Therapeutic Goods (Emergency) Exemption 2002 (No. 2) (Cth)

Therapeutic Goods (Emergency) Exemption 2002 (No. 2)

Therapeutic Goods Act 1989

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 12 December 2002

PATRICIA MARY WORTH

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1          Exemption

1              Goods exempted

The following goods are exempted:

(a) ATOX ComboPen autoinjectors (other than autoinjectors that, by virtue of item 9 in Schedule 5A to the Therapeutic Goods Regulations 1990, are exempt under subsection 18 (1) of the Act and, after 31 December 2002, are exempt under subsection 18A (1) of the Act by virtue of an exemption other than this Exemption) that individually contain:

(i)    220mg/2mL of obidoxime chloride; and

(ii)    2mg/2mL of atropine sulphate;

(b) AtroPen autoinjectors (other than autoinjectors that, by virtue of item 9 in Schedule 5A to the Therapeutic Goods Regulations 1990, are exempt under subsection 18 (1) of the Act and, after 31 December 2002, are exempt under subsection 18A (1) of the Act by virtue of an exemption other than this Exemption) that individually contain 2mg/2mL of atropine as atropine sulphate.

2              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.

3              Conditions

The following conditions apply:

(a)    in relation to ATOX ComboPen autoinjectors:

(i) no more than 40 000 autoinjectors (including autoinjectors that are exempt under subsection 18 (1) of the Act) are exempt under Division 1 of Part 3‑2 of the Act; and

(ii)    any importation of the autoinjectors is first approved, in writing, by the Secretary (to ensure that the total number of exempt ComboPen autoinjectors does not exceed 40 000);

(b)    in relation to AtroPen autoinjectors:

(i) no more than 10 000 autoinjectors (including autoinjectors that are exempt under subsection 18 (1) of the Act) are exempt under Division 1 of Part 3‑2 of the Act; and

(ii)    any importation of the autoinjectors is first approved, in writing, by the Secretary (to ensure that the total number of exempt AtroPen autoinjectors does not exceed 10 000);

(c)    the goods are imported from Meridian Medical Technologies in the United States of America;

(d)    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);

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

(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; and

(iii)    for not less than 10 years;

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

(h)    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.