Therapeutic Goods (Emergency) Exemption 2004 (No. 1) (Cth)

Therapeutic Goods (Emergency) Exemption 2004 (No1)

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 (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   fourth               day of  June                   2004

Patricia Mary Worth

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

The following goods are exempted:

2,000 vials of freeze dried (lyophilised) Smallpox Vaccine, equivalent to 200,000 doses of the Vaccine, with the following specifications:

(a) The freeze dried (lyophilised) Smallpox Vaccine consists of:

(i)purified vaccinia virus, based on the New York City Board of Health strain;

(ii)produced in Vero cell culture substrate;

(iii)supplied as a sterile, freeze dried (lyophilised) formulation, with a minimum of 1 x 10⁸ plaque forming units (PFU)/mL of live vaccinia virus;

(iv)packaged in units of no less than 100 doses of vaccine per vial; and

(b) Each vial of freeze dried (lyophilised) Smallpox Vaccine contains no less than 100 doses of Vaccine upon reconstitution, in a minimum of 0.3 mL suspension; and

(c) the goods are manufactured by ACAMBIS, a company registered in the USA and purchased from Baxter Healthcare SA of Hertistrasse 2, CH-8304 Wallisellen, Switzerland.

1. Period of exemption

This Exemption ends on 30 April 2010, or when the product receives a marketing approval in Australia for the prevention and early treatment of suspected smallpox infection in humans, 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 prevention of smallpox virus infection in humans and the early treatment of suspected smallpox virus infection in humans;

(b)the goods will only be used for the prevention of smallpox virus infection in humans and early treatment of suspected smallpox virus infection in humans;

(c)the goods must be imported from Baxter Healthcare SA of Hertistrasse 2, CH-8304, Wallisellen, Switzerland;

(d)the goods are 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 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.