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
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