. /.WORLD TRADE
ORGANIZATIONG/TBT/N/AUS/12
2 October 2002
(02-5300)
Committee on Technical Barriers to Trade Original:  English
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   AUSTRALIA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Department of Health and Ageing, Therapeutic Goods
Administration
Name and address (including telephone and fax numbers, e-mail and web-site
addresses, if available) of  agency or authority designated to handle comments
regarding the notification shall be indicated if different from above:           
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Medicines with specified
ingredients
5. Title, number of pages and language(s) of the notified document:   Therapeutic Goods
Order No. 65 Child-Resistant Packaging for Therapeutic Goods (23 pages, in English)
6. Description of content:   The proposal seeks to update existing requirements for child-
resistant packaging for therapeutic goods in Australia in accordance with the transition
arrangements specified in the Order.  Identifies medicines for which child-resistantpackaging is mandatory, and describes the acceptable standards for this.  The acceptance
criterion for new child-resistant packaging will be evidence of compliance with any one or
more of a range of specified national or international Standards while the status of
packaging previously approved as child-resistant will not change.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Protection of human health and safety, and to minimize accidental poisoning in children.
8. Relevant documents:   Publication in which the notification is published when adopted:
Commonwealth of Australia Gazette.
Referenced international and Australian Standards: ISO 8317:1989 Child-resistantpackaging – Requirements and testing procedures for reclosable packages; BS EN
28317:1993 Child-resistant packaging – Requirements and testing procedures for reclosable
packages; CSA Z76.1-99 Reclosable Child-Resistant Packages; US 16 CFR 1700.15 Poison
prevention packaging standards and US CFR 1700.20 Testing procedure for special
packaging; and AS 1928-2001 Child-resistant packages.
9. Proposed date of adoption:  To be determined.
Proposed date of entry into force:G/TBT/N/AUS/12
Page 2
10. Final date for comments:   30 November 2002
11. Texts available from:  National enquiry point [     ] or address, telephone and fax
numbers, e-mail and web-site addresses, if available of the other body:  A copy of the
draft Therapeutic Goods Order No. 65 Child-resistant packaging for therapeutic goods  is
available from the Secretariat & Recalls Section, Conformity Assessment Branch,
Therapeutic Goods Administration, PO Box 100 Woden ACT 2606;
Telephone No. +61 2 6232 8661; Fax No. +61 2 6232 8687.  The text is also available at :http://www.health.gov.au/tga/new/new.htm