the day on which the Secretary gives the person notice under subsection 22D(4); and

subject to this section and section 22F, remains in force for the initial period.

For revocation of the determination, see section 22F.

The initial period is 6 months or another period prescribed by the regulations for the purposes of this subsection.

The person may make an application to the Secretary to extend the initial period.

The application must:

be in a form approved, in writing, by the Secretary; and

be made at least 28 days before the determination would otherwise cease to be in force; and

be accompanied by the prescribed application fee.

On receiving the application, the Secretary must decide to extend, or to refuse to extend, the initial period.

The Secretary may extend the initial period by 6 months, or another period prescribed by the regulations for the purposes of this subsection, if the Secretary:

is still satisfied that the criteria prescribed by the regulations for the purposes of subsection 22D(2) are met in relation to the medicine; and

is satisfied that, if the Secretary were to make the extension, the person would make an application under section 23 for provisional registration of the medicine before the end of the extended period.

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 extend the initial period—set out the reasons for the refusal in the notice.

Only one extension may be given.

If the person to whom the provisional determination relates makes an application under section 23 for provisional registration of the medicine before the end of the initial period (or that period as extended), the determination remains in force until:

the person withdraws the application; or

the application lapses in accordance with subsection 24(2); or

the person gives the Secretary written notice under subsection 24E(2) that the person wishes to treat the application as having been refused; or

the application is finally determined.

For the purposes of paragraph (9)(d), an application is finally determined when the application, and any applications for review or appeals arising out of it, have been finally determined or otherwise disposed of.