19AApprovals where unavailability etc. of therapeutic goods

#### 19A Approvals where unavailability etc. of therapeutic goods (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: (i) are unavailable or are in short supply; or (ii) may, in the reasonably foreseeable future, become unavailable or be 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 under section 23 has been made for registration of the goods and the application has passed preliminary assessment; and (c) the goods are of a kind: (i) included in Schedule 10 to the Therapeutic Goods Regulations 1990; or (ii) specified by the Secretary in a determination under subsection (4); and (d) 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 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: (i) are unavailable or are in short supply; or (ii) may, in the reasonably foreseeable future, become unavailable or be in short supply; and (b) either: (i) the goods that are the subject of the application are not registered or approved for general marketing in any of the foreign countries specified by the Secretary in a determination under subsection (3); or (ii) 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), but are not readily available for importation into, and supply in, Australia; and (c) the goods are registered or approved for general marketing in a foreign country; and (d) the manufacturing and quality control procedures used in the manufacture of the goods are acceptable; and (e) the goods are of a kind: (i) included in Schedule 10 to the Therapeutic Goods Regulations 1990; or (ii) specified by the Secretary in a determination under subsection (4); and (f) 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 under section 23 has been made for registration of the goods; and (ba) the application has passed preliminary assessment; and (c) the goods are of a kind: (i) included in Schedule 10 to the Therapeutic Goods Regulations 1990; or (ii) specified by the Secretary in a determination under subsection (4); and (d) the approval is necessary in the interests of public health. (2A) 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 (the subject goods) if the Secretary is satisfied: (a) that there are no registered goods that could act as a substitute for the subject goods; and (b) either: (i) that previously registered goods could act as a substitute for the subject goods; or (ii) that therapeutic goods whose registration is suspended under section 29D could act as a substitute for the subject goods; and (c) that the subject goods are registered or approved for general marketing in at least one foreign country specified by the Secretary in a determination under subsection (3); and (d) that the subject goods are of a kind included in Schedule 10 to the Therapeutic Goods Regulations 1990; and (e) that the approval is necessary in the interests of public health. (2B) 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 (the subject goods) if the Secretary is satisfied: (a) that there are no registered goods that could act as a substitute for the subject goods; and (b) either: (i) that previously registered goods could act as a substitute for the subject goods; or (ii) that therapeutic goods whose registration is suspended under section 29D could act as a substitute for the subject goods; and (c) that all of the following apply: (i) the subject goods are not registered or approved for general marketing in any of the foreign countries specified by the Secretary in a determination under subsection (3); (ii) the subject goods are registered or approved for general marketing in at least one foreign country that is not specified by the Secretary in a determination under subsection (3); (iii) the manufacturing and quality control procedures used in the manufacture of the subject goods are acceptable; and (d) that the subject goods are of a kind included in Schedule 10 to the Therapeutic Goods Regulations 1990; and (e) that the approval is necessary in the interests of public health. (3) The Secretary may make written determinations specifying foreign countries for the purposes of 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 subsection 25(3) in relation to the goods. (9) The approval lapses if: (a) the Secretary is satisfied that paragraph (1)(a), (b), (c) or (d), paragraph (1A)(a), (b), (c), (d), (e) or (f), paragraph (2)(a), (b), (ba), (c) or (d), paragraph (2A)(a), (b), (c), (d) or (e) or paragraph (2B)(a), (b), (c), (d) or (e), 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. (11) An approval under subsection (1), (1A), (2), (2A) or (2B) is not a legislative instrument.