What Canada Food and Drugs Act 1985 requires
The Food and Drugs Act (R.S.C. 1985, c. F-27), consolidated and continuously amended, prohibits the sale of a food that is adulterated, unfit for human consumption, or misleadingly labelled under Section 4, requires a New Drug Submission or Abbreviated New Drug Submission approved by Health Canada under Sections 30(1) and 55 before a new human or veterinary pharmaceutical drug may be sold in Canada, mandates that medical devices meet the applicable class-specific safety and effectiveness requirements under the Medical Devices Regulations (SOR/98-282) before sale, requires natural health products to hold a product licence issued by Health Canada under the Natural Health Products Regulations (SOR/2003-196), and imposes penalties of up to CAD 5 million and 2 years imprisonment for serious violations of the Act, making it the primary pre-market approval and post-market surveillance framework for drugs, food, medical devices, and natural health products in Canada.
Pillar: Pharmaceuticals & Life Sciences · Authority: Parliament of Canada · Version: 1.0.0 · Last updated:
Primary source: https://laws-lois.justice.gc.ca/eng/acts/F-27/
SHA-256 integrity: 29fd938c76aa7ffa297280ad939e2b7ded80b77c874e92083d2a21f459e934a7
Primary Citations — 5 traced to source
- {"title":"Food and Drugs Act (R.S.C. 1985, c. F-27)","url":"https://laws-lois.justice.gc.ca/eng/acts/F-27/","section":"Sections 2 (definitions), 4-8 (food prohibitions), 21.31-21.32 (licence suspension), 23-24 (inspection powers), 30 (regulations for drugs), 31 (penalties), Schedule A (diseases for which drugs cannot be advertised)","relevance":"Primary Canadian federal legislation governing food safety, drug and device pre-market authorization, and natural health product licensing; prohibits sale of adulterated food, requires Health Canada Notice of Compliance for new drugs, mandates Good Manufacturing Practice compliance, and imposes penalties up to CAD 5 million for serious violations"}
- {"title":"Food and Drug Regulations (C.R.C., c. 870)","url":"https://laws-lois.justice.gc.ca/eng/regulations/C.R.C.,_c._870/","section":"Division 1 (food adulteration and labelling), Divisions 2-27 (food compositional standards), Part C Division 2 (GMP for drugs), Part C Division 5 (clinical trials), Part C Division 8 (new drug submissions, notices of compliance)","relevance":"Comprehensive subsidiary regulations under the Food and Drugs Act; Part C Division 8 governs New Drug Submission content and review timelines; Division 5 governs clinical trial authorization; Division 2 GMP requirements apply to all Canadian drug manufacturing sites"}
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