Therapeutic Goods Act 1989

If an application is made under section 32DD for the inclusion of a biological in the Register, the Secretary must carry out an assessment of whether the requirements set out in subsection (2) of this section have been met in relation to the application.

The requirements are as follows:

the application must be made:

in accordance with the form approved, in writing, by the Secretary for that class of biological; or

in such other manner as is approved, in writing, by the Secretary for that class of biological;

the prescribed application fee for that class of biological must be paid;

the application must be delivered to an office of the Department specified by the Secretary;

the application must be accompanied by information that is:

of a kind determined under subsection (9) for that class of biological; and

in a form determined under subsection (10) for that class of biological;

if the Secretary so requires—the applicant must:

deliver to the Department a reasonable number of samples of the biological; and

do so in a manner approved, in writing, by the Secretary;

if there are one or more absolute prohibitions in force for the purposes of subsection 9K(1) or (3)—the application must be accompanied by a statement from the applicant certifying that:

if those prohibitions cover imports—any imports into Australia of the biological by, or on behalf of the applicant, will not contravene those prohibitions; and

if those prohibitions cover exports—any exports from Australia of the biological by, or on behalf of the applicant, will not contravene those prohibitions; and

if those prohibitions cover supplies—any supplies in Australia of the biological by, or on behalf of the applicant, will not contravene those prohibitions; and

if there are one or more prohibitions in force for the purposes of subsection 9K(1) or (3) that are subject to conditions—the application must be accompanied by a statement from the applicant certifying that:

if those prohibitions cover imports—any imports into Australia of the biological by, or on behalf of the applicant, will not contravene those conditions; and

if those prohibitions cover exports—any exports from Australia of the biological by, or on behalf of the applicant, will not contravene those conditions; and

if those prohibitions cover supplies—any supplies in Australia of the biological by, or on behalf of the applicant, will not contravene those conditions.

An application passes preliminary assessment if the Secretary:

has carried out an assessment, under subsection (1), in relation to the application; and

is satisfied that the requirements set out in subsection (2) 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.

Subsection (4) does not apply if the period within which the Secretary must, under section 32DE, evaluate the biological to which the application relates is prescribed by reference to the prescribed period within which the Secretary is required to consider an application under subsection 9D(3) to vary an entry in the Register.

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

For the purposes of paragraph (2)(a), the Secretary may approve different forms and manners for making applications for different classes of biologicals that are prescribed by the regulations for the purposes of section 32AA.

An approval of a form 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 the application of subparagraph (2)(d)(i) to a class of biological that is prescribed by the regulations for the purposes of section 32AA.

The Secretary may, by legislative instrument, determine a form of information for the purposes of the application of subparagraph (2)(d)(ii) to a class of biological that is prescribed by the regulations for the purposes of section 32AA.