WORLD TRADE
ORGANIZATIONG/SPS/N/USA/180/Add.1
23 May 2001
(01-2629)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 18 May 2001, has been received from the United States.
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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH); Final Guidance for Industry entitled "Good Clinical Practice" (VICH
GL9);  Availability
The Food and Drug Administration (FDA) is announcing the availability of a final guidance
for industry (No. 85) entitled "Good Clinical Prac tice" (VICH GL9).  This guidance document has
been developed for veterinary use by the International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH).  The final VICH guidance isintended to provide a unified standard for designing, conducting, monitoring, recording, and reporting
studies used in registration applications for approval of veterinary products submitted to the European
Communities, Japan, and the United States.
Submit written comments at any time.  Comments from Members should be submitted
through their VICH representative.  This guidance will be implemented 1 July 2001.
The full text of this addendum, which includes instructions for commenting through the US
VICH representative and the final guidance, are available from the address below.
United States SPS Enquiry Point/Notification Authority:
USDA/FAS/FSTSDATTN: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov
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