Does a veterinary drug/medical device combination require an AIF-NDS?
Yes, you are required to submit an AIF-NDS for the drug product ingredient in your veterinary medical device. Will any additional studies be requested of me? VDD will request additional information if deemed necessary. How should the VDD be notified of changes in ingredient sources? If the change is from a non-animal to an animal source, notification of this change must be given to the VDD within 30 days by completing Section 3, 4, 5 and 6 of the AIF-NDS. The revised section should be sent to the address noted at the end of this document. What is Health Canada’s legal authority to seek information on animal-sourced ingredients? The manufacturer/sponsor shall have information regarding the composition of ingredients used in drug products. In accordance with the Food and Drugs Act and Regulations , Division 8 (New Drugs), C.08.002(2), the new drug submission must contain information pertaining to all ingredients and the “specifications for each of those ingredients” (c), the entire manuf
