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THERAPEUTIC GOODS ACT 1989 - SECT 32CO

Approvals where substitutes for biologicals are unavailable etc.

             (1)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified biological; or

                     (b)  the importation into Australia of a specified biological and the supply in Australia of that biological;

if the Secretary is satisfied that:

                     (c)  therapeutic goods included in the Register that could act as a substitute for the biological are unavailable or are in short supply; and

                     (d)  any of the following conditions is satisfied:

                              (i)  the biological that is the subject of the application for approval is registered or approved for general marketing in at least one foreign country specified by the Secretary under subsection (5);

                             (ii)  an application that complies with section 32DA has been made for inclusion of the biological in the Register;

                            (iii)  an application under section 32DD has been made for inclusion of the biological in the Register, and the application has passed preliminary assessment; and

                     (e)  the biological is of a kind specified by the Secretary in a determination under subsection (6); and

                      (f)  the approval is necessary in the interests of public health.

          (1A)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified biological; or

                     (b)  the importation into Australia of a specified biological and the supply in Australia of that biological;

if the Secretary is satisfied that:

                     (c)  therapeutic goods included in the Register that could act as a substitute for the biological are unavailable or are in short supply; and

                     (d)  either:

                              (i)  the biological that is the subject of the application for approval is not registered or approved for general marketing in any of the foreign countries specified by the Secretary under subsection (5); or

                             (ii)  the biological that is the subject of the application for approval is registered or approved for general marketing in at least one foreign country specified by the Secretary under subsection (5), but is not readily available for importation into, and supply in, Australia; and

                     (e)  the biological is registered or approved for general marketing in a foreign country; and

                      (f)  the manufacturing and quality control procedures used in the manufacture of the biological are acceptable; and

                     (g)  the biological is of a kind specified by the Secretary in a determination under subsection (6); and

                     (h)  the approval is necessary in the interests of public health.

             (2)  The Secretary may, by notice in writing, grant an approval to a person for:

                     (a)  the importation into Australia of a specified biological; or

                     (b)  the importation into Australia of a specified biological and the supply in Australia of that biological;

if the Secretary is satisfied that:

                     (c)  there are no therapeutic goods that are included in the Register that could act as a substitute for the biological; and

                     (d)  either:

                              (i)  an application that complies with section 32DA has been made for inclusion of the biological in the Register; or

                             (ii)  an application under section 32DD has been made for inclusion of the biological in the Register, and the application has passed preliminary assessment; and

                     (e)  the biological is of a kind specified by the Secretary in a determination under subsection (6); and

                      (f)  the approval is necessary in the interests of public health.

Application for approval

             (3)  An application for an approval must:

                     (a)  be made to the Secretary; and

                     (b)  be accompanied by such information relating to the biological as is required by the Secretary.

Secretary's decision

             (4)  If an application for an approval is made, the Secretary must, after having considered the application, notify the applicant of the decision on the application as soon as practicable after making the decision and, in the case of a decision not to grant the approval, of the reasons for the decision.

Determinations

             (5)  The Secretary may, by legislative instrument, make a determination specifying foreign countries for the purposes of subparagraph (1)(d)(i).

             (6)  The Secretary may, by legislative instrument, make a determination specifying the kinds of biologicals that can be the subject of an approval under this section.

Conditions

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

             (8)  A person commits an offence if:

                     (a)  the person does an act or omits to do an act; and

                     (b)  the act or omission results in the breach of a condition of an approval under subsection (1), (1A) or (2).

Penalty:  60 penalty units.

Period of approval

             (9)  The Secretary may grant an approval for such period as is specified in the notice of approval.

When approval lapses

           (10)  The approval lapses if:

                     (a)  the period specified in the notice of approval expires; or

                     (b)  a decision has been made on an application that has been made for inclusion of the biological in the Register.

           (11)  The approval lapses if:

                     (a)  the Secretary is satisfied that paragraph (1)(c), (d), (e) or (f), paragraph (1A)(c), (d), (e), (f), (g) or (h), or paragraph (2)(c), (d), (e) or (f), as the case requires, no longer applies in relation to the biological, or that a condition of the approval has been contravened; and

                     (b)  the Secretary has given to the person to whom the approval was granted a notice stating that the Secretary is so satisfied.

           (12)  The lapsing of the approval on the expiry of the period specified in the notice of approval does not prevent another approval being granted under this section in relation to the biological before that lapsing. The other approval may be expressed to take effect on the expiry of that period.

Approval not a legislative instrument

           (13)  An approval under subsection (1), (1A) or (2) is not a legislative instrument.



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