SOR/2003-196 加拿大天然保健品条例(Natural Health Products Regulations)

　　Natural Health Products Regulations

　　1 - INTERPRETATION

　　2 - APPLICATION

　　4 - PART 1 PRODUCT LICENCES

　　4 - Prohibition

　　5 - Licence Application

　　6 - Sixty-Day Disposition

　　7 - Issuance and Amendment

　　8 - Product Number

　　9 - Refusal to Issue or Amend

　　11 - Amendment

　　12 - Notification

　　13 - Fundamental Change

　　14 - Licence Contents

　　15 - Additional Information or Samples

　　16 - Safety Information

　　17 - Direction to Stop Sale

　　18 - Suspension and Cancellation

　　22 - Site Information

　　23 - Records

　　24 - Reaction Reporting

　　25 - Recall Reporting

　　26 - PART 2 SITE LICENCES

　　26 - Application

　　27 - Prohibition

　　28 - Licence Application

　　29 - Issuance and Amendment

　　30 - Refusal to Issue or Amend

　　32 - Amendment

　　33 - Notification

　　34 - Licence Contents

　　35 - Expiry

　　36 - Renewal

　　37 - Additional Information

　　38 - Relinquishment of Authorization

　　39 - Suspension and Cancellation

　　43 - PART 3 GOOD MANUFACTURING PRACTICES

　　43 - Prohibition

　　44 - Specifications

　　45 - Premises

　　46 - Equipment

　　47 - Personnel

　　48 - Sanitation Program

　　49 - Operations

　　51 - Quality Assurance

　　52 - Stability

　　53 - Records

　　53 - Manufacturers

　　54 - Packagers

　　55 - Labellers

　　56 - Importers

　　57 - Distributors

　　58 - Record Maintenance

　　59 - Sterile Natural Health Products

　　60 - Ophthalmic Use

　　61 - Lot or Batch Samples

　　62 - Recall Reporting

　　63 - PART 4 CLINICAL TRIALS INVOLVING HUMAN SUBJECTS

　　63 - Interpretation

　　64 - Application

　　65 - Prohibition

　　66 - Application for Authorization

　　67 - Authorization

　　69 - Commencement Notice

　　70 - Notification

　　71 - Amendment

　　73 - Additional Information and Samples

　　74 - Sponsor's Obligations

　　74 - Good Clinical Practices

　　75 - Labelling

　　76 - Records

　　77 - Submission of Information and Samples

　　78 - Reaction Reporting

　　79 - Discontinuance of a Clinical Trial

　　80 - Suspension and Cancellation

　　84 - PART 5 GENERAL

　　84 - Electronic Signatures

　　85 - Electronic Records

　　86 - Labelling and Packaging

　　86 - General

　　94 - Small Package Labelling

　　95 - Security Packaging

　　96 - Pressurized Containers

　　97 - Cautionary Statements and Child Resistant Packages

　　98 - Medicinal Ingredient Representations

　　99 - Inspectors

　　100 - Imported Natural Health Products

　　101 - Export Certificates

　　102 - Sampling of Articles

　　103 - Tablet Disintegration Times

　　103.1 - Sale of Natural Health Product for Emergency Treatment

　　103.2 - Exemptions

　　103.2 - Advertising

　　103.3 - Sale

　　104 - PART 6 AMENDMENTS, TRANSITIONAL PROVISIONS AND COMING INTO FORCE

　　104 - Amendments

　　104 - Food and Drug Regulations

　　108 - Transitional Provisions

　　116 - Coming into Force

　　SCHEDULE 1 - INCLUDED NATURAL HEALTH PRODUCT SUBSTANCES

　　SCHEDULE 2 - EXCLUDED NATURAL HEALTH PRODUCT SUBSTANCES

      具体内容请详见  天然保健品条例.pdf