Therapeutic Goods (Emergency) Exemption 2002 (No. 4) (Cth)

Therapeutic Goods (Emergency) Exemption 2002 (No. 4)

I, PATRICIA MARY WORTH, Parliamentary Secretary to the Minister for Health and Ageing, acting under subsection 18A(1), and paragraph 18A(2)(a), of the Therapeutic Goods Act 1989 (the Act) make this Exemption of the goods mentioned in Schedule 1, for the period, and subject to the conditions, mentioned in the Schedule.

Dated         seventeenth  of  December   2002

Patricia Mary Worth

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

100mL bottles of amoxycillin powder for reconstitution to amoxycillin suspension of 250mg/5ml.

1. Period of exemption

This Exemption ends on 31 December 2008.

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)no more than 40,000 such bottles are exempt under Division 1 of Part 3–2 of the Act;

(b)the goods are purchased by the Commonwealth;

(c)the goods are only used for the prevention and treatment of inhalation anthrax (post-exposure) in humans;

(d)the goods are imported from a source approved, in writing, by the Secretary;

(e)the goods are stored under the direction of the Secretary (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);

(f)the goods are supplied from the stockpile, and used, only in a manner approved, in writing, by the Secretary;

(g)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; and

(iii)for not less than 10 years;

(h)the goods are disposed of in accordance with the Therapeutic Goods Regulations 1990;

(i)the goods are imported, supplied and used on the understanding that a direction by the Secretary, that the goods be disposed of in accordance with the Therapeutic Goods Regulations 1990, creates no entitlement in any person to compensation in relation to the disposal.

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