Therapeutic Goods (Emergency) Exemption 2008 (No. 4) (Cth)
Therapeutic Goods (Emergency) Exemption 2008 (No 4)
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 Therapeutic Goods Act 1989, for the period mentioned in item 2 of Schedule 1, subject to the conditions mentioned in item 3 of Schedule 1.
Dated this 11th day of November 2008
Signed
Jan McLucas
Parliamentary Secretary to the Minister for Health and Ageing
Schedule 1 Exemption
1. Therapeutic Goods exempted (“the Goods”)
The following goods are exempted:
Name: CNJ-016, Vaccinia Immune Globulin Intravenous (Human) (VIGIV)
Description: CNJ-016, Vaccinia Immune Globulin Intravenous (Human) (VIGIV) is a solvent/detergent-treated sterile solution of purified gamma globulin (IgG) fraction of human plasma containing antibodies to the vaccinia virus. Stabilised with 10% maltose and 0.03% polysorbate 80 (pH 5.0-6.5) and containing no preservatives.
Manufacturer: Cangene Corporation, 155 Innovation Drive, Winnipeg, MB R3YT 5Y3 Canada.
Packaging: 15mL vials, filled with sufficient overage to ensure a finished product potency of not less than 50,000 units per vial over the shelf-life of the product.
Dose: For intravenous administration, with a typical single dose of 6000 U/Kg.
Quantity: 500 15mL vials from lot number 10804313.
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) 30th April 2016; or
(b) The date when the Goods are entered on the Australian Register of Therapeutic Goods with an indication commensurate with the treatment of complications of vaccination against infection by the smallpox virus and treatment of suspected or proven infection with the smallpox virus itself;
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.
Conditions
The exemption is subject to the following conditions:
(a)no more than 500 15mL vials of 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 for the treatment of vaccinia infection (the virus used to vaccinate against smallpox) or suspected or proven smallpox virus infection in humans;
(d)the goods must be imported and purchased from Cangene Corporation, 155 Innovation Drive, Winnipeg, Manitoba, Canada, R3T 5Y3;
(e)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);
(f)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;
(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;
(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.
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