Therapeutic Goods Act 1989

A person may apply to the Secretary for a recommendation that the Minister vary a determination under section 26BF.

An application under subsection (1) must:

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

set out the recommendation sought; and

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

be accompanied by the prescribed application fee (if any).

A person cannot make an application under subsection (1) for a recommendation the effect of which would be for the determination to cover any of the following:

an indication specified in a determination under section 26BG;

an indication that is or contains a restricted representation (within the meaning of Part 5‑1);

unless subsection (4) applies—an indication that is or contains a prohibited representation (within the meaning of Part 5‑1);

unless subsection (5) applies—an indication that refers to preventing, curing or alleviating a disease, ailment, defect or injury.

For the purposes of paragraph (3)(c), this subsection applies if:

the indication is a therapeutic use that relates to sun protection; and

the prohibited representation relates to the prevention of skin cancer; and

the use of the prohibited representation is permitted under section 42DK.

For the purposes of paragraph (3)(d), this subsection applies if the indication refers to:

the prevention of a dietary deficiency; or

the prevention of skin cancer or sun damage.

The Secretary may, by written notice given to a person who has made an application under subsection (1), require the person to:

give the Secretary such further information in connection with the application as is specified in the notice; and

do so within such reasonable time as is specified in the notice.

An application made under subsection (1) lapses if:

the application contains information that is inaccurate or misleading in a material particular; or

information given to the Secretary by, or on behalf of, the applicant in connection with the application is inaccurate or misleading in a material particular.

If:

an application is made under subsection (1); and

any applicable prescribed application fee has been paid; and

if further information is required to be given under subsection (6) within a specified time—the information is given within that time;

In deciding whether to make the recommendation, the Secretary may have regard to whether the indication to which the application relates is a therapeutic use that relates to one or more of the following:

maintaining health;

enhancing health;

preventing a dietary deficiency;

a disease, ailment, defect or injury, other than a serious form of the disease, ailment, defect or injury;

sun protection.

If the Secretary refuses to make the recommendation, the Secretary must:

notify the applicant in writing of his or her decision; and

state in the notice the reasons for the decision.

If the Secretary makes a recommendation under subsection (8), the Minister must:

by legislative instrument, vary the determination under subsection 26BF(1); or

refuse to vary the determination.

In deciding whether to vary a determination under subsection 26BF(1) to include an indication not already covered by the determination, the Minister may have regard to:

the recommendation made under subsection (8) of this section; and

whether the indication is a therapeutic use that relates to one or more of the matters in paragraphs (9)(a) to (e) of this section.

Subsection (12) does not limit the matters to which the Minister may have regard in deciding whether to vary the determination.

An approval of a form mentioned in paragraph (2)(a), or a notice mentioned in subsection (6), 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.