. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/178
29 July 1999
(99-3205)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:   UNITED STATES
If applicable, name of local government involved:
2. Agency responsible:    US Food and Drug Administration
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO;  ICS numbers may be provided in addition, where applicable).
Regions or countries likely to be affected, to the extent relevant or practicable:
Veterinary medicinal products
4. Title and number of pages of the notified document: International Cooperation on
Harmonization of Technical Requirements for Registration of Veterinary Medicinal
Products (VICH);  Three Draft Guidance Documents:
1. Impurities in New Veterinary Medicinal Products;
2. Stability Testing for Medicated Premixes; and
3. Impurities in New Veterinary Drug Substances; all with request for comments
(4 pages, plus the 3 guidance documents)
5. Description of content: The Food and Drug Administration (FDA) is announcing the
availability for comment of three draft guidance documents developed by the International
Cooperation on Harmonization of Technical Requirements for Registration of Veterinary
Medicinal Products.  Document 1 provides guidance recommendations for applications formarketing authorizations on the content and qualification of impurities in new veterinary
medicinal products produced from chemical ly synthesized new active substances not
previously registered in a member state.  Document 2 is an annex to the parent guidance
VICH GL3 entitled "Stability Testing of New Drug Substances and Products in the
Veterinary Field".  This draft guidance document is the annex and addresses of therecommendations for stability testing of veterinary medicinal Type A medicated articles
(referred to as medicated premix drug products in the draft guidance) intended for
submission for approval to the European Communities, Japan, and the United States.
Document 3 is draft guidance for industry entitled “Impurities in New Veterinary Drug
Substances” and is intended to assist in developing registration applications for approval ofveterinary medicinal products submitted to the European Communities, Japan and the
United States
6. Objective and rationale:  [  X ] food safety  [ X ] animal health [   ] plant protection
[   ] protect humans from animal/plant pest or  disease  [  ]  protect territory from other
damage from pests
7. An international standard, guidelin e or recommendation does not exist [ X ].
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:G/SPS/N/USA/178
Page 2
8. Relevant documents and language(s) in which these are available:  64 FR 39514,
22 July 1999 (Available in English)
9. Proposed date of adoption:  Will be published as future guidance.
10. Proposed date of entry into force:  Same as paragraph 9
11. Final date for comments:   23 August 1999
Agency or authority designated to handle comme nts:  [  ] National notification authority,
[  ] National enquiry point, or address, fax number and E-mail address (if available) of
other body:   Food and Drug Administration
Detailed instruction on where and how to send commen ts is in the body of the full text – which
will be sent upon request to the address in paragraph 12.
12. Texts available from:  [ X ] National notification authority,  [ X ]  National enquiry point,
or address, fax number and E-mail address (if available) of other body:
US SPS Enquiry Point/Notification Authority:
USDA/FAS/FSTDAttn:  Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720 2239
Fax::  (202) 690 0677E-mail address:  ofsts@fas.usda.gov