In Canada, you must have:

• A quality control/quality assurance department
• Batch documentation and certificates of analysis for each lot or batch sent to Canada
• A set of standard operating procedures (SOPs) to manage the product importing under Canadian GMP requirements
• Regular product testing and lot release (disposition)

	Exporting a Drug to Canada

Drug products include prescription and non-prescription pharmaceuticals, disinfectants, and sanitizers with disinfectant claims.

You need a DIN (Drug Identification Number) for drugs sold in Canada. There are specific Good Manufacturing Practices (GMPs) for drug products, regulated by Health Canada’s Health Products and Food Branch Inspectorate (HPFBI).

What are the specific requirements for importing drug products to Canada?

If you are importing drug products to Canada from the United States, you must have: A drug Establishment Licence (EL) A quality control department in Canada A copy of Health Canada’s market authorization for the product The Master Production document for the drug

Batch documentation and certificates of analysis for each lot or batch imported A copy of the most recent FDA inspection report pertaining to the manufacturer Stability data for the drug including the ongoing stability protocol A set of standard operating procedures (SOPs) to manage the drug importation under the GMP requirements

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Failure to comply with these requirements may result in penalties such as
product recalls, EL suspension, product seizure, cross-border shipment refusals
at Customs, or public notices about product problems...

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...avoid these upfront by employing Q&C®. We guarantee you will meet Health Canada regulations in order to keep your product moving
across the border.

For more details about this process, refer to Q&C®’s Exporting A Drug Product or Dietary Supplement to Canada flowchart (PDF). For more information, contact
Graham Mills at 1-877-877-5152 x210.

	Exporting a Dietary Supplement or Natural Health Product

Dietary Supplements and Natural Health Products are classified as: Vitamins and minerals Herbal remedies Homeopathic medicines Traditional medicines such as traditional Chinese medicines Probiotics Other products like amino acids and essential fatty acids

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Dietary Supplementss must be safe for consideration as over-the-counter products, be available for self-care and self-selection and not require a prescription to be sold.

You need an NPN (Natural Product Number) for natural health products in Canada. There are separate Good Manufacturing Practices (GMPs) for drug products and Dietary Supplements. Dietary Supplements are regulated by Health Canada’s Natural Health Products Directorate (NHPD).

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Regulatory inspections by Health Canada’s Health Products and Food Branch Inspectorate (HPFBI) inspectors, trained in NHP Regulations, commenced January 1, 2006.

Compliance efforts will target natural health products that: Pose an unacceptable risk to health Do not have a valid DIN, NPN (natural product number) or DIN-HM (DIN-homeopathic) Have not been issued a submission number by the NHPD

These regulations are relatively new. If you have a drug product with a drug identification number (DIN) that may be an NHP, we can help you transition the product to an NPN.

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As per the NHP GMPs:

• You need an NPN (Natural Product Number) for natural health products in Canada. There are separate Good Manufacturing Practices (GMPs) for drug products and natural health products
• Domestic fabricators/manufacturers, packagers/labelers, and importers must have a Site Licence. Sites with a site licence must comply with the NHP GMPs
• Importers must also appoint a Quality Assurance (QA) person in Canada to disposition product and to ensure compliance

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Did you know? Quality & Compliance Services Inc. has advised and consulted on NHPs for many companies - we are familiar with the nuances of these new regulations, and continue to stay up to date regarding ongoing changes as they evolve. Our GMP associates are uniquely qualified to consult on NHPs; we were assisting clients with the transition from DIN to NHP before initial guidances were fully posted on the NHPD website.

	Exporting a Cosmetic

Cosmetics are best defined by what they are not. They are not: Products that have a therapeutic claim or that contain certain ingredients not permitted in cosmetics, for example sunscreens - these are considered drugs Products containing natural therapeutic ingredients, for example many toothpastes - these are considered natural health products (NHPs) Items where ingestion is intentional and that do not have a therapeutic effect or claim - these are considered food products Insect repellent lotions and sprays - these are considered pesticides Products providing a therapeutic benefit to animals (e.g., creams, lotions, or shampoos) - these are considered veterinary drugs

Each of these categories are regulated under the Food and Drugs Act, which defines cosmetics as "any substance or mixture of substances manufactured, sold, or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes".