. /.  
WORLD TRADE  
ORGANIZATION   
G/TBT/N/AUS/35 
26 May 2004 
 
 (04-2260) 
Committee on Technical Barriers to Trade Original:  English 
  
NOTIFICATION 
 
The following notification is being circ ulated 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 
PO Box 100 
Woden  ACT  2606 AUSTRALIA tel:  + 61 2 6232 8740 fax:  + 61 2 6232 8687 
website:  www.tga.gov.au 
 
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 app licable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable): Diagnostic Goods of 
Human Origin 
5. Title, number of pages and language(s) of the notified document:   Therapeutic Goods 
Order No 34A – Standard for Di agnostic Goods Of Human Origin 
6. Description of content: Describes, in respect to quality and method of preparation, the 
standard for goods which contain materials of human origin and which are intended as 
reagents for in vitro and ex vivo diagnostic tests.  The Order also specifies how such goods 
shall be labelled and the procedures to be ca rried out in the production of such goods. 
The proposal seeks to amend Therapeutic Goods Or der No 34, in force since 1990, to revise 
the scope to include ex vivo diagnostics that contain materials of human origin and to 
include updated technical requirements, current practices and test methods.  Any reference 
to the previously published Therapeutic Goods Order No 34 Standard for Diagnostic Goods 
of Human Origin will be removed.   
7. Objective and rationale, including the na ture of urgent problems where applicable:  
Protection of human health and safety.  The pur pose of this regulation is to have a national 
regulatory requirement and to ensure the saf ety, quality and efficacy of diagnostic goods 
that contain materials of human origin in Au stralia.  The proposed amendment to TGO 34 G/TBT/N/AUS/35 
page 2  
 
 
Standard for Diagnostic Goods of Human Origin will update the standards and references 
for diagnostic goods of human origin which are intended as reagents for in vitro and ex vivo 
diagnostic kits. 
8. Relevant documents:  Relevant documents refere nced within the Order. 
9. Proposed date of adoption:  To be determined. 
Proposed date of entry into force:  The Order will be published in the Commonwealth of 
Australia Gazette  GN 21 of 26 May 2004 and will comme nce six months from the date of 
gazettal. 
10. Final date for comments:   30 July 2004 
11. Texts available from: A copy of the draft Therapeutic Goods Order No 34A- Standard for 
Diagnostic Goods of Human Origin can be obtained from the Policy & Regulatory Liaison 
Section, Office of Devices, Blood & Tissues, Therapeutic Goods Administration: Fax No 
+61 2 6232 8687. 
The text is also available at : http://www.tga.gov.au/devices/devices.htm