Therapeutic Goods (Emergency) Exemption 2006 (No. 4) (Cth)

Therapeutic Goods (Emergency) Exemption 2006 (No 4)

I, CHRISTOPHER PYNE, 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 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 this 20th day of  December 2006

Christopher Pyne

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

(a) The following goods are exempted:

300 CYANOKIT procedure packs, each consisting of:

·Two 250mL colourless glass bottles with bromobutyl stopper and transfer kit, each bottle containing 2.5g hydroxocobalamin lyophilisate for parenteral use (IV) and hydrochloric acid qsp pH = 4;

·Two transfer devices for the reconstitution of the lyophilisate;

·An intravenous infusion set; and

·A short catheter for administration to children.

(b) The finished goods are manufactured by Merck Santé s.a.s., Centre de Production de Semoy, 2 rue du Pressoir Vert, 45400, Semoy, FRANCE

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 November 2014; or

(b) when the goods receive a marketing approval in Australia for the treatment of cyanide poisoning;

whichever occurs first.

Note 1      This exemption takes effect the day after it is registered in 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

The exemption is subject to the following conditions:

(a)the goods must be purchased by the Office of Health Protection, Australian Government Department of Health and Ageing for the treatment of cyanide poisoning;

(b)the goods are only to be used in humans for the indication as outlined in (a);

(c)the goods must be imported by the Office of Health Protection, Australian Government Department of Health and Ageing from Merck Santé s.a.s., Centre de Production de Semoy, 2 rue du Pressoir Vert, 45400, Semoy, FRANCE;

(d)the goods must be 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 to be 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 must be kept as directed by the Secretary of the Australian Government  Department of Health and Ageing;

(g)the goods must be 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.