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U.S. Department of Health and Human Services

Animal & Veterinary

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Final VICH Guidance On Impurities Available

July 19, 2000

The Food and Drug Administration (FDA) announced in the July 7, 2000, Federal Register, the availability of two final guidances for industry entitled "Guidance for Industry: Impurities In New Veterinary Drug Substances, VICH GL10 (#92) " and "Guidance for Industry: Impurities In New Veterinary Medicinal Products, VICH GL11 (#93)." These guidance documents were developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

These guidance documents represent current thinking and do not create or confer any rights for or on any person and do not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statute and regulation.

Guidance #92 on impurities in new veterinary drug substances provides guidance for registration applications (referred to as registration applications or marketing authorisation in this final guidance) on the content and qualification of impurities in new veterinary drug substances intended to be used for new veterinary medicinal products, produced by chemical synthesis and not previously registered in the European Union, Japan, and the United States.

Guidance #93 on impurities in new veterinary medicinal products provides guidance recommendations for new animal drug applications (referred to as registration applications or marketing authorisation in this final guidance) on the content and qualification of impurities in new veterinary medicinal products, produced by chemical synthesis and not previously registered in the European Union, Japan, and the United States.

Copies of these documents may be obtained from CVM's Guidelines and Guidances Page or by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755.

Interested persons may submit written comments and suggestions on the guidance documents at any time to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the full title of the guidance document and with the appropriate Docket number -- 99D-2215 (for Guidance #92) or 99D-2145 (for Guidance #93).

Further information about these guidance documents is contained in the July 7, 2000, Federal Register. Information on guidance documents #92 and #93 is also available from Dr. Kevin Greenlees, Center for Veterinary Medicine, (HFV-153), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-827-6977, e-mail: kgreenle@cvm.fda.gov.

Further information on VICH is available from Dr. Sharon R. Thompson (HFV-3), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855, 301-594-1798, e-mail: sthompso@cvm.fda.gov, or from Dr. Robert C. Livingston, Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place (HFV-1), Rockville, MD 20855, 301-594-5903, e-mail: rlivings@cvm.fda.gov.

 

Contact FDA

240-276-9300
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

Communications Staff, HFV-12

7519 Standish Place

Rockville, MD 20855