Therapeutic Goods (Emergency) Exemption 2004 (No. 3) (Cth)

ATTACHMENT A

Therapeutic Goods (Emergency) Exemption 2004 (No3)

I, PATRICIA MARY WORTH, Parliamentary Secretary to the Minister for Health and Ageing,

(a) acting under subsection 18A(1), and paragraph 18A(2)(a), of the Therapeutic Goods Act 1989; and

(b) being satisfied that, in the national interest, this Exemption should be made so that certain therapeutic goods may be stockpiled as quickly as possible to deal with a potential threat to public health that may be caused by a possible future emergency;

exempt the therapeutic goods mentioned in item 1 of this instrument from the operation of Division 2 of Part 3-2 of the Therapeutic Goods Act 1989, subject to the conditions mentioned in item 3.

Dated               10^th of August                    2004

P.M. Worth

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

The following goods are exempted:

(a)        200 bottles each containing 30 capsules of insoluble Prussian Blue, each  capsule containing 0.5 g of insoluble ferric hexacyanoferrate (II) for the treatment of internal contamination with radioactive caesium and radioactive thallium to increase their rates of elimination.

(b)        200 5 ml ampoules of Ca-DTPA (pentetate calcium trisodium, also known as calcium trisodium pentetate) for injection, each containing 1 g in 5 ml of sterile aqueous solution for the initial treatment of patients with internal contamination with plutonium, americium or curium.

(c)        2000 5 ml ampoules of Zn-DTPA (pentetate zinc trisodium) for injection each containing 1 g in 5 ml of sterile aqueous solution for the continuation of treatment of patients with internal contamination with plutonium, americium or curium.

The goods at (a), (b) and (c) above are manufactured by:

Heyl Chemisch-pharmazeutische Fabrik GmBH & Co. KG

Goerzalle 253

D-141167 Berlin (Zehlendorf), Germany.

1. Period of exemption

This Exemption for the above three products ends on 31 August 2012.

Note 1            This Exemption takes effect on the day it is made (see subsection 18A(3) of the Act).

Note 2.           Subsections 18A(4) and (5) of the Act make further provision for cessation of an exemption.

1. Conditions

This Exemption is subject to the following conditions:

(a)the goods must be purchased by the Commonwealth for the prevention of radiological contamination in humans;

(b)the goods are to be imported by the Australian Government Department of Health and Ageing;

(c)the goods must be imported from the manufacturer named in Clause 1 above;

(d)the goods are to be stored under the direction of the Secretary of the Department of Health and Ageing (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);

(e)the goods are supplied from the stockpile, and used, only in a manner approved, in writing, by the Secretary of the Australian Government Department of Health and Ageing;

(f)records in relation to the distribution and supply of the goods must be 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 of the Australian Government Department of Health and Ageing; and

(iii)for not less than 10 years;

(g)the goods must be disposed of in accordance with the Therapeutic Goods Regulations 1990;

(h)a person who is in control or possession of unused goods when this exemption ceases to have effect is not entitled to compensation if the person is required to dispose of the unused goods in accordance with this instrument and the Therapeutic Goods Regulations 1990.

Note State is defined in subsection 3(1) of the Act to include the Australian Capital Territory and the Northern Territory.