Therapeutic Goods (Emergency) Exemption 2008 (No. 3) (Cth)
Therapeutic Goods (Emergency) Exemption 2008 (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 Therapeutic Goods Act 1989, for the period mentioned in item 2 of Schedule 1, subject to the conditions mentioned in item 3 of Schedule 1.
Dated this 14th day of July 2008
JAN MCLUCAS
Parliamentary Secretary to the Minister for Health and Ageing
Schedule 1 Exemption
1. Therapeutic Goods exempted (“the Goods”)
The following goods are exempted:
(a) 500 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), manufactured by Pfizer Manufacturing Belgium, Rijksweg 12, PUURS 2870, Belgium.
(b) 200 bottles of botulinum antitoxin, each containing 250mL of solution for intravenous (IV) infusion, where each 1mL of the solution contains:
(i) Equine protein with antitoxin against the neurotoxins produced by Clostridium botulinum (max 170mg; Type A 170 I.U., Type B 500 I.U. and Type E 50 I.U. and
(ii) Phenol, max 0.025mg; and
(iii) Sodium chloride, water for injection.
The botulinum antitoxin is manufactured by Novartis Vaccines and Diagnostics GmbH & Co. KG, Emil von Behring Str.76 and 79, 35041 Marburg, Germany.
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) 31st July 2015; or
(b) The date when the Goods are entered on the Australian Register of Therapeutic Goods with an indication commensurate with:
(i) in the case of cidofovir, the treatment of complications of vaccination against smallpox and suspected/proven smallpox infection.
(ii) in the case of botilinum antitoxin, the post-exposure prophylaxis of persons exposed to botulinum toxin, or the treatment of botulism.
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
The exemption is subject to the following conditions:
(a)the Goods must be purchased by the Commonwealth;
(b)the Goods are to be purchased from:
(i)in the case of botulinum antitoxin, Novartis Vaccines and Diagnostics GmbH & Co. KG, Emil von Behring Str.76 and 79, 35041, Marburg, Germany;
(ii) in the case of cidofovir, Pfizer Australia Pty Ltd, 38-42 Wharf Road, West Ryde NSW 2114;
(c)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);
(d)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;
(e)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;
(f)the Goods must be disposed of in accordance with the Therapeutic Goods Regulations 1990;
(g)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.
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