Health Canada

The Veterinary Drugs Directorate has compiled ten years of data on the use of injectable tiletamine-zolazepam products for immobilizing wildlife in Canada. There are no approved tiletamine-zolazepam products in Canada. Access to a foreign authorized tiletamine-zolazepam product is permitted...

In agreeing to apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has...

This guidance helps to classify safety and efficacy changes made to new drugs that have received a Notice of Compliance (NOC) pursuant to section C.08.004 of the Food and Drug Regulations (the Regulations).

This section highlights the range in categories of data and contextual information that may be relevant to the evaluation of a particular submission.

This section of the guidance provides criteria and examples to help you classify a safety or efficacy related change. Examples are not exhaustive and are meant to provide guidance on types of acceptable changes.

To ensure the safety of food produced in Canada from animals, Health Canada's Veterinary Drugs Directorate (VDD) is responsible for a comprehensive scientific review of veterinary drugs before they are approved for sale in this country. Veterinary drugs are used, not only to combat disease in...

The NOC is issued to a manufacturer following the satisfactory review of a submission for a new drug, and signifies compliance with the Food and Drug Regulations. The database is updated nightly and contains NOC information on human drugs from January 1, 1994 to date. It also contains NOC...

Health Canada’s Veterinary Drugs Directorate (VDD) is clarifying the expectations for the information about Good Manufacturing Practices (GMP) status that should accompany veterinary drug submissions.

The purpose of this guidance document is to present guidelines and criteria for classification in order to clarify the differences between drugs and feeds, and to assist in determining the appropriate regulatory oversight for a product destined for use in livestock species. The pursued objectives...