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96-3430
29/08/1996
30/08/1996
02/09/1996
United States of America
États-Unis d'Amérique
Estados Unidos de América
Department of Agriculture, Animal and Plant Health Inspection Service (65)
Version Products covered Interpreted
HS3 3004 - Medicaments consisting of mixed or unmixed products for therapeutic or prophylactic uses, put up in measured doses "incl. those in the form of transdermal administration" or in forms or packings for retail sale (excl. goods of heading 3002, 3005 or 3006) No
Products covered Interpreted
There are currently no items in the database.
Veterinary biological products
Produits biologiques à usage vétérinaire
Productos biológicos veterinarios
 
 
Viruses, serums, toxins, and analogous products; definition of biological products and guidelines (4 pages)
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The Animal and Plant Health Inspection Service (APHIS) is proposing to amend the regulations by revising the definition of "biological products". The amendment is necessary in order to reflect current usage and advances in scientific knowledge, and to clarify certain parts of the definition. APHIS is also proposing to add a definition of "guidelines" to the regulations. Guidelines are used to assist manufacturers of veterinary biologics and other interested persons regarding test procedures, methods, and other considerations that would be acceptable to the agency in support of licensure of a veterinary biological product.





This action would clarify definitions and the purpose and intent of guidelines.

Is there a relevant international standard? If so identify the standard:

 
 
 
 
 
An international standard, guideline or recommendation does not exist.
61 FR 43483, 23 August 1996; 9 CFR Part 101
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Date of adoption to be determined; effective date of entry into force to be determined upon publication of the final rule in the Federal Register.

Proposed date of entry into force

 
Date of adoption to be determined; effective date of entry into force to be determined upon publication of the final rule in the Federal Register.

Effect of measure on trade

 

Final date for comments

 

Agency responsible

 
 
 
 
 
To view Members' latest Enquiry Point and Notification Authority contact details as provided to the WTO Secretariat Click here
Date of adoption to be determined; effective date of entry into force to be determined upon publication of the final rule in the Federal Register.

Text available from

 
 
 
 
 
To view Members' latest Enquiry Point and Notification Authority contact details as provided to the WTO Secretariat Click here
Date of adoption to be determined; effective date of entry into force to be determined upon publication of the final rule in the Federal Register.
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