Therapeutic Goods (Emergency) Exemption 2006 (No. 1) (Cth)

Therapeutic Goods (Emergency) Exemption 2006 (No1)

I, CHRISTOPHER PYNE, 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 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  3rd February  2006

Christopher Pyne

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

The following goods are exempted:

200 bottles each containing 250mL of solution for intravenous (IV) infusion, where

(a) each 1mL of the solution contains:

(i)Equine protein with antitoxin against the neurotoxins produced by Clostridium botulinum (max 170mg; Type A 170 I.U., Type B 500 I.U. and Type E 50 I.U. and

(ii)Phenol, max 0.025mg; and

(iii)Sodium chloride, water for injection; and

(b) the goods are manufactured by Chiron Behring GmbH , Emil von Behring Str., 35041, Marburg, Germany.

1. Period of exemption

This Exemption ends on:

(a) 31 January 2012; or

(b) when the goods receive a marketing approval in Australia for the post-exposure prophylaxis of persons exposed to botulinum toxin, or the treatment of botulism;

whichever occurs first.

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

The exemption is subject to the following conditions:

(a)the goods must be purchased by the Commonwealth for the treatment of post-exposure prophylaxis of persons exposed to botulinum toxin, or the treatment of botulism;

(b)the goods are only to be used in humans for the indications as outlined in (a);

(c)the goods must be imported from Chiron Behring GmbH , Emil von Behring Str., 35041, Marburg, Germany;

(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:

(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 from the date of supply of the goods.;

(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.