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Enabling Statute: Food and Drugs Act
Natural Health Products Regulations (SOR/2003-196)
Disclaimer: These documents are not the official versions (more).
Regulation current to October 23rd, 2007
Attention: See coming into force provision and notes, where applicable.
 
Table of contents
  1. Natural Health Products Regulations
    1. INTERPRETATION
    2. APPLICATION
    3. PART 1 : PRODUCT LICENCES
      1. Prohibition
      2. Licence Application
      3. Sixty-Day Disposition
      4. Issuance and Amendment
      5. Product Number
      6. Refusal to Issue or Amend
      7. Amendment
      8. Notification
      9. Fundamental Change
      10. Licence Contents
      11. Additional Information or Samples
      12. Safety Information
      13. Direction to Stop Sale
      14. Suspension and Cancellation
      15. Site Information
      16. Records
      17. Reaction Reporting
      18. Recall Reporting
    5. PART 2 : SITE LICENCES
      1. Application
      2. Prohibition
      3. Licence Application
      4. Issuance and Amendment
      5. Refusal to Issue or Amend
      6. Amendment
      7. Notification
      8. Licence Contents
      9. Expiry
      10. Renewal
      11. Additional Information
      12. Relinquishment of Authorization
      13. Suspension and Cancellation
    7. PART 3 : GOOD MANUFACTURING PRACTICES
      1. Prohibition
      2. Specifications
      3. Premises
      4. Equipment
      5. Personnel
      6. Sanitation Program
      7. Operations
      8. Quality Assurance
      9. Stability
      10. Records
      11. Sterile Natural Health Products
      12. Ophthalmic Use
      13. Lot or Batch Samples
      14. Recall Reporting
    9. PART 4 : CLINICAL TRIALS INVOLVING HUMAN SUBJECTS
      1. Interpretation
      2. Application
      3. Prohibition
      4. Application for Authorization
      5. Authorization
      6. Commencement Notice
      7. Notification
      8. Amendment
      9. Additional Information and Samples
      10. Sponsor's Obligations
      11. Suspension and Cancellation
    11. PART 5 : GENERAL
      1. Electronic Signatures
      2. Electronic Records
      3. Labelling and Packaging
      4. Inspectors
      5. Imported Natural Health Products
      6. Export Certificates
      7. Sampling of Articles
      8. Tablet Disintegration Times
      9. Sale of Natural Health Product for Emergency Treatment
    13. PART 6 : AMENDMENTS, TRANSITIONAL PROVISIONS AND COMING INTO FORCE
      1. Amendments
      2. Transitional Provisions
      3. Coming into Force
    15. SCHEDULE 1 : INCLUDED NATURAL HEALTH PRODUCT SUBSTANCES
    16. SCHEDULE 2 : EXCLUDED NATURAL HEALTH PRODUCT SUBSTANCES

Last updated: 2007-11-16
Last updated: 2007-11-16
Last updated: 2007-11-16
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