. /.  WORLD TRADE  
ORGANIZATION   
G/SPS/N/AUS/280 
16 November 2011  
 (11-5905) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  AUSTRALIA 
If applicable, name of local government involved:    
2. Agency responsible:  Australian Government Department  of Agriculture, Fisheries and 
Forestry (DAFF) 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO;  ICS numbers should be provided in addition, where 
applicable):  Veterinary vaccines, other veterinary therapeutics and in vivo veterinary 
products 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Draft guidelines for managing the risk of transmitting 
transmissible spongiform encephalopathies ( TSEs) via veterinary vaccines and other in 
vivo veterinary products.  Language(s):  English  Number of pages:  45 
6. Description of content:  The Australian Government Department of Agriculture, Fisheries 
and Forestry proposes to update its 2005 review of Australia's biosecurity requirements for 
veterinary vaccines, other veterinary therapeuti cs and in vivo veterinary  products in relation 
to transmissible spongiform encephalopathies (TSEs).  
This document is a draft for a 60 day cons ultation period. This review details the 
management of TSE risks associated with va rious raw materials used in veterinary 
therapeutic and vaccine production.  
Adjustments to the review may be necessar y from time to time as scientific knowledge 
continues to grow, international standards e volve and the number of countries reporting 
TSEs changes. 
In addition to the OIE Terrestrial Animal Health Code 2011 Chapters 11.5, 14.9 and the 
OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals 2011, the document 
aims to be consistent, in its general principl es, with the European Union Note for guidance 
on minimizing the risk of transmitting anim al spongiform encephalopathy agents via 
human and veterinary medicinal products and its subsequent revisions by the European 
Medicines Evaluation Agency (EMEA; now know as the European Medicines Agency 
(EMA); EMA/410/01 rev 2 and 3).  G/SPS/N/AUS/280 
Page 2  
 
  7. Objective and rationale:  [ ] food safety, [X] animal health, [ ] plant protection, 
[ ] protect humans from animal/plant pest or disease, [ ] protect territory from other 
damage from pests.    
8. Is there a relevant international stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[X] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)  OIE Terrestrial Animal Health Code 2011 
Chapter 11.5 Bovine spongiform encephalopathy, and Chapter 14.9 Scrapie; and 
the Manual of Diagnostic Tests and Va ccines for Terrestrial Animals 2011: 
Chapter 1.1.8 Principles of veterinary vaccine production.  
[ ] International Plant Protection Convention (e.g. ISPM number)    
[ ] None Does this proposed regulation conform to the relevant international standard?   
 [X] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language (s) in which these are available:  Nil   
10. Proposed date of adoption (dd/mm/yy) :  To be advised. 
Proposed date of publication (dd/mm/yy) :  To be advised. 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  Approximately March 2012 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  9 January 2012 
Agency or authority designated to handle comments:  [X] National Notification 
Authority, [X] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:    
13. Texts available from:  [X] National Notification Authority, [X] National Enquiry 
Point.  Address, fax number and e-mail address (if available) of other body:    
Texts are available at the following web addr ess, or alternatively, from the Australian SPS 
Notification Point:  http://www.daff.gov.au/ba/ira/current-animal/tses  
The Australian SPS Notification Point 
GPO Box 858 
Canberra  ACT  2601 
Australia Fax:  +(61 2) 6272 3678 Email:  sps.contact@daff.gov.au