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C.R.C., c. 870 食品和药品条例(Food and Drug Regulations)

   2011-08-24 351
核心提示:  Food and Drug Regulations  A.01.001 - PART A ADMINISTRATION  A.01.001 - General  A.01.010 - Interpretation  

  Food and Drug Regulations

  A.01.001 - PART A ADMINISTRATION

  A.01.001 - General

  A.01.010 - Interpretation

  A.01.020. and A.01.021 - Analysts; Inspectors

  A.01.040 - importations

  A.01.045 - Exports

  A.01.050 - Sampling

  A.01.060 - Tariff of Fees

  A.01.060.1 - Labelling of Food and Drugs in Pressurized Containers

  A.01.065 - Security Packaging

  A.01.066 - Exemptions

  A.01.066 - Application

  A.01.067 - Advertising

  A.01.068 - Sale

  B.01.001 - PART B FOODS

  B.01.001 - Division 1

  B.01.001 - General

  B.01.400 - Interpretation

  B.01.401 - Nutrition Labelling

  B.01.401 - Core Information

  B.01.402 - Additional Information

  B.01.403 - Foods for Children under Two Years of Age

  B.01.404 - Food for Use in Manufacturing other Foods

  B.01.405 - Foods for Enterprise or Institution

  B.01.406 - Basis of Information

  B.01.450 - Presentation of Nutrition Facts Table

  B.01.451 - Location of Nutrition Facts Table

  B.01.452 - Orientation of Nutrition Facts Table

  B.01.453 - Application

  B.01.454 - Standard and Horizontal Formats

  B.01.455 - Simplified Formats

  B.01.456 - Dual Format — Foods Requiring Preparation

  B.01.457 - Aggregate Format — Different Kinds of Foods

  B.01.458 - Dual Format — Different Amounts of Food

  B.01.459 - Aggregate Format — Different Amounts of Food

  B.01.460 - Presentation of Additional Information

  B.01.461 - Standard and Horizontal Formats — Children under Two Years of Age

  B.01.462 - Simplified Formats — Children under Two Years of Age

  B.01.463 - Aggregate Format — Different Kinds of Foods — Children under Two Years of Age

  B.01.464 - Aggregate Format — Different Amounts of Food — Children under Two Years of Age

  B.01.465 - Presentation of Additional Information — Children under Two Years of Age

  B.01.466 - Alternative Methods of Presentation

  B.01.467 - Small Packages

  B.01.500 - Nutrient Content Claims

  B.01.500 - Interpretation

  B.01.501 - Languages

  B.01.502 - Statements or Claims

  B.01.513 - Sensory Characteristic

  B.01.600 - Health Claims

  B.01.600 - Languages

  B.01.601 - Statements or Claims

  B.02.001 - Division 2 Alcoholic Beverages

  B.02.010 - Whisky

  B.02.030 - Rum

  B.02.040 - Gin

  B.02.050 - Brandy

  B.02.070 - Liqueurs and Spirituous Cordials

  B.02.080 - Vodka

  B.02.090 - Tequila

  B.02.091 - Mezcal

  B.02.100 - Wine

  B.02.120 - Cider

  B.02.130 - Beer

  B.03.001 - Division 3 Baking Powder

  B.04.001 - Division 4 Cocoa And Chocolate Products

  B.05.001 - Division 5 Coffee

  B.06.001 - Division 6

  B.06.001 - Food Colours

  B.06.021 - Natural Colours

  B.06.031 - Inorganic Colours

  B.06.041 - Synthetic Colours

  B.07.001 - Division 7 Spices, Dressings And Seasonings

  B.08.001 - Division 8 Dairy Products

  B.08.003 - Milk

  B.08.028.1 - Goat’s Milk

  B.08.030 - Cheese

  B.08.056 - Butter

  B.08.061 - Ice Cream

  B.08.063 - Sherbet

  B.08.071 - Ice Milk

  B.08.075 - Cream

  B.09.001 - Division 9 Fats And Oils

  B.10.003 - Division 10 Flavouring Preparations

  B.11.001 - Division 11 Fruits, Vegetables, Their Products And Substitutes

  B.11.002 - Vegetables

  B.11.101 - Fruits

  B.11.120 - Fruit Juices

  B.11.150 - Fruit Flavoured Drinks

  B.11.201 - Jams

  B.11.220 - Marmalade

  B.11.240 - Jelly

  B.11.250 - Mince Meat

  B.11.260 - Boiled Cider

  B.12.001 - Division 12 Prepackaged Water And Ice

  B.13.001 - Division 13 Grain And Bakery Products

  B.13.021 - Bread

  B.13.051 - Alimentary Paste

  B.13.060 - Breakfast Cereal

  B.14.001 - Division 14 Meat, Its Preparations And Products

  B.14.015 - Meat, Meat By-products

  B.14.030 - Prepared Meats, Prepared Meat By-products

  B.14.061 - Meat Derivatives

  B.14.063 - Meat Stews

  B.14.070 - Meat Specialties

  B.14.072 - Sale of Barbecued, Roasted or Broiled Meat or Meat By-Products

  B.14.073 - Meat Product Extender

  B.14.074 - Extended Meat Products

  B.14.085 - Simulated Meat Products

  B.15.001 - Division 15 Adulteration Of Food

  B.16.001 - Division 16 Food Additives

  B.17.001 - Division 17 Salt

  B.18.001 - Division 18

  B.18.001 - Sweetening Agents

  B.18.025 - Honey

  B.19.001 - Division 19 Vinegar

  B.20.001 - Division 20 Tea

  B.21.001 - Division 21 Marine And Fresh Water Animal Products

  B.21.020 - Prepared Fish

  B.21.031 - Froglegs

  B.22.001 - Division 22 Poultry, Poultry Meat, Their Preparations And Products

  B.22.016 - Poultry Meat Stews

  B.22.020 - Prepared Poultry Meats, Prepared Poultry Meat By-Products

  B.22.027 - Poultry Product Extender

  B.22.028 - Extended Poultry Products

  B.22.029 - Simulated Poultry Products

  B.22.032 - Egg Products

  B.23.001 - Division 23 Food Packaging Materials

  B.24.001 - Division 24

  B.24.001 - Foods for Special Dietary Use

  B.24.100 - Formulated Liquid Diets

  B.24.200 - Meal Replacements, Nutritional Supplements, Prepackaged Meals and Foods Sold by Weight Reduction Clinics

  B.24.300 - Foods Represented for Use in Very Low Energy Diets

  B.25.001 - Division 25

  B.25.001 - Interpretation

  B.25.002 - Infant Foods

  B.25.045 - Human Milk Substitutes and Food Containing Human Milk Substitutes

  B.26.001 - Division 26 Food Irradiation

  B.26.001 - Interpretation

  B.26.002 - Application

  B.26.003 - General

  B.26.004 -  Records

  B.26.005 - Changes to the Table

  B.27.001 - Division 27 Low-Acid Foods Packaged In Hermetically Sealed Containers

  B.28.001 - Division 28 Novel Foods

  B.28.001 - Interpretation

  B.28.002 - Pre-market notification

  C.01.001 - PART C DRUGS

  C.01.001 - Division 1

  C.01.001 - General

  C.01.014 - Assignment and Cancellation of Drug Identification Numbers

  C.01.015 - Tablet Disintegration Times

  C.01.016 - Prohibition

  C.01.017 - Serious Adverse Drug Reaction Reporting

  C.01.018 - Annual Summary Report and Case Reports

  C.01.019 - Issue-related Summary Report

  C.01.020 - Maintenance of Records

  C.01.021 - Limits of Drug Dosage

  C.01.028 - Cautionary Statements and Child Resistant Packages

  C.01.036 - Miscellaneous

  C.01.040.2 - Colouring Agents

  C.01.041 - Schedule F Drugs

  C.01.051 - Recalls

  C.01.061 - Limits of Variability

  C.01.071 - Mercuric Chloride Tablets

  C.01.101 - Synthetic Sweeteners

  C.01.131 - Aminopyrine and Dipyrone

  C.01.134 - Coated Potassium Salts

  C.01.401 - Antibiotics

  C.01.430. to C.01.432 - Chloramphenicol

  C.01.600 - Veterinary Drugs

  C.01.625 - Contraceptive Drugs

  C.01A.001 - Division 1A Establishment Licences

  C.01A.001 - Interpretation

  C.01A.002 - Application

  C.01A.004 - Prohibition

  C.01A.005 - Application

  C.01A.008 - Issuance

  C.01A.009 - Annual Licence Review

  C.01A.010 - Refusal to Issue

  C.01A.011 - Terms and Conditions

  C.01A.013 - Notification

  C.01A.016 - Suspension

  C.01A.018.1 - Cancellation

  C.01A.019 - Designation

  C.02.001 - Division 2 Good Manufacturing Practices

  C.02.003 - Sale

  C.02.004 - Premises

  C.02.005 - Equipment

  C.02.006 - Personnel

  C.02.007 - Sanitation

  C.02.009 - Raw Material Testing

  C.02.011 - Manufacturing Control

  C.02.013 - Quality Control Department

  C.02.016 - Packaging Material Testing

  C.02.018 - Finished Product Testing

  C.02.020 - Records

  C.02.025 - Samples

  C.02.027 - Stability

  C.02.029 - Sterile Products

  C.02.030 - Medical Gases

  C.03.001 - Division 3

  C.03.001 - Schedule C Drugs

  C.03.201 - Radiopharmaceuticals

  C.03.205 - Drugs, other than Radionuclides, Sold or Represented for Use in the Preparation of Radiopharmaceuticals

  C.04.001 - Division 4

  C.04.001 - Schedule D Drugs

  C.04.050 - Bacterial Vaccines, Products Analogous to Bacterial Vaccines

  C.04.060 - Typhoid Vaccine

  C.04.065 - Pertussis Vaccine

  C.04.070 - B.C.G. (Bacille Calmette-Guerin) Vaccine

  C.04.090 - Products Analogous to Bacterial Vaccines

  C.04.100 - Virus and Rickettsial Vaccines

  C.04.110 - Smallpox Vaccine

  C.04.122 - Poliomyelitis Vaccine

  C.04.128 - Poliovirus Vaccine, Live, Oral

  C.04.137 - Bacteriophage

  C.04.140 - Toxins, Toxoids

  C.04.140 - Schick Test Reagents

  C.04.160 - Diphtheria Toxoid

  C.04.180 - Tetanus Toxoid

  C.04.210 - Antitoxins, Antisera

  C.04.230 - Preparations from Human Sources

  C.04.400 - Human Plasma Collected by Plasmapheresis

  C.04.400 - Interpretation

  C.04.401 - Prohibitions

  C.04.402 - Fabricator’s Responsibility

  C.04.403 - Consent and Preliminary evaluation

  C.04.405 - Specific Immunization

  C.04.406 - evaluation Before Collection

  C.04.407 - Plasma Protein Composition

  C.04.408 - ongoing Review of Collection Records

  C.04.409 - Plasmapheresis Procedures

  C.04.410 - Maximum Volumes and Minimum Intervals

  C.04.411 - Anticoagulant Solution

  C.04.412 - Samples for Testing

  C.04.414 - Preservatives and Additives

  C.04.415 - Containers

  C.04.416 - Labelling

  C.04.417 - Storage

  C.04.419 - Records

  C.04.421 - Information to the Minister

  C.04.550 - Insulin Preparations

  C.04.553 - Insulin Injection or Insulin

  C.04.557 - Insulin Zinc Suspension — Rapid

  C.04.563 - Insulin Zinc Suspension — Medium

  C.04.569 - Insulin Zinc Suspension — Prolonged

  C.04.575 - Globin Insulin with Zinc

  C.04.582 - NPH Insulin or Isophane Insulin

  C.04.590 - Protamine Zinc Insulin

  C.04.597 - Sulphated Insulin

  C.04.650 - Labelling of Insulin Preparations

  C.04.675 - Anterior Pituitary Extracts

  C.05.001 - Division 5 Drugs For Clinical Trials Involving Human Subjects

  C.05.001 - Interpretation

  C.05.002 - Application

  C.05.003 - Prohibition

  C.05.004 - General

  C.05.005 - Application for Authorization

  C.05.006 - Authorization

  C.05.007 - Notification

  C.05.008 - Amendment

  C.05.009 - Additional Information and Samples

  C.05.010 - Sponsor’s Obligations

  C.05.010 - Good Clinical Practices

  C.05.011 - Labelling

  C.05.012 - Records

  C.05.013 - Submission of Information and Samples

  C.05.014 - Serious Unexpected Adverse Drug Reaction Reporting

  C.05.015 - Discontinuance of a Clinical Trial

  C.05.016 - Suspension and Cancellation

  Division 6

  C.06.001 - General

  C.06.002 - Conjugated Estrogens

  C.06.003 - Conjugated Estrogens for Injection

  C.06.004 - Conjugated Estrogens Tablets

  C.06.120 - Digitoxin

  C.06.121 - Digitoxin Tablets

  C.06.130 - Digoxin

  C.06.131 - Digoxin Elixir

  C.06.132 - Digoxin Injection

  C.06.133 - Digoxin Tablets

  C.06.161 - Esterified Estrogens

  C.06.162 - Esterified Estrogens Tablets

  C.06.170 - Gelatin

  C.06.250 - Thyroid

  C.07.001 - Division 7 Sale of Drugs for the Purposes of Implementing the General Council Decision

  C.07.001 - Interpretation

  C.07.002 - Application

  C.07.003 - Application for Authorization

  C.07.004 - Authorization

  C.07.007 - Notice to Commissioner of Patents

  C.07.008 - Marking and Labelling

  C.07.010 - Records

  C.07.011 - Notice to Minister

  C.08.001 - Division 8

  C.08.001 - New Drugs

  C.08.010 - Sale of New Drug for Emergency Treatment

  C.08.012 - Sale of Medicated Feeds

  C.08.013 - Experimental Studies

  C.08.013 - Conditions of Sale

  C.08.014 - Experimental Studies Certificate

  C.08.016 - Labelling

  C.08.017 - Conditions of Experimental Study

  C.08.018 - Suspension or Cancellation of Experimental Studies Certificate

  C.09.001 - Division 9

  C.09.001 - Non-prescription Drugs

  C.09.010 - Analgesics

  C.09.010 - General

  C.09.020 - Acetaminophen

  C.09.030 - Salicylates

  D.01.001 - Division 10 [Repealed, SOR/98-423, s. 9]

  D.01.001 - PART D VITAMINS, MINERALS AND AMINO ACIDS

  D.01.002 - Division 1 Vitamins In Foods

  D.02.001 - Division 2 Mineral Nutrients In Foods

  D.03.001 - Division 3 Addition Of Vitamins, Mineral Nutrients Or Amino Acids To Foods

  D.05.001. to D.05.007 - Division 4 [Repealed, SOR/2003-196, s. 105]

  D.05.001. to D.05.007 - Division 5 Minerals In Drugs

  E.01.001 - PART E CYCLAMATE AND SACCHARIN SWEETENERS

  E.01.002 - Sale

  E.01.003 - Advertising

  E.01.004 - Labelling

  G.01.001 - PART G ConTROLLED DRUGS

  G.01.001 - Division 1

  G.01.001 - General

  G.01.010 - Prescribed Manner of Notice of Application for an Order of Restoration

  G.02.001 - Division 2 Licences And Licensed Dealers

  G.03.001 - Division 3 Pharmacists

  G.04.001 - Division 4 Practitioners

  G.05.001 - Division 5 Hospitals

  G.06.001 - Division 6

  G.06.001 - Authority and Penalty

  G.06.002.1 - Test Kits Containing Controlled Drugs

  G.07.001 - Division 7

  G.07.001 - General

  SCHEDULE

  J.01.001 - PART J RESTRICTED DRUGS

  J.01.001 - Division 1

  J.01.001 - General

  J.01.002 - Possession

  J.01.003 - Licences, Permits and Licensed Dealers

  J.01.015 - Sale of a Restricted Drug

  J.01.021 - Records and Inspection

  J.01.030 - Packaging and Labelling

  J.01.033.1 - Test Kits Containing Restricted Drugs

  J.01.035 - Prescribed Manner of Notice of Application for an Order of Restoration

  SCHEDULE

  SCHEDULE F

  SCHEDULE K - REASonABLE DAILY INTAKE FOR VARIOUS FOODS

  SCHEDULE L - NUTRITION FACTS TABLE FORMATS

  SCHEDULE M - REFERENCE AMOUNTS

       详细内容请详见    C.R.C.,_c._870.pdf

   



 
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