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AusCann Group Holdings Limited Commences Australian Product Registration for Dogs

07/19/2021 | 06:57pm
AusCann Group Holdings Limited announce that it has submitted its first module to the Australian Pesticides and Veterinary Medicines Association (APVMA) to commence the submission of its dossier for the registration of DermaCann®, in development for anti-inflammatory and immune support in dogs with dermatological conditions. The Toxicology module was submitted following a positive response to a Pre-Application Assistance (PAA) request with the APVMA, outlining a project plan with agreed milestones for a time-shift application which allows for the staged submission of supporting data packages for longer module assessments (such as Toxicology) while other supporting data packages are being prepared for submission. Subject to approval, DermaCann® will become a world `first in class' regulatory approved oral cannabinoid-based veterinary product for skin health in dogs, and the first and only APVMA-approved medicine containing cannabinoids to be supplied via prescription through Australian veterinarians. The Safety and Toxicological evaluation of DermaCann® was led by Dr. Margaret Curtis, Head of Research and Development for AusCann, and Dr. Jeffery Sherman, a Board-certified toxicologist who commenced consulting on the dossier in 2018. It includes almost 2,000 pages of supporting data and literature and is the result of over 3 years of research and dossier preparation including 8 independent in-vitro and in- vivo toxicology GLP (Good Laboratory Practises) studies completed across Hungary, Germany and the United States. The global canine skin and dermatitis market is worth an estimated US$1.5B globally, and the approval of DermaCann® will provide veterinarians with a safe and clinically validated, cannabinoid-based veterinary product to be used as a beneficial therapy in a canine atopic dermatitis management regimen. The unique property of DermaCann® is an exclusive combination of plant-based ingredients, including high-purity cannabidiol (CBD), to help strengthen the natural immune and inflammatory responses in dogs through activation of the endocannabinoid system.
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