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Enabling Statute:
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Natural Health Products Regulations (SOR/2003-196)
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Table of content
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
Manufacturers
Packagers
Labellers
Importers
Distributors
Record Maintenance
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
Good Clinical Practices
Labelling
Records
Submission of Information and Samples
Reaction Reporting
Discontinuance of a Clinical Trial
Suspension and Cancellation
PART 5 GENERAL
Electronic Signatures
Electronic Records
Labelling and Packaging
General
Small Package Labelling
Security Packaging
Pressurized Containers
Cautionary Statements and Child Resistant Packages
Medicinal Ingredient Representations
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
Food and Drug Regulations
Transitional Provisions
Coming into Force
SCHEDULE 1
(Subsection 1(1))
INCLUDED NATURAL HEALTH PRODUCT SUBSTANCES
SCHEDULE 2
(Subsection 1(1))
EXCLUDED NATURAL HEALTH PRODUCT SUBSTANCES
Important Notices