Commonwealth Consolidated Acts

THERAPEUTIC GOODS ACT 1989 - SECT 19A

             (1)  The Secretary may, by notice in writing, grant an approval to a person for the importation into Australia, or the supply in Australia, of specified therapeutic goods if the Secretary is satisfied that:

                     (a)  registered goods that could act as a substitute for the goods are unavailable or are in short supply; and

                     (b)  either:

                              (i)  the goods that are the subject of the application are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); or

                             (ii)  an application that complies with section 23 has been made under that section for registration of the goods; and

                     (c)  the goods are of a kind:

                              (i)  included in Schedule 10 of the Therapeutic Goods Regulations; or

                             (ii)  specified by the Secretary in a determination under subsection (4); and

                     (d)  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 the importation into Australia, or the supply in Australia, of specified therapeutic goods if the Secretary is satisfied that:

                     (a)  registered goods that could act as a substitute for the goods do not exist; and

                     (b)  an application that complies with section 23 has been made under that section for registration of the goods; and

                     (c)  the goods are of a kind:

                              (i)  included in Schedule 10 of the Therapeutic Goods Regulations; or

                             (ii)  specified by the Secretary in a determination under subsection (4); and

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

             (3)  The Secretary may, for the purposes of subparagraph (1)(b)(i), make written determinations specifying the foreign countries in which registration or approval for general marketing of the goods is a prerequisite for approval by the Secretary under this section.

             (4)  The Secretary may make written determinations specifying the kinds of goods that can be the subject of an approval under this section.

             (5)  Determinations under subsections (3) and (4) are legislative instruments.

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

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

             (8)  The approval lapses if:

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

                     (b)  a decision has been made under section 25 in relation to the goods.

             (9)  The approval lapses if:

                     (a)  the Secretary is satisfied that paragraph (1)(a), (b), (c) or (d), or paragraph (2)(a), (b), (c) or (d), as the case requires, no longer applies in relation to the goods, 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.

           (10)  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 goods before the lapsing of the first‑mentioned approval. The other approval may be expressed to take effect on the expiry of that period.