Exemption of Therapeutic Goods 2002 (Cth)

Exemption of Therapeutic Goods  2002

I, PATRICIA MARY WORTH, Parliamentary Secretary to the Minister for Health and Ageing;

(a) acting under section 18A of the Therapeutic Goods Act 1989; and

(b)   being satisfied that, in the national interest, this Exemption should be made so that the 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 in relation to infection with the smallpox virus;

exempt the goods mentioned in section 1 from the operation of Division 2 of Part 3-2 of the Therapeutic Goods Act 1989, subject to the conditions mentioned in section 2.

Dated 19 November 2002

PATRICIA MARY WORTH

Parliamentary Secretary to the Minister for Health and Ageing

1. Goods

The goods are Vaccinia vaccine:

(a)    consisting of 3 mL multidose vials each filled with 0.3 mL of Vaccinia virus suspension (Elstree strain) containing ≥10⁸ poxviriade specific pock-forming units; and

(b)    manufactured by Aventis Pasteur SA, 2 Avenue Pont Pasteur, F-69367, Lyon, Cedex 07, France; and

(c)    supplied, together with 100 bifurcated needles per vial, by Aventis Pasteur Pty Limited, 29-31 Solent Circuit, Baulkham Hills NSW 2153, Australia.

1. Conditions

The exemption is subject to the following conditions:

(a)    not more than 550 vials of the goods are exempt;

(b)    the goods may be imported only by Aventis Pasteur Pty Limited, of 29‑31 Solent Circuit, Baulkham Hills, NSW 2153 and must be supplied to the Commonwealth of Australia;

(c)    the goods must be stored under the direction of the Secretary of the Department of Health and Ageing (including 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);

(d)    the goods may be supplied from the stockpile, and used, only in a manner approved, in writing, by the Secretary of the Department of Health and Ageing;

(e)    the goods may be used only by medical practitioners or nursing staff registered in a State or Territory, who have been trained in the appropriate vaccination technique relating to the properties of the goods;

(f)    if, following use for vaccination in an individual, a bifurcated needle is inserted again into a vial of vaccine, that vial must not be used for any further vaccinations;

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

(i)    for not less than 10 years by the Chief Health Officer in each of the States and Territories in which the goods are used; and

(ii)    in a manner directed by the Secretary of the 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 the 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.

Note   This exemption:

(a) takes effect on the day it is made (see paragraph 18A (3) (a) of the Therapeutic Goods Act 1989); and

(b) ceases to have effect when it is revoked or when the goods mentioned in section 1 become registered or listed goods (see subsections 18A (4) and (5) of the Therapeutic Goods Act 1989).