WORLD TRADE
ORGANIZATIONG/SPS/N/USA/178/Add.2
21 July 2000
(00-3033)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 13 July 2000, has been received from the United States.
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The Food and Drug Administration (FDA) is announcing the availability of a final guidance
for industry entitled (draft guidance notified as part of G/SPS/N/USA/178 - guidance document three
under paragraph 4) "Impurities in New Veterinary Drug Substances''.  This guidance has been
developed for veterinary use by the International Cooperation on Harmonization of Technical
Requirements for Registration of Veterinary Medicinal Products.  The guidance is intended to assist in
developing registration applications for approval of veterinary medicinal products submitted to theEuropean Union, Japan, and the United States.
Submit written comments at any time.  Instructio ns for commenting are in the full text of this
addendum and the original proposal which are available from the US SPS Enquiry Point.
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