Therapeutic Goods (Emergency) Exemption 2007 (No. 2) (Cth)

Therapeutic Goods (Emergency) Exemption 2007 (No 2)

I, BRETT MASON, 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 (the Act); 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 in order to create a preparedness 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 document 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 this   25^th  day of   July  2007

Brett Mason

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

The following goods are exempted:

(i) goods to be purchased by the Commonwealth from Heyl Chemisch-pharmazeutische Fabrik GmBH & Co. KG, Goerzalle 253 D-141167 Berlin (Zehlendorf), Germany and consisting of:

(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 1g in 5ml 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 1g in 5ml of sterile aqueous solution for the continuation of treatment of patients with internal contamination with plutonium, americium or curium.

(ii) goods to be purchased by the Commonwealth from X-GEN Pharmaceuticals Inc. P.O. Box 445 Big Flats, New York 14814 and consisting of:

2000 vials of Streptomycin for injection USP 1gram/vial, 10 vials per carton;

(iii) goods to be purchased by the Commonwealth from ICN Pharmaceuticals, Inc. 3300 Hyland Avenue Costa Mesa, California 92626 and consisting of:

100 vials, each vial containing 1.2 grams ribavirin in 12mL phosphate buffer solution,(1mL ribavirin solution for IV injection contains 0.369mg sodium hydrogenphosphate, 8.718mg potassium hydrogenphosphate and water for injection.)

1. Period of exemption

This Exemption commences on the day after the day it is registered on the Federal Register of Legislative Instruments, and ends on:

(a) 30 April 2015; or

(b) for the individual goods, when:

·The goods described at paragraphs 1(i) (a)-(c) receive a marketing approval in Australia for treatment for decorporation of transuranium heavy metal radionuclides;

·The goods described at paragraph 1(ii) receive a marketing approval in Australia for the treatment of plague infection;

·The goods described at paragraph 1(iii) receive a marketing approval in Australia for the treatment of viral haemorrhagic fever;

whichever occurs first.

Note 1                      This Exemption takes effect on the day after the day it is registered on the Federal Register of Legislative Instruments.

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

1. Conditions

The exemption is subject to the following conditions:

(a)the goods must be purchased and imported by the Commonwealth;

(b)the goods are only to be used in humans for the relevant indications as outlined for each good in paragraph 2(b);

(c)the goods must be purchased from the companies as described in 1;

(d)the goods must be stored under the direction of the Secretary of the Australian Government 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 to be 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 as directed by the Secretary of the Australian Government  Department of Health and Ageing;

(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.