Therapeutic Goods Act 1989

A person may make an application to the Secretary for a recommendation by the Secretary that the Minister vary a section 26BB determination.

If such an application is made, the Secretary must carry out an assessment of whether the requirements set out in subsection (3) have been met in relation to the application.

The requirements are as follows:

the application must be made in accordance with a form approved, in writing, by the Secretary;

the application must set out the recommendation sought;

the prescribed application fee must be paid;

the application must be delivered to an office of the Department specified in the form;

the application must be accompanied by information that is:

of a kind determined under subsection (8); and

in a form determined under subsection (9).

An application passes preliminary assessment if the Secretary:

has carried out an assessment, under subsection (2), in relation to the application; and

is satisfied that the requirements set out in subsection (3) have been met in relation to the application.

If the application has passed preliminary assessment, the Secretary must give a written notice to the applicant stating that the application has passed preliminary assessment.

If the application has not passed preliminary assessment, the Secretary must, by written notice given to the applicant, refuse the application.

An approval of a form mentioned in paragraph (3)(a) 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.

The Secretary may, by legislative instrument, determine a kind of information for the purposes of subparagraph (3)(e)(i).

The Secretary may, by legislative instrument, determine a form of information for the purposes of subparagraph (3)(e)(ii).