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

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放大字体  缩小字体 2011-08-14 22:57:19  来源:加拿大司法部  浏览次数:3584
核心提示:本规则主要是针对天然保健食品的生产许可及营业执照、生产要求、设备、包装、标签规定及进出口流通的规定。
发布单位
加拿大司法部
加拿大司法部
发布文号 SOR/2003-196
发布日期 暂无 生效日期 2009-07-01
有效性状态 废止日期 暂无
备注 本规则主要是针对天然保健食品的生产许可及营业执照、生产要求、设备、包装、标签规定及进出口流通的规定。

  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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