Document ID: chunk:federal_register_of_legislation:C2004A00960:clause:1_18a:p1
Version: federal_register_of_legislation:C2004A00960
Segment Type: clause
Provision Reference: sch 1 cl 18A (pt 1/3)
Character Range: 1110–3768

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.

 (2) The Minister may exempt goods under subsection (1) only if the Minister is satisfied 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.

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 day specified by the Minister in the revocation or variation.
The day specified under paragraph (b) of this subsection must not be earlier than 28 days after the day on which the revocation or variation is made.

Note: The revocation or variation must be made in writing, see subsection 33(3) of the Acts Interpretation Act 1901.

Conditions for the exemption

 (7) The exemption is subject to conditions specified in the exemption about any of the following:
 (a) the period for which the exemption is to have effect;
 (b) the quantity of goods that are exempt;
 (c) the source of those goods;
 (d) the persons or class of persons who may import, manufacture, supply or export those goods;
 (e) the supply of those goods (including the persons or