Therapeutic Goods (Emergency) Exemption 2009 (No. 2) (Cth)

Therapeutic Goods (Emergency) Exemption 2009 (No 2)

I, JAN MCLUCAS, 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 Schedule 1 from the operation of Division 2 of Part 3-2 of the Act, for the period mentioned in item 2 of Schedule 1, subject to the conditions mentioned in item 3 of Schedule 1.

Dated this         26^th      day of              May                   2009

(signed by)

Jan McLucas

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Therapeutic Goods exempted (“the Goods”)

The following goods set out in paragraph (a) and manufactured by the company set out in paragraph (b) are exempted:

(a) Name and description: Zink-Trinatrium-Pentetat (Zn-DTPA) 400 packets each containing 5 ampoules (2000 ampoules in total). Each ampoule has 5mL injection solution containing 1055mg of trisodium zinc pentetate (Zn-DTPA).

(b) Manufacturer:          Heyl Chem.-pharm. Fabrik

GmbH & Co. KG

Goerzallee 253

14167 Berlin

Germany

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)        30  April 2017; or

(b)        the date when the Goods are entered on the Australian Register of Therapeutic Goods with an indication commensurate with use as a chelating agent for the treatment of transuranium heavy metal nuclides (americium, plutonium, curium, californium, berkelium) poisoning.

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

This Exemption is subject to the following conditions:

(a)no more than 400 packets each containing 5 ampoules (2000 ampoules in total) of Zn-DTPA (‘the goods’) are to be exempted by this instrument;

(b)the Goods must be purchased and imported by the Commonwealth;

(c)the Goods must only be used as a chelating agent for the treatment of transuranium heavy metal nuclides (americium, plutonium, curium, californium, berkelium) poisoning.

(d)the Goods must be imported and purchased from Heyl Chem.-pharm. Fabrik GmbH & Co. KG, Goerzallee 253, 14167 Berlin, Germany.

(e)the Goods must be stored in the National Medical Stockpile 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);

(f)the Goods are to be supplied from the National Medical 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 as directed by the Secretary of the Australian Government Department of Health and Ageing;

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

(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 Regulations.