Therapeutic Goods Act 1989

Subject to this section, if goods are included in the Register in relation to a person, the goods remain so included until their registration or listing is cancelled under this Part.

The goods are taken not to be included in the Register while their registration or listing is suspended: see section 29G.

If:

a person makes an application for provisional registration of a medicine; and

in relation to that application, the Secretary decides under subsection 25(3) to register the medicine; and

the medicine is included in the Register in relation to the person;

the medicine is provisionally registered; and

the medicine remains included in the Register for the provisional registration period, unless the medicine’s registration is cancelled under this Part earlier.

The medicine is taken not to be included in the Register while its registration is suspended: see section 29G.

Subject to this section, the provisional registration period, for a medicine that is provisionally registered because of an application that, under subsection 23AA(1), is taken to be an application for provisional registration of the medicine, is the period of 2 years starting on the day the registration commences.

Subsection 25AB(6) provides that registration commences on the day specified in the certificate of registration.

Subject to this section, the provisional registration period, for a medicine (the new medicine) that is provisionally registered because of an application that, under subsection 23AA(2), is taken to be an application for provisional registration of the new medicine, is as follows:

if, in relation to the new medicine, the day (the start day) referred to in subsection 25AB(6) occurs in the period (the original period) referred to in subsection (3) of this section in relation to the original medicine concerned—the period starting on the start day and ending at the end of the original period;

if, in relation to the new medicine, the start day occurs in a period of extension of the original period that is granted under subsection (6)—the period starting on the start day and ending at the end of that extension period.

Subsection 25AB(6) provides that registration commences on the day specified in the certificate of registration.

The person in relation to whom the medicine is provisionally registered may make an application to the Secretary to extend the provisional registration period.

The application must:

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

be made:

if the medicine is provisionally registered because of an application that, under subsection 23AA(1), was taken to be an application for provisional registration of the medicine—at least 6 months before the provisional registration of the medicine is due to end; or

if the medicine is provisionally registered because of an application that, under subsection 23AA(2), was taken to be an application for provisional registration of the medicine—at least 1 month before the provisional registration of the medicine is due to end; and

be accompanied by the prescribed application fee.

If:

a person makes an application under subsection (4) in accordance with this section; and

the medicine is provisionally registered because of an application that, under subsection 23AA(1), was taken to be an application for provisional registration of the medicine;

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

such other matters (if any) as the Secretary considers relevant.

If:

a person makes an application under subsection (4) in accordance with this section; and

the medicine is provisionally registered because of an application that, under subsection 23AA(2), was taken to be an application for provisional registration of the medicine;

As soon as practicable after making a decision under subsection (6) or (6A), the Secretary must:

give the applicant written notice of the decision; and

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

if the Secretary refuses to extend the provisional registration period—set out the reasons for the refusal in the notice.

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).

No more than 2 extensions may be granted in relation to a medicine on applications under subsection (4).

Under subsection (9) the Secretary may extend the provisional registration period on his or her own initiative.

The Secretary must not, under subsection (6A), extend the provisional registration period applicable under subsection (3A) for the new medicine so that period would end more than 6 years after the provisional registration for the original medicine concerned commenced.

If:

before the provisional registration period ends, the person in relation to whom the medicine is provisionally registered makes an application under section 23 for registration of the medicine; and

the application is for the medicine to be included in the part of the Register for goods known as registered goods;

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).

In ending or extending, under subsection (9), the provisional registration period:

the Secretary must have regard to any matters prescribed by the regulations for the purposes of this paragraph; and

the Secretary must ensure the provisional registration period continues while the Secretary is considering the application, unless the medicine’s registration is cancelled under this Part; and

the Secretary must not extend the provisional registration period so it would end more than 6 years after the provisional registration commenced, unless the extension is for the purposes of paragraph (b).