Therapeutic Goods (Emergency) Exemption 2006 (No. 3) (Cth)

Therapeutic Goods (Emergency) Exemption 2006 (No 3)

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 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 Schedule 1 to this document from the operation of Division 2 of Part 3-2 of the Act, subject to the conditions mentioned in item 3 of that Schedule.

Dated this 30th 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:

Name:    Vaccinia Immune Globulin (Human), a sterile solution of purified gamma globulin (IgG) fraction of human plasma. Stabilised with 10% maltose and 0.03% polysorbate 80 (pH 5.0-6.5).

Manufacturer:               Cangene Corporation, 104 Chancellor Matheson Road, Winnipeg, Manitoba, Canada, R3T 5Y3.

Packaging:                    15mL vials; not less than 50,000 units per vial.

Dose:   For intravenous administration, 6000 U/Kg, typically as a single dose.

Quantity:                       500 vials.

1. Period of exemption

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

(a) 31 August 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)no more than 500 15mL vials of Vaccinia Immunoglobulin as described in Item 1 are to be exempted by this instrument;

(b)the goods must be purchased and imported by the Commonwealth for the prevention and treatment of Vaccinia or smallpox infection in humans;

(c)the goods will only be used for the treatment of vaccinia infection (the virus used to vaccinate against smallpox) or suspected or proven smallpox virus infection in humans;

(d)the goods must be imported from Cangene Corporation, 104 Chancellor Matheson Road, Winnipeg, Manitoba, Canada, R3T 5Y3;

(e)the goods are stored under the direction of the Secretary of the Department of Health and Ageing (the Secretary) (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);

(f)the goods are supplied from the stockpile, and used, only in a manner approved, in writing, by the Secretary;

(g)records in relation to the distribution and supply of the goods are 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; and

(iii)for not less than 10 years;

(h)the goods are disposed of in accordance with the Therapeutic Goods Regulations 1990;

(i)the goods are imported, supplied and used on the understanding that a direction by the Secretary that the goods be disposed of in accordance with the Therapeutic Goods Regulations 1990, creates no entitlement in any person to compensation in relation to the disposal.

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