THERAPEUTIC GOODS ACT 1989 - SECT 18A Exemption because of emergency
THERAPEUTIC GOODS ACT 1989 - SECT 18A
Exemption because of emergency(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.
(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;
(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;
(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 .
(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 class of persons to whom goods may be supplied for use and the circumstances under which a stockpile of goods may be supplied for use);
(f) the storage and security of those goods;
(g) the keeping and disclosure of, and access to, records about those goods;
(h) the disposal of those goods;
(i) the manner in which any of those goods are to be dealt with if a condition of the exemption is breached;
(j) any other matters that the Minister thinks appropriate.
Whether or not goods are exempt under this section is not affected by whether or not there is a breach of a condition of an exemption under this section in relation to those goods.
Note 1: A person may commit an offence by breaching a condition of an exemption under this section, see subsections 20(2A) and (2C), 22(7AB) and (7AD), and 30H(1) and (3).
Note 2: A person may also contravene a civil penalty provision, see section 22AA.
(8) The Minister may revoke or vary the conditions (including by imposing new conditions) after the exemption is made. The revocation or variation must be made in writing.
(9) A revocation or variation under subsection (8) 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) must not be earlier than 28 days after the day on which the revocation or variation is made.
Exemption not a legislative instrument
(9A) An exemption under subsection (1) is not a legislative instrument.
Informing persons of exemption etc.
(9B) If the Minister makes an exemption under subsection (1), the Minister must take reasonable steps to give a copy of the following to each person covered by paragraph (7)(d):
(b) any revocation or variation of the exemption under this section.
(10) The Secretary must cause a document setting out particulars of:
(a) an exemption covered by paragraph (2)(b) or subparagraph (2A)(b)(ii); and
(b) a revocation or variation under this section of an exemption covered by paragraph (2)(b) or subparagraph (2A)(b)(ii);
to be published in the Gazette within 5 working days after the day on which the Minister makes the exemption, revocation or variation. However, an exemption, or a revocation or variation, is not invalid merely because of a failure to comply with this subsection.
(11) The Minister must cause a document setting out particulars of:
(a) an exemption covered by paragraph (2)(b) or subparagraph (2A)(b)(ii); and
(b) a revocation or variation under this section of an exemption covered by paragraph (2)(b) or subparagraph (2A)(b)(ii);
to be tabled before each House of the Parliament within 5 sitting days of that House after the day on which the Minister makes the exemption, revocation or variation. However, an exemption, or a revocation or variation, is not invalid merely because of a failure to comply with this subsection.
Note: There are other requirements in other parts of this Act about goods exempt under this section:
(a) sections 20, 22 and 22AA (breach of a condition of the exemption);
(b) sections 30F and 30FA (goods not conforming to standards etc.);
(c) section 30G (disposal of unused goods);
(d) section 30H (record keeping);
(e) section 31AA (providing information to the Secretary);
(f) sections 35, 35A, 39 and 41 (manufacturing goods that are exempt under this section);
(g) section 46A (search of premises).