Therapeutic Products

Act: Food and Drugs Act, R.S.C. 1985, c. F-27
Regulation: Food and Drug Regulations, C.R.C. Vol. VIII, c. 870, p. 5963

To Whom Does This Apply?

Manufacturers, producers, advertisers, distributors, exporters and importers of drugs, and other therapeutic products.

Summary

A "drug" is defined in the Food and Drugs Act to include "any substance or mixture of substances manufactured, sold or represented for use in:

• the diagnosis, treatment, mitigation or prevention of disease, disorder or abnormal physical state, or the symptoms thereof, in human or animal;
• restoring, correcting, or modifying organic functions in human or animal; or
• disinfection in premises in which food is manufactured, prepared or kept.

TheFood and Drugs Act and Regulations set requirements for the production and sale of food and drug products. The Act governs the manufacturing, producing, marketing, labelling, importing and exporting of foods and drugs. The Act contains provisions for inspection and enforcement, and contravention of the Act can result in fines and imprisonment.

TheFood and Drugs Act covers a broad range of products:

• Pharmaceuticals - prescription, non-prescription or over-the-counter;
• Biologicals - vaccines, blood and blood products, certain hormones and enzymes, allergenic extracts, tissues and organs, biotherapeutics, e.g. recomb, DNA products, genetic engineering, etc.;
• Radiopharmaceuticals;
• Medical Devices - medical and dental implants, medical equipment and instruments, test kits for diagnosis, contraceptive devices;
• Disinfectants;
• Low-risk products, e.g. sunscreens, antiperspirants, toothpaste, etc.;
• Cosmetics; and
• Narcotic, controlled and restricted substances.

Under the Food and Drugs Act, if a manufacturer wants to sell a drug, a Drug Identification Number (DIN) is required. If a product defined as a drug under theFood and Drugs Act was sold without a DIN, it was not in compliance with Canadian law. The DIN is a numbers located on the label of any drug product that has been approved for sale. It indicates that a product has undergone -and passed- a review of its formulation, labelling, and instructions for use. The DIN is issued by Health Canada. Please refer to the national contact listed below.

Under theFood and Drugs Act, an establishment licence is required for all businesses engaged in any of the six activities related to the manufacturing and testing of all drugs in dosage or bulk intermediates of Schedule C (radiopharmaceutical) and D (biological) drugs.

The six activities are:

• fabrication;
• packaging/labelling;
• importing;
• distribution;
• wholesale; and
• operation of a testing laboratory.

Definitions of these activities can be found in the Food and Drug Regulations - Amendment (SOR/97-12, Schedule No. 624) Establishment Licence Framework or the guidance documents on establishment licensing. The first can be downloaded from the Justice Canada Web site. The guidance documents and the establishment licence application forms can be downloaded from the Health Canada's Web site at the Drugs and Health Products/Compliance and Enforcement page.

Additional Information

Note: For more information on regulations for the following products, please see the documents:

• Medical Devices;
• Cosmetics;
• Narcotics and Controlled Drugs; and
• Natural Health Products Regulations. 

DISCLAIMER
Information contained in this section is of a general nature only and is not intended to constitute advice for any specific fact situation. For particular questions, the users are invited to contact their lawyer. For additional information, see contact(s) listed below.

Quebec Contact(s):
See National Contact.

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National Contact(s):
Submission and Information Policy Division
Therapeutic Products Directorate,
Health Products and Food Branch
Health Canada
A.L. 0201A1, Finance Building, Tunney's Pasture
Ottawa, Ontario  K1A 1B6
Telephone: (613) 946-6431
Fax: 613-941-5366
Toll-free (information): 1-866-225-0709
TTY Toll-free (hearing impaired): 1-800-267-1245
E-mail: sipd-submissions@hc-sc.gc.ca
Web site: http://www.hc-sc.gc.ca/index_e.html