Therapeutic Goods (Emergency) Exemption 2004 (No. 2) (Cth)

Therapeutic Goods (Emergency) Exemption 2004 (No2)

I, PATRICIA MARY WORTH, Parliamentary Secretary to the Minister for Health and Ageing;

(a) acting under section 18A of the Therapeutic Goods Act 1989; 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 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   fourth day of June   2004

Patricia Mary Worth

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

The following goods are exempted:

(a) 2,670,500 of 100mg tablets of doxycycline (Doxyhexal), (381,500 individual packets, 7 tablets per packet); and

(b) entered on the Australian Register of Therapeutic Goods for approved use in other indications, with the entry number of number 66302.

1. Period of exemption

This exemption ends on 31 May 2010, or when the product achieves marketing approval in Australia for the prevention and treatment of anthrax infection in humans, 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 following conditions apply:

(a)the goods must be purchased by the Commonwealth for the prevention and treatment of anthrax infection in humans;

(b)the goods will only be used under this exemption instrument for the prevention and treatment of anthrax infection in humans;

(c)the goods must be supplied by Hexal Australia Pty Ltd, Level 4, Suite 1-6, 100 Harris Street, Pyrmont NSW 2009;

(d)the goods are 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 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 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 of the Australian Government Department of Health and Ageing; and

(iii)for not less than 10 years;

(g)the goods are 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.

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