Publication of the guidance on data protection under C.08.004.1 of the Food and Drug Regulations: Notice

June 16, 2025
Our reference number: 25-101572-962

Health Canada is pleased to announce an update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations.

The Office of Patented Medicines and Liaison (OPML), within the Office of Submissions and Intellectual Property, administers the data protection scheme under section C.08.004.1 of the Food and Drug Regulations.

The Guidance Document has been amended to align with existing Health Products and Food Branch policies and to record the OPML's ongoing practices as they relate to the administration of the data protection scheme.

Questions or concerns related to this Guidance Document should be directed to the OPML at: opml-bmbl@hc-sc.gc.ca