Document ID: chunk:federal_register_of_legislation:C2018A00007:clause:1_12:p1
Version: federal_register_of_legislation:C2018A00007
Segment Type: clause
Provision Reference: sch 1 cl 12 (pt 1/2)
Character Range: 16151–19012

12  At the end of section 29
Add:

Provisionally registered medicine
 (2) If:
 (a) a person makes an application for provisional registration of a medicine; and
 (b) in relation to that application, the Secretary decides under subsection 25(3) to register the medicine; and
 (c) the medicine is included in the Register in relation to the person;
then:
 (d) the medicine is provisionally registered; and
 (e) the medicine remains included in the Register for the provisional registration period, unless the medicine's registration is cancelled under this Part earlier.
Note: The medicine is taken not to be included in the Register while its registration is suspended: see section 29G.
 (3) Subject to this section, the provisional registration period is the 2 years starting on the day the registration commences.
Note: Subsection 25AB(6) provides that registration commences on the day specified in the certificate of registration.

Extension of provisional registration upon application
 (4) The person in relation to whom the medicine is provisionally registered may make an application to the Secretary to extend the provisional registration period.
 (5) The application must:
 (a) be in a form approved, in writing, by the Secretary; and
 (b) contain the information that the form requires, and any further information, statement or document the Secretary requires, whether in the form or otherwise; and
 (c) be made at least 6 months before the provisional registration of the medicine is due to end; and
 (d) be accompanied by the prescribed application fee.
 (6) On receiving the application, the Secretary must decide to grant, or to refuse to grant, an extension of the provisional registration period. In making that decision, the Secretary must have regard to:
 (a) whether the Secretary is satisfied with the applicant's plan to submit comprehensive clinical data on the safety and efficacy of the medicine before the end of the 6 years starting on the day the provisional registration commenced; and
 (b) such other matters (if any) as the Secretary considers relevant.
 (7) As soon as practicable after making the decision, the Secretary must:
 (a) give the applicant written notice of the decision; and
 (b) if the Secretary decides to extend the provisional registration period—specify in the notice the period of the extension (which must not exceed 2 years and may be less than the period sought by the applicant); and
 (c) if the Secretary refuses to extend the provisional registration period—set out the reasons for the refusal in the notice.
Note: At the time of granting an extension, the Secretary may impose new conditions on the provisional registration or vary the existing conditions: see subsection 28(3).
 (8) No more than 2 extensions may be granted on applications under subsection (4).
Note: Under subsection (9) the Secretary