. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/MAC/4/Rev.1 
31 August 2005 
 (05-3799) 
Committee on Sanitary a nd Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
Revision
 
 
1. Member to Agreement notifying:  MACAO, CHINA  
If applicable, name of local government involved:   
2. Agency responsible:  Department of Health  
3. Products covered (provide tariff item number(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Medicines derived from bovine materials (HC 30).  
4. Regions or countries likely to be affected, to the extent relevant or practicable:  All 
countries, especially where a BSE case has been reported.  
5. Title, language and number of pages of the notified document:  Chief Executive 
Decision No. 120/2005.  
6. Description of content:   
(1) Suspension of importation for all medicines containing high-infectivity tissues listed 
on the "WTO Guidelines on Transmissible S pongiform Encephalopathies in relation to 
Biological and Pharmaceutical Products." 
(2) Suspension of the importation for all medicines where their countries of origin have 
had an outbreak incidence of BSE, except: 
- in an urgent situation and appr oved by Department of Health; 
- the medicine complies with the requireme nt of WHO guideline for minimizing the 
risk of transmission of animal spongiform encephalopathies through medicinal 
products or other equivalent criteria, a nd approved by the Department of Health; 
- the medicine only containing tissues with no detected infectivity listed on the 
"WHO Guidelines on Transmissible Spongifo rm Encephalopathies in relation to 
Biological and Pharmaceutical Products." 
(3) All manufacturers who produce bovine-containing medicines should comply with 
GMP for producing such products. 
This Chief Executive Decision replaces the measures notified on 6 November 2001 under 
G/SPS/N/MAC/4, which entered into force on 2 July 2001.  
7. Objective and rationale: [    ] food safety,  [    ] animal health,  [    ] plant protection, 
[ X ] protect humans from animal/plant pest or disease, [    ] protect territory from 
other damage from pests   G/SPS/N/MAC/4/Rev.1 
Page 2  
 
 8. International standard, guideline or recommendation: 
[   ] Codex Alimentarius Commission,  [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention,  [   ] None 
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   
- "WHO Guidelines on Transmissible Spongiform Encephalopathies in relation to 
Biological and Pharmaceutical Products." – WHO 
- "Note for guidance on minimizing the risk of transmitting animal spongiform 
encephalopathy agents via human and ve terinary medicinal products." - EMEA 
9. Relevant documents and language(s) in which these are available:  Macao Special 
Administrative Region Bulletin No. 18, Seri es I, 2005 (available in Chinese and Portuguese)
10. Proposed date of adoption:  26 April 2005 (date of adoption)  
11. Proposed date of entry into force:  2 May 2005 (date of entry into force)  
12. Final date for comments:  Not applicable  
Agency or authority designated to handle comments:  [    ] National notification 
authority, [    ] National enquiry point, or add ress, fax number and E-mail address (if 
available) of other body:   
13. Texts available from:  [    ] National notification authority, [  X ] National enquiry 
point, or address, fax number and E-mail address (if available) of other body:   
Department of Health 
Caixa Postal 3002 Macao SAR China