Therapeutic Goods (Emergency) Exemption 2006 (No. 2) (Cth)

Therapeutic Goods (Emergency) Exemption 2006 (No 2)

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 this 1st day of  November 2006

Christopher Pyne

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

(a) The following goods are exempted:

2000 single use vials each containing cidofovir (VISTIDE) 375mg in 5mL water for injection (with sodium chloride or hydrochloric acid to adjust pH to 7.4).  

(b) The goods are manufactured by Pfizer Manufacturing Belgium, Rijksweg 12, PUURS 2870, Belgium.

1. Period of exemption

This Exemption ends on:

(a) 30 September 2014; or

(b) when the goods receive a marketing approval in Australia for the treatment of complications of vaccination against infection by the smallpox virus, and treatment of infection with the smallpox virus itself;

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 complications of vaccination against infection by the smallpox virus, and treatment of infection with the smallpox virus itself;

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

(c)the goods must be imported from Pfizer Manufacturing Belgium, Rijksweg 12, PUURS 2870, Belgium, by Pfizer Australia Pty Ltd, 38-42 Wharf Road, West Ryde  NSW  2114;

(d)the goods must be stored:

(i) 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); and

(ii) in compliance with the storage conditions detailed in the Australian Product Information document for VISTIDE, ATRG No. 63050;

(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.