Using the Antiseptic Teat Solutions Monograph
By: Teri Dickinson, Regulatory Affairs Group Manager, email
Why should you choose to use the Antiseptic Teat Solutions Monograph when looking to register your Teat Dip with the Veterinary Drug Directorate? It’s easy and it saves time. Using the Antiseptic Teat Solutions Monograph to register Teat Dip only takes 4 months for approval instead of 12!
The Antiseptic Teat Solutions monograph has been developed for antiseptic teat solutions that have a well-characterized safety and efficacy profile under specific conditions of use. It describes the requirements necessary to receive market authorization for post-milking antiseptic teat solutions with or without a pre-milking indication, such as teat dips. Note: udder wash solutions and teat/udder wipes will not be considered under this monograph.
The Antiseptic Teat Solutions monograph outlines the permissible conditions of use and labeling requirements such as intended use, directions for use, warnings, medicinal (active) ingredients, emollients and combinations thereof allowing products to be market authorized without the submission of additional evidence.
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