In March 2025, Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act. The Guide sets out the principles, policies, considerations and standards that Health Canada should follow in situations where it may be appropriate for the Minister of Health to make an order pursuant to the new ministerial authorities granted by the Bill C-69 (Budget Implementation Act) amendments to the Food and Drugs Act.
The new ministerial authorities fall into three categories:
- Supplementary rules authority
- Exemption authority
- Decision of foreign regulatory authority (reliance authority)
These new authorities are intended to be adaptable tools broadly applicable for various purposes, including, for example, maintaining product availability if there is a shortage, removing barriers that create areas of unmet need, or addressing emerging health or safety issues or priorities.
The Guide provides information on the new ministerial authorities, including the legislative requirements that must be met for the Minister to use the authorities, to what or whom the authorities apply, and supports the development of procedures and orders related to these authorities.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.