Document ID: chunk:federal_register_of_legislation:C2024C00632:section:18a:p1
Version: federal_register_of_legislation:C2024C00632
Segment Type: section
Provision Reference: s 18A (pt 1/3)
Character Range: 127910–130547

18A  Exemption because of emergency

Minister's power
 (1) The Minister may exempt from the operation of Division 2 of this Part:
 (a) specified therapeutic goods; or
 (b) therapeutic goods in a specified class.
The exemption must be made in writing.
 (1A) The Minister may exempt goods under subsection (1) only if the Minister is satisfied of the matter in subsection (2) or (2A).
 (2) The matter in this subsection is that in the national interest:
 (a) the exemption should be made so that the goods may be stockpiled as quickly as possible in order to create a preparedness to deal with a potential threat to public health that may be caused by a possible future emergency; or
 (b) the exemption should be made so that the goods can be made available urgently in Australia in order to deal with an actual threat to public health caused by an emergency that has occurred.
 (2A) The matter in this subsection is that:
 (a) a national emergency declaration is in force; and
 (b) either of the following apply:
 (i) the exemption should be made so that the goods may be stockpiled to deal with a potential threat to public health that may be caused by the emergency to which the national emergency declaration relates;
 (ii) the exemption should be made so that the goods can be made available urgently in Australia in order to deal with an actual threat to public health caused by the emergency to which the national emergency declaration relates; and
 (c) the Minister is satisfied that the exemption is in the national interest.

When the exemption has effect
 (3) The exemption takes effect:
 (a) on the day on which the exemption is made; or
 (b) on a later day that is specified in the exemption.
 (4) The exemption ceases to have effect:
 (a) at the end of the period specified by the Minister in the exemption as the period for which the exemption is to have effect; or
 (b) when the exemption is revoked;
whichever first occurs.
 (5) The exemption ceases to have effect in relation to particular therapeutic goods:
 (a) when those goods become registered or listed goods; or
 (b) when the Minister varies the exemption by removing those goods from the exemption;
whichever first occurs.
 (6) If the Minister revokes the exemption as mentioned in paragraph (4)(b), or varies the exemption as mentioned in paragraph (5)(b), the revocation or variation takes effect:
 (a) if the Minister states in the revocation or variation that the revocation or variation is necessary to prevent imminent risk of death, serious illness or serious injury—on the day on which the revocation or variation is made; or
 (b) in any other case—on the