Therapeutic Goods (Emergency) Exemption 2007 (No. 1) (Cth)

Therapeutic Goods (Emergency) Exemption 2007 (No 1)

I, CHRISTOPHER PYNE, Assistant Minister 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 22nd day of February 2007

Christopher Pyne

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

(a) The following goods are exempted:

100,000 doses of monovalent split virion influenza vaccine, with the following specifications:

(i)         10 dose glass vials (0.5mL/dose), packed in boxes of 10 vials.

(ii)        Labelled as: H5N1 adjuvanted vaccine, 30 micrograms HA per             0.5mL dose.

(iii)       each dose contains 30 micrograms influenza A virus subtype H5N1 HA A/Vietnam adjuvanted with 600 micrograms aluminium hydroxide, suspension for injection. The lower fiducial limit for the HA content will be greater than or equal to 24 micrograms per 0.5mL dose.

(iv)       Excipients: buffer solution of sodium chloride, potassium chloride, disodium phosphate dehydrate, potassium dihydrogen phosphate, water and thiomersal.

(v)        Residual substances: neomycin, octoxinol 9, formaldehyde.

(b) The goods are manufactured by Sanofi Pasteur, 2 av. Pont Pasteur, 69367 Lyon cedex 07 France.

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) 31 March 2015; or

(b) when the goods receive a marketing approval in Australia for vaccination against infection with the H5N1 influenza virus;

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 by the Commonwealth for vaccination against the H5N1 influenza virus;

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

(c)the goods must be imported from Sanofi Pasteur, 2 av. Pont Pasteur, 69367 Lyon cedex 07 France, by Sanofi Pasteur; Talavera Corporate Centre, Building D, 12-24 Talavera Road, Macquarie Park NSW 2113;

(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.