Therapeutic Goods Act 1989

The regulations may make provision for and in relation to empowering the Secretary to make biologicals (priority applicant) determinations.

A biologicals (priority applicant) determination is a determination that, for the purposes of this Act, a specified person is a priority applicant in relation to any section 32DD application that may be made by the person for the inclusion in the Register of a biological specified in the determination.

The regulations may make provision for and in relation to the following matters:

applications for biologicals (priority applicant) determinations;

the approval by the Secretary of a form for such an application;

information that must accompany such an application;

the application fee for such an application;

empowering the Secretary to give the applicant a written notice requiring the applicant to give to the Secretary specified information or documents in connection with the application within a specified period (which must be at least 10 working days after the notice is given to the applicant).

The regulations may make provision for and in relation to the following matters:

empowering the Secretary to revoke a biologicals (priority applicant) determination;

the consequences of the revocation of a biologicals (priority applicant) determination.

Subsections (3) and (4) do not limit subsection (1).

A period prescribed under paragraph 63(2)(daa) for the evaluation of a biological covered by a section 32DD application for which the applicant is a priority applicant may be shorter than the period prescribed under that paragraph for the evaluation of a biological covered by a section 32DD application for which the applicant is not a priority applicant.

The regulations may provide that, if:

a person is a priority applicant in relation to a section 32DD application made by the person; and

a decision is made on the application;

The express references in this section to the Secretary do not, by implication, prevent the regulations from empowering the Secretary to delegate any or all of the Secretary’s functions or powers under regulations made for the purposes of this section.

If a biologicals (priority applicant) determination is in force under the regulations, the determination may be published on the Department’s website.

A biologicals (priority applicant) determination made under the regulations is not a legislative instrument.

Subsection 33(3AB) of the Acts Interpretation Act 1901 does not apply to the specification of a person in a biologicals (priority applicant) determination.

Subsection 33(3AB) of the Acts Interpretation Act 1901 deals with specification by class.