. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/362
15 December 2000
(00-5488)
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:  Department of Agriculture, Animal and Plant Health Inspection
Service - APHIS
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: Draft Guideline on
Pharmacovigilance of Veterinary Medicinal Products: Management of Adverse Event
Reports, VICH Topic GL24 (2 pages)
5. Description of content: A draft guideline titled "Pharmacovigilance of Veterinary
Medicinal Products: Management of Adverse Event Reports" has been developed by the
International Cooperation on Harmonization of Technical Requirements for Registration ofVeterinary Medicinal Products (VICH). The Animal and Plant Health Inspection Service
(APHIS) is announcing the availability of th e document and requesting comments.  The
draft guideline deals with the spontaneous reporting system for identification of possible
adverse events following the use of marketed veterinary medicinal products. Because the
draft guideline applies, in part, to veterinary biological products regulated by the Animal
and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting
comments on its provisions so that we may include any relevant public input on the draft inthe Agency's comments to the VICH Steering Committee.
The International Cooperation on Harmonization of Technical Requirements for the
Registration of Veterinary Medicinal Products (VICH) is a unique project conducted under
the auspices of the Office international des épizooties (OIE) that brings together the
regulatory authorities of the European Union, Japan, and the United States andrepresentatives from the animal health industry in the three regions. The purpose of VICH is
to harmonize technical requirements for veteri nary products (both drugs and biologics).
Regulatory authorities and industry experts from Australia and New Zealand participate in
an observer capacity. The World Federation of the Animal Health Industry (the
Confédération Mondiale de L'Industrie de la Santé Animale (COMISA)) provides the
secretarial and administrative support for VICH activities.
6. 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           G/SPS/N/USA/362
Page 2
7. An international standard, guideline or recommendation does not exist [  X ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
8. Relevant documents and language(s) in which these are available:  65 FR 75235,
1 December 2000 (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:  30 January 2001
Agency or authority designated to handle comments: Animal and Plant Health
Inspection Service   [    ] National notification authority, [     ] National enquiry point, or
address, fax number and E-mail address (if available) of other body:  Detailed
instruction on where and how to send comments 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:
United States SPS Enquiry Point/Notification Authority
USDA/FAS/FSTSD
ATTN: Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 10271400 Independence Avenue, S.W.
Washington, D.C. 20250
Phone (202) 720-2239
Fax (202) 690-0677
E-mail Address: ofsts@fas.usda.gov