Legislation, Regulations & Guidances (Canada)

Legislation & Regulations

• Patent Act
• Patented Medicines (Notice of Compliance) Regulations
• Food and Drugs Act
• Food and Drug Regulations

Guidances

• Guidance For Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) - (March 5, 2010)
• Data Protection under C.08.004.1 of the Food and Drug Regulations - (March 8, 2010)
• Patented Medicines (Notice of Compliance) Regulations - (March 8, 2010)
• Draft Guidance document: for Sponsors of Subsequent Entry Biologics (SEBs) - (March 27, 2009)
• Draft amendments to Health Canada Guidance re: Patented Medicines (Notice of Compliance) Regulations - (March 27, 2009)
• Draft amendments to Health Canada Guidance re: Data Protection Regulations - (March 27, 2009)