Therapeutic Goods Act 1989

The Secretary may, in writing, authorise a specified medical practitioner to supply a specified biological, for use in the treatment of humans, to the class or classes of recipients specified in the authority.

Section 32CN contains criminal offences relating to the giving an authority to a medical practitioner.

An application for an authority under subsection (1) must be in a form (if any) approved, in writing, by the Secretary.

The Secretary may give an authority under subsection (1) subject to any conditions that are specified in the authority.

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

The Secretary may impose conditions (or further conditions) on an authority given to a person under subsection (1) by giving to the person written notice of the conditions (or further conditions).

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

An authority under subsection (1) may only be given to a medical practitioner:

who is included in a class of medical practitioners prescribed by the regulations for the purposes of this paragraph; and

who has the approval of an ethics committee to supply the specified biological.

An authority under subsection (1) may only be given in relation to a class or classes of recipients prescribed by the regulations for the purposes of this subsection.

The regulations may prescribe the circumstances in which a biological may be supplied under an authority under subsection (1).

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

The Minister may, by legislative instrument, make rules authorising any health practitioner who is included in a specified class of health practitioners to supply a specified biological, for use in the treatment of humans, to the class or classes of recipients specified in those rules, so long as:

the biological is supplied in the circumstances specified in those rules; and

the conditions (if any) specified in those rules are satisfied.

In making rules under subsection (7A), the Minister must comply with:

such requirements (if any) as are prescribed by the regulations; and

such restrictions (if any) as are prescribed by the regulations; and

such limitations (if any) as are prescribed by the regulations.

If:

a person is authorised, by subsection (7A) rules, to supply a biological; and

the person supplies the biological in accordance with those rules;

notify the supply to the Secretary; and

do so within 28 days after the supply.

A notification under subsection (7C) must:

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

contain such information as is prescribed by the regulations.

An approval of a form may require or permit 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.

A person commits an offence if:

the person is subject to a requirement under subsection (7C); and

the person omits to do an act; and

the omission breaches the requirement.

An offence against subsection (7F) is an offence of strict liability.

For strict liability, see section 6.1 of the Criminal Code.

Subsection (7F) does not apply in relation to a person and a requirement to notify a supply of a biological if a health practitioner, on behalf of the person, does the following:

notifies the supply to the Secretary within 28 days after the supply;

makes the notification in accordance with the requirements referred to in subsection (7D).

A defendant bears an evidential burden in relation to the matter in subsection (7GA): see subsection 13.3(3) of the Criminal Code.

In recommending to the Governor‑General that regulations should be made for the purposes of paragraph (7D)(b), the Minister must have regard to the principle that information should only be prescribed for the purposes of that paragraph if the information is reasonably required for the responsible scrutiny by the Secretary of the operation of the scheme embodied in subsection (7A).