Therapeutic Goods (Emergency) Exemption 2009 (No. 3) (Cth)
Therapeutic Goods (Emergency) Exemption 2009 (No 3)
I, JAN MCLUCAS, 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 from the operation of Division 2 of Part 3-2 of the Act, for the period mentioned in item 2 of Schedule 1, subject to the conditions mentioned in item 3 of Schedule 1.
Dated this 25th day of May 2009
(signed by)
Jan McLucas
Parliamentary Secretary to the Minister for Health and Ageing
Schedule 1 Exemption
1. Therapeutic Goods exempted (“the Goods”)
The following goods set out in paragraph (a) and manufactured by the company set out in paragraph (b) are exempted:
(a) Name and description: 100 vials of Virazole injection, each containing 1.2 grams of ribavirin in 12mL phosphate buffer solution for intravenous administration.
(b) Manufacturer: Legacy Pharmaceuticals Switzerland GmbH
Ruhrbergstrasse 21
Birsfelden CH-4127
Switzerland
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) 30 April 2017; or
(b) the date when the Goods are entered on the Australian Register of Therapeutic Goods with an indication commensurate with the treatment of viral haemorrhagic fevers including Lassa Fever, Crimean-Congo Haemorrhagic fever and Hantavirus infection.
whichever occurs first in relation to the Goods.
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.
Conditions
This Exemption is subject to the following conditions:
(a)no more than 100 vials of the Goods are to be exempted by this instrument;
(b)the Goods must be purchased by the Commonwealth but imported by Valeant Pharmaceuticals Australasia Pty Ltd, PO Box 3188, Rhodes NSW 2138 (the Australian agent for the manufacturer referred to in paragraph 1(b)) on behalf of the Commonwealth.
(c)the Goods must only be used for the treatment of viral haemorrhagic fevers including Lassa Fever, Crimean-Congo Haemorrhagic fever and Hantavirus infection.
(d)the Goods must be stored in the National Medical Stockpile 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)once imported, the Goods are to be stored in and supplied from the National Medical 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 (the Regulations); and
(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 Regulations.
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