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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
).
Full Document for Printing [221Kb]
Regulation current to October 23rd, 2007
Attention: See coming into force provision and notes, where applicable.
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Table of contents
Natural Health Products Regulations
INTERPRETATION
APPLICATION
PART 1 :
PRODUCT LICENCES
Prohibition
Licence Application
Sixty-Day Disposition
Issuance and Amendment
Product Number
Refusal to Issue or Amend
Amendment
Notification
Fundamental Change
Licence Contents
Additional Information or Samples
Safety Information
Direction to Stop Sale
Suspension and Cancellation
Site Information
Records
Reaction Reporting
Recall Reporting
PART 2 :
SITE LICENCES
Application
Prohibition
Licence Application
Issuance and Amendment
Refusal to Issue or Amend
Amendment
Notification
Licence Contents
Expiry
Renewal
Additional Information
Relinquishment of Authorization
Suspension and Cancellation
PART 3 :
GOOD MANUFACTURING PRACTICES
Prohibition
Specifications
Premises
Equipment
Personnel
Sanitation Program
Operations
Quality Assurance
Stability
Records
Sterile Natural Health Products
Ophthalmic Use
Lot or Batch Samples
Recall Reporting
PART 4 :
CLINICAL TRIALS INVOLVING HUMAN SUBJECTS
Interpretation
Application
Prohibition
Application for Authorization
Authorization
Commencement Notice
Notification
Amendment
Additional Information and Samples
Sponsor's Obligations
Suspension and Cancellation
PART 5 :
GENERAL
Electronic Signatures
Electronic Records
Labelling and Packaging
Inspectors
Imported Natural Health Products
Export Certificates
Sampling of Articles
Tablet Disintegration Times
Sale of Natural Health Product for Emergency Treatment
PART 6 :
AMENDMENTS, TRANSITIONAL PROVISIONS AND COMING INTO FORCE
Amendments
Transitional Provisions
Coming into Force
SCHEDULE 1 : INCLUDED NATURAL HEALTH PRODUCT SUBSTANCES
SCHEDULE 2 : EXCLUDED NATURAL HEALTH PRODUCT SUBSTANCES
Important Notices
Important Notices
Important Notices