Document ID: chunk:federal_register_of_legislation:C2024C00632:section:19:p3
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 19 (pt 3/4)
Character Range: 139745–142496

the conditions (if any) specified in the authority.
 (5B) The Secretary may impose conditions (or further conditions) on an authority given to a person under subsection (5) by giving to the person written notice of the conditions (or further conditions).
 (6) An authority under subsection (5) may only be given:
 (a) to a medical practitioner included in a class of medical practitioners prescribed by the regulations for the purposes of this paragraph; and
 (aa) to a medical practitioner who has the approval of an ethics committee to supply the specified therapeutic goods or the specified class of such goods; and
 (b) in relation to a class or classes of recipients prescribed by the regulations for the purposes of this paragraph.
Paragraph (aa) does not apply in the circumstances (if any) prescribed by the regulations for the purposes of this subsection.
 (7) The regulations may prescribe the circumstances in which therapeutic goods may be supplied under an authority under subsection (5).
 (7A) 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 therapeutic goods for use in the treatment of humans; or
 (b) a specified class of such goods;
to the class or classes of recipients specified in those rules, so long as:
 (c) the goods are supplied in the circumstances specified in those rules; and
 (d) the conditions (if any) specified in those rules are satisfied.
 (7B) In making rules under subsection (7A), the Minister must comply with:
 (a) such requirements (if any) as are prescribed by the regulations; and
 (b) such restrictions (if any) as are prescribed by the regulations; and
 (c) such limitations (if any) as are prescribed by the regulations.
 (7C) If:
 (a) a person is authorised, by subsection (7A) rules, to supply therapeutic goods; and
 (b) the person supplies those goods in accordance with those rules;
the person must:
 (c) notify the supply to the Secretary; and
 (d) do so within 28 days after the supply.
 (7D) A notification under subsection (7C) must:
 (a) be in accordance with a form that is approved, in writing, by the Secretary; and
 (b) contain such information as is prescribed by the regulations.
 (7E) An approval of a form may require or permit information to be given in accordance with specified software requirements:
 (a) on a specified kind of data processing device; or
 (b) by way of a specified kind of electronic transmission.
 (7F) A person commits an offence if:
 (a) the person is subject to a requirement under subsection (7C); and
 (b) the person omits to do an act; and
 (c) the omission breaches the requirement.
Penalty: 10 penalty units.
 (7G) An offence