Therapeutic Goods (Emergency) Exemption 2007 (No. 4) (Cth)

Therapeutic Goods (Emergency) Exemption 2007 (No 4)

I, BRETT MASON, 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 this instrument 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    16th    day of    October   2007

Brett Mason

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

The following goods are exempted:

A total of 80,000 blister packs each containing seven (7) 100mg tablets of doxycycline tablets (DOXYHEXAL) as monohydrate; AUST R number 66302

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)        31st October 2015; or

(b)        The date when the goods are entered on the Australian Register of Therapeutic Goods with an indication of treatment of inhalational anthrax 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.

1. 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 Novartis Pharmaceuticals Australia Pty. Ltd. Trading as Sandoz Pty. Ltd. (the Australian sponsor of the product, which is registered in Australia for other indications);

(c)the goods are only to be used for the indication of treatment of inhalational anthrax infection in humans;

(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.