Therapeutic Goods (Emergency) Exemption 2007 (No. 3) (Cth)

Therapeutic Goods (Emergency) Exemption 2007 (No 3)

I, BRETT MASON, 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 instrument 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   5^th day of  July 2007

Brett Mason

Parliamentary Secretary to the Minister for Health and Ageing

Schedule 1           Exemption

1.         Goods exempted

The following goods are exempted:

(i) goods to be purchased and imported by the Commonwealth from Akorn Inc., located at 2500 Millbrook Drive, Buffalo Grove, Illinois, USA, 60089-4694; manufactured by Taylor Pharmaceuticals, Decatur, Illinois, USA, and consisting of:

A total of 4,000 (3mL) ampoules (in boxes of 10) of British anti-Lewisite (BAL) in oil, [dimercaprol injection, USP]; each 1mL containing 100mg dimercaprol in 200mg benzyl benzoate and 700mg peanut oil;

(ii) goods to be purchased and imported by the Commonwealth from Emergent BioDefence Operation Lansing Inc. located at 2500 North Martin Luther King Jr. Blvd., Lansing, Michigan, USA, 489906 and consisting of:

A total of 3,000 (5mL) multidose vials, 10 doses/vial of BioThrax (anthrax vaccine adsorbed);

(iii) goods to be purchased and imported by the Commonwealth from Recip Stockholm AB, located at Branningevagen 10-24, SE-120, 54 Arsta, Sweden. and consisting of:

A total of 150,000 tablets of ThyroSafe (potassium iodide USP) 65mg tablets, in packets of 10 tablets.

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) 31st July 2015; or

(b) in respect of the individual goods described in subparagraphs 1(i), (ii) and (iii) above:

·The date when the goods described at subparagraph 1(i) are entered on the Australian Register of Therapeutic Goods with an indication for the treatment of arsenic poisoning ;

·The date when the goods described at subparagraph 1(ii) are entered on the Australian Register of Therapeutic Goods with an indication for vaccination against anthrax infection;

·The date when the goods described at subparagraph 1(iii) are entered on the Australian Register of Therapeutic Goods with an indication for the prophylactic treatment of contamination by radioactive isotopes;

whichever occurs first in relation to each of the three goods described in this paragraph.

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

The exemption is subject to the following conditions:

(a)the goods must be purchased and imported by the Commonwealth;

(b)the goods are only to be used in humans for the relevant indications as outlined for each good in paragraph 2(b);

(c)the goods must be purchased from the companies as described in 1;

(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.