CARM: What all importers need to know about CARM

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HEALTH CANADA (HC)

Health Canada regulations under the Single Window Initiative

Health Canada is responsible for national public health in Canada covering a wide array of commodities.

The twelve programs that fall under Health Canada:

  • Consumer Product Safety
    • Information on incident reporting, recalls and alerts, cosmetic information, product safety education and consumer product requirements.
  • Human Drugs
    • The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety.
  • Natural Health Products
    • Mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs)
  • Importation of Controlled Substances and Precursors
    • Administer legislation and activities related to controlled drugs and substances
  • Veterinary Drugs
    • evaluates and monitors the safety, quality and effectiveness, sets standards and promotes the prudent use of veterinary drugs administered to food-producing and companion animals.
  • Radiation Emitting Devices
    • Types of radiation and how they are monitored and measured.
  • Blood and Blood Components
    • inspections of all blood establishments regulated under the Blood Regulations.
  • Cells, Tissues and Organs
    • safety requirements with respect to processing; storage; record keeping; distribution; importation; error, accident and adverse reaction investigation and reporting.
  • Active Pharmaceutical Ingredients
    • Good manufacturing practices
  • Donor Semen
    • In Canada, donor semen for assisted conception is classified as a drug. It is regulated under the Food and Drugs Act and the Semen Regulations.
  • Medical Devices
    • covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition.
  • Pesticides
    • All pesticides used in Canada must meet the requirements of the Pest Control Products Act and its regulations.

Intended use and Program conditions

Conditions may apply to determine if data needs to be submitted to Health Canada for each of the above programs.

For information about the data element rationales for each Program, visit:
https://www.cbsa-asfc.gc.ca/prog/sw-gu/data/hc-sc-eng.html#s1.

For Data Element Matching Criteria Tables complete with HS Tariff Classification cross-reference please refer to
Health Canada (HC).

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