Civil penalties for importing, exporting, manufacturing or supplying a biological
32BF Civil penalties for importing, exporting, manufacturing or supplying a biological
Importing a biological for use in humans
A person contravenes this subsection if:
the person imports into Australia a biological for use in humans; and
none of the following subparagraphs applies:
the biological is included in the Register in relation to the person;
the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);
the biological is exempt under section 32CB;
the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the importation into Australia of the biological;
the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person.
Maximum civil penalty:
for an individual—5,000 penalty units; and
for a body corporate—50,000 penalty units.
Exporting a biological for use in humans
A person contravenes this subsection if:
the person exports from Australia a biological for use in humans; and
none of the following subparagraphs applies:
the biological is included in the Register in relation to the person;
the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);
the biological is exempt under section 32CB;
the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the exportation from Australia of the biological.
Maximum civil penalty:
for an individual—5,000 penalty units; and
for a body corporate—50,000 penalty units.
Manufacturing a biological for use in humans
A person contravenes this subsection if:
the person manufactures in Australia a biological for use in humans; and
none of the following subparagraphs applies:
the biological is included in the Register in relation to the person;
the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);
the biological is exempt under section 32CB.
Maximum civil penalty:
for an individual—5,000 penalty units; and
for a body corporate—50,000 penalty units.
Supplying a biological for use in humans
A person contravenes this subsection if:
the person supplies in Australia a biological for use in humans; and
none of the following subparagraphs applies:
the biological is included in the Register in relation to the person;
the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);
the biological is exempt under section 32CB;
the biological is the subject of an approval under subsection 32CK(1) that is held by the person, being an approval covering the supply in Australia of the biological;
the biological is the subject of an authority under subsection 32CM(1) or (7A) that covers the supply of the biological by the person;
the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person, being an approval covering the supply in Australia of the biological.
Maximum civil penalty:
for an individual—5,000 penalty units; and
for a body corporate—50,000 penalty units.
Exception if person was not the sponsor of the biological
Subsection (1), (2), (3) or (4) does not apply if the person proves that he or she was not the sponsor of the biological at the time of the importation, exportation, manufacture or supply, as the case may be.
Civil penalty relating to the supply of biologicals included in the Register
A person contravenes this subsection if:
a biological is included in the Register in relation to the person; and
the biological is of a kind prescribed by the regulations for the purposes of this paragraph; and
the person supplies the biological in Australia; and
the person does not have the consent in writing of the Secretary; and
the biological number of the biological is not set out on the label of the biological in the prescribed manner.
Maximum civil penalty:
for an individual—200 penalty units; and
for a body corporate—2,000 penalty units.
Application of the Customs Act 1901
If:
the importation or exportation of a biological contravenes subsection (1) or (2); and
the Secretary notifies the Comptroller‑General of Customs in writing that the Secretary wishes the Customs Act 1901 to apply to that importation or exportation;
the Customs Act 1901 has effect as if the biological included in that importation or exportation were goods described as forfeited to the Crown under section 229 of that Act because they were:
prohibited imports within the meaning of that Act; or
prohibited exports within the meaning of that Act;
as the case requires.
Decisions on whether to give consent
The Secretary must, as soon as practicable after making a decision to give a consent mentioned in subsection (6), cause particulars of the decision to be published on the Department’s website.
The Secretary must, within 28 days after making a decision to refuse to give a consent mentioned in subsection (6), notify the applicant in writing of the decision and of the reasons for the decision.
The Secretary is not required to consider giving an applicant a consent mentioned in subsection (6) unless the applicant has paid the fee (if any) that is prescribed by the regulations for the processing of the applicant’s application for such a consent.
This provision refers to the regulations (prescribed by the regulations
, prescribed manner
). Made under this Act:
- Therapeutic Goods (Medical Devices) Regulations 2002 · under s 63
- Therapeutic Goods Regulations 1990 · under s 63
5 more instruments made under this Act are listed on the Act’s overview.
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