Therapeutic Goods Act 1989

The Secretary may, by notice in writing, grant an approval to a person for one or more of the following:

the importation into Australia of a specified biological;

the exportation from Australia of a specified biological;

the supply in Australia of a specified biological;

for use in the treatment of another person; or

for use solely for experimental purposes in humans.

For variation of an approval for use of the kind referred to in paragraph (1)(e), see subsection (9A).

An approval for use of the kind referred to in paragraph (1)(d) must not be granted to a person unless the person is a health practitioner.

Subsection (1) does not apply if the biological is included in the Register, the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2).

An application for an approval for use of the kind referred to in paragraph (1)(d) must:

be made to the Secretary; and

be in a form (if any) approved, in writing, by the Secretary; and

be accompanied by such information relating to the biological the subject of the application as is required by the Secretary.

An application for an approval for use of the kind referred to in paragraph (1)(e) must:

be made to the Secretary; and

be in a form (if any) approved, in writing, by the Secretary; and

be accompanied by such information relating to the biological the subject of the application as is required by the Secretary; and

be accompanied by the prescribed evaluation fee.

If an application for an approval is made, the Secretary must:

after having considered the application; and

in the case of an application for an approval for use of the kind referred to in paragraph (1)(e)—after having evaluated the information submitted with the application;

The Secretary may grant an approval under subsection (1) subject to any conditions that are specified in the notice of approval.

There are criminal offences and a civil penalty related to the breach of a condition of an approval: see sections 32CP and 32CQ.

Those conditions may include a condition relating to the charges that may be made for the biological to which the approval relates. This subsection does not limit subsection (6).

An approval under subsection (1) for use of the kind referred to in paragraph (1)(e) is subject to the conditions (if any) specified in the regulations. Those conditions (if any) are in addition to any conditions imposed under subsection (6).

There are criminal offences and a civil penalty related to the breach of a condition of an approval: see sections 32CP and 32CQ.

If:

the Secretary grants an approval to a person under subsection (1) for use of the kind referred to in paragraph (1)(e); and

the person requests the Secretary to do either or both of the following:

vary the biological specified in the approval;

vary the conditions imposed under subsection (6) on the approval; and

the request is in a form (if any) approved, in writing, by the Secretary; and

the request is accompanied by such information relating to the biological as is required by the Secretary; and

the request is accompanied by the fee prescribed by the regulations;

The Secretary must notify the person making the request under subsection (9A) of:

the Secretary’s decision on the request; and

for a decision to vary the approval in a way that is different than the variation requested or a decision to refuse to vary the approval—the reasons for the decision.

A variation under subsection (9A) takes effect at the time the Secretary notifies the person under subsection (9B) of the variation.

An approval under subsection (1) is not a legislative instrument.