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THERAPEUTIC GOODS ACT 1989 - SECT 32BF

Civil penalties for importing, exporting, manufacturing or supplying a biological

Importing a biological for use in humans

             (1)  A person contravenes this subsection if:

                     (a)  the person imports into Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  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;

                             (v)  the biological is the subject of an approval under subsection 32CO(1), (1A) or (2) that is held by the person.

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

Exporting a biological for use in humans

             (2)  A person contravenes this subsection if:

                     (a)  the person exports from Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  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:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

Manufacturing a biological for use in humans

             (3)  A person contravenes this subsection if:

                     (a)  the person manufactures in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB.

Maximum civil penalty:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

Supplying a biological for use in humans

             (4)  A person contravenes this subsection if:

                     (a)  the person supplies in Australia a biological for use in humans; and

                     (b)  none of the following subparagraphs applies:

                              (i)  the biological is included in the Register in relation to the person;

                             (ii)  the person is exempt under subsection 32CA(1) in relation to the biological or the biological is exempt under subsection 32CA(2);

                            (iii)  the biological is exempt under section 32CB;

                            (iv)  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;

                             (v)  the biological is the subject of an authority under subsection 32CM(1) or (7A) that covers the supply of the biological by the person;

                            (vi)  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:

                     (a)  for an individual--5,000 penalty units; and

                     (b)  for a body corporate--50,000 penalty units.

Exception if person was not the sponsor of the biological

             (5)  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

             (6)  A person contravenes this subsection if:

                     (a)  a biological is included in the Register in relation to the person; and

                     (b)  the biological is of a kind prescribed by the regulations for the purposes of this paragraph; and

                     (c)  the person supplies the biological in Australia; and

                     (d)  the biological number of the biological is not set out on the label of the biological in the prescribed manner.

Maximum civil penalty:

                     (a)  for an individual--200 penalty units; and

                     (b)  for a body corporate--2,000 penalty units.



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