Therapeutic Goods (Emergency) Exemption 2005 (No. 1) (Cth)

Therapeutic Goods (Emergency) Exemption 2005 (No.1)

I, CHRISTOPHER MAURICE PYNE, Parliamentary Secretary to the Minister for Health and Ageing;

(a) acting under section 18A(1), and paragraph 18A(2)(a), 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 the Schedule of this instrument from the operation of Division 2 of Part 3-2 of the Therapeutic Goods Act 1989, with effect from the date mentioned in the Schedule, for the period mentioned in the Schedule and subject to the conditions mentioned in the Schedule.

Dated  January 19,                  2005

Christopher Pyne

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1 Exemption

1. Goods exempted

The following goods are exempted:

(a)         Product:          Reactive Skin Decontamination Lotion

Presentation:    Pouches containing 21ml of Reactive Skin Decontamination Lotion on a sponge applicator, with 0.1722g/ml Dekon 139 Active Ingredient, intended to remove or neutralise chemical warfare agents from the skin.

Quantity:         30,000

(b)         Product:          Reactive Skin Decontamination Lotion

Presentation:    Pouches containing 42ml of Reactive Skin Decontamination Lotion on a sponge applicator, with 0.1722g/ml Dekon 139 Active Ingredient, intended to remove or neutralise chemical warfare agents from the skin.

Quantity:         10,000

(c)         Product:          Reactive Skin Decontamination Lotion

Presentation:    Bottles containing 500ml of Reactive Skin Decontamination Lotion, with 0.1722g/ml Dekon 139 Active Ingredient, intended to remove or neutralise chemical warfare agents from the skin.

Quantity:         2,000

The goods at (a), (b) and (c) above are manufactured by:

Therapex, Division of E-Z-M Canada Inc

11065 L. H. Lafontane, ANJOU, QC H1J 2Z4

The goods at (a), (b) and (c) above are imported on behalf of Emergency Management Australia by:

Counter Terrorism Solutions – Asia Pacific Pty Ltd

26 Cintra Road

Bowen Hills  QLD  4006

1. Period of exemption

This exemption takes effect on the day it is made and ends on 31 December 2009.

Note 1This exemption takes effect on the day it is made (see paragraph 18A(3)(a) of the Therapeutic Goods Act 1989 (the Act))

Note 2Subsections 18A (4) and (5) of the Act make further provision for cessation of an exemption

1. Conditions

This exemption is subject to the following conditions:

(a)the goods must be purchased by Emergency Management Australia and used only for the removal or neutralisation of chemical warfare agents from the skin;

(b)the goods are to be imported on behalf of Emergency Management Australia by the importer named in Item 1 above;

(c)the goods must be imported from the manufacturer named in Item 1 above;

(d)any importation of the goods is first approved, in writing, by the Secretary (to ensure that the total amount of exempt Reactive Skin Decontamination Lotion supplied in 21ml or 42ml pouches, or in 500ml bottles does not exceed the quantities permitted under Item 1 of this Schedule);

(e)the goods are to be stored under the written 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);

(f)the goods are to be distributed from the stockpile and used only in a manner approved, in writing, by the Secretary of the Australian Government Department of Health and Ageing;

(g)records in relation to the distribution and supply of the goods must be 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;

(h)the goods must be disposed of in accordance with the Therapeutic Goods Regulations 1990; and

(i)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.

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