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Commonwealth legislation
This Act has been repealed and is no longer in force. It is retained for historical reference.
This law temporarily exempts two emergency autoinjectors (Combopen and Atropen) from usual therapeutic goods registration from 1 Jan 2003 to 31 Dec 2008, allowing them to be held in the national medical stockpile for nerve‑agent/chemical incidents.
It places custody, storage and supply under the Commonwealth Secretary for Health with written approval required, obliges State/Territory Chief Health Officers to keep 10‑year distribution records, requires regulated disposal under existing regulations, and bars compensation for disposal — preserving emergency readiness under strict government control.
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Direct links to the current provisions in Therapeutic Goods (Emergency) Exemption 2002 (No. 3).
Combopen Autoinjectors and Atropen Autoinjectors that, on 31 December 2002, are exempt under subsection 18 (1) of the Act.
2 Period of exemption
This Exemption takes effect on 1 January 2003 and ends on 31 December 2008.
Note Subsections 18A (4) and (5) of the Act make further provision for cessation of an exemption.
The following conditions apply:
(a) the goods are stored under the direction of the Secretary (which may include directions as to the temperature at which the goods must be stored, the security of the goods, and the premises at which the goods must be stored);
(b) the goods are supplied from the stockpile, and used, in a manner approved, in writing, by the Secretary;
(c) records in relation to the distribution and supply of the goods are kept:
(i) for goods supplied in a particular State — by the Chief Health Officer (however described) for the State; and
(ii) in a manner directed by the Secretary; and
(iii) for not less than 10 years;
(d) the goods are disposed of in accordance with the Therapeutic Goods Regulations 1990;
(e) the goods are imported, supplied and used on the understanding that a direction by the Secretary, that the goods be disposed of in accordance with the Therapeutic Goods Regulations 1990, creates no entitlement in any person to compensation in relation to the disposal.
Note State is defined in subsection 3 (1) of the Act to include the Australian Capital Territory and the Northern Territory.
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
Combopen Autoinjectors and Atropen Autoinjectors that, on 31 December 2002, are exempt under subsection 18 (1) of the Act.
2 Period of exemption
This Exemption takes effect on 1 January 2003 and ends on 31 December 2008.
Note Subsections 18A (4) and (5) of the Act make further provision for cessation of an exemption.
The following conditions apply:
(a) the goods are stored under the direction of the Secretary (which may include directions as to the temperature at which the goods must be stored, the security of the goods, and the premises at which the goods must be stored);
(b) the goods are supplied from the stockpile, and used, in a manner approved, in writing, by the Secretary;
(c) records in relation to the distribution and supply of the goods are kept:
(i) for goods supplied in a particular State — by the Chief Health Officer (however described) for the State; and
(ii) in a manner directed by the Secretary; and
(iii) for not less than 10 years;
(d) the goods are disposed of in accordance with the Therapeutic Goods Regulations 1990;
(e) the goods are imported, supplied and used on the understanding that a direction by the Secretary, that the goods be disposed of in accordance with the Therapeutic Goods Regulations 1990, creates no entitlement in any person to compensation in relation to the disposal.
Note State is defined in subsection 3 (1) of the Act to include the Australian Capital Territory and the Northern Territory.