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Best practices on advance notice of importation process for cosmetics and drugs

The advance notice of importation process applies to the import of cosmetics and drugs, including natural health products (NHPs), that need to be modified or re-labelled to be sold legally in Canada.

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Background

Importers must notify Health Canada in advance of each proposed importation of non-compliant cosmetics, drugs and natural health products (NHPs). This is required under the Cosmetic Regulations (section 9) and the Food and Drug Regulations (section A.01.044).

In 2019, Health Canada conducted a compliance monitoring project (CMP) on importers using the advance notice of importation process for drugs or NHPs. Specifically, we looked at compliance with the labelling and advertising requirements of the Food and Drugs Act and its regulations.

This CMP highlighted gaps in compliance with:

We found some areas in which importers need to improve their practices to better comply. For example, inspectors found cases where products had not been modified or re-labelled as per the notice of importation. This included labelling issues and unapproved health claims on the label or the product's website. We also found that importers didn't always make the changes within the required 3-month timeline after importation. Refer to the CMP report for more information.

To better support compliance, we've updated and replaced the Excel-based version of the form with a fillable PDF version. The new form is more user-friendly and should reduce human error. You can add, modify or delete as many products as necessary. You may re-use your saved form, update it as necessary and resubmit as a new form.

For more information or to request a copy of the advance notice of importation form, please refer to the Advance notice of importation process.

Best practices for completing the form

When submitting a form for advance notice of importation, please follow these best practices.

Do not modify the form

The form has been designed to automatically upload information into our tracking system. It won't function properly if you modify it.

Include only non-compliant drug and natural health products

Only list products that:

  • are being imported and
  • need to be re-labelled or modified in order to be sold legally in Canada

If your product doesn't need to be modified after importation, make sure that you comply with the import requirements.

To learn more about the regulation of drugs, natural health products (and cosmetics in Canada, please consult:

Indicate the correct classification at the time of importation

The correct classification is the one that's accurate at the time of importation. For example, products imported with health claims should be classified as drugs or natural health products, even if those claims are going to be removed to make them cosmetics.

We review and assess information to verify compliance of importations of health products into Canada. We consider all available information when classifying a product and determining licensing requirements for its import for sale into Canada.

This includes:

  • the product label and ingredients listed
  • leaflets
  • pamphlets
  • promotional material
  • Canadian and foreign websites, including those found:
    • on the product label
    • on promotional material accompanying the shipment
    • as links or references on other websites
    • through other sources

This information helps us assess the intended use of the product. It also helps us determine if the product meets the definition of a drug under the Food and Drugs Act.

Importers that don't comply with these requirements are subject to compliance and enforcement action in accordance with Health Canada's Policy 001.

Identify health claims

To help you identify health claims that must be removed if you intend to sell a product as a cosmetic, please consult:

You can also hire a consultant who specializes in this area.

To learn more about the regulation of drugs, natural health products and cosmetics in Canada, please consult:

Modifications and re-labelling

Indicate all modifications or re-labelling that the company expects to do. For example, you must remove all therapeutic health claims from products to be sold as cosmetics. This applies to information in all languages, and includes information found on:

  • product labels
  • websites
  • pamphlets
  • advertising
  • any other location where consumers might find it

We review and assess product labels and any associated advertising while verifying compliance of importations of health products into Canada.

Modifications to your label must hide or permanently remove the non-compliant information with:

  • a sticker
  • crossing out
  • completely modifying the label or packaging, or
  • any other methods of hiding or removing information

It's your responsibility to ensure the products you're planning to sell in Canada are compliant with Canadian regulations.

You can only sell a drug imported into Canada using the advance notice process if it's re-labelled or modified within 3 months after the importation. This applies even if the products are stored out of the public eye.

To learn more about the regulation of drugs, natural health products and cosmetics in Canada, please consult:

Licences

Before importing a drug or natural health product into Canada for the purpose of sale:

  • the drug or NHP must hold a valid Canadian market authorization:
    • Drug Identification Number (DIN)
    • DIN-Homeopathic Medicine number (HM) or
    • Natural Product Number (NPN)
  • and the importer must have a valid licence for import of the product

Similarly, the packager or labeller of a drug or NHP must have a licence to carry out such activities in Canada. Make sure that the appropriate licences for import, packaging and labelling are in place for products that will remain a drug or NHP after modification or re-labelling (Table 1).

Table 1: Summary of licensing requirements
Advance notice of importation submission Requirements

Drugs that:

  • hold a valid Canadian market authorization, and
  • require modification or re-labelling before being sold as compliant drugs in Canada

NHPs or homeopathic medicines that:

  • hold a valid Canadian market authorization, and
  • require modification or re-labelling before being sold as compliant NHPs or homeopathic medicines in Canada

Drugs that require modification or re-labelling before being sold as compliant cosmetics in Canada

  • No licensing requirements to import, re-label or repackage cosmetics
  • You must notify Health Canada within 10 days after the first sale of a cosmetic in Canada

NHPs that require modification or re-labelling before being sold as compliant cosmetics in Canada

Cosmetics that require modification or re-labelling before to being sold as compliant cosmetics in Canada

To learn more about importation requirements, please refer to the following links.

To learn more about the regulation of drugs, NHPs and cosmetics in Canada, please refer to the following links:

Health Canada approval

An advance notice of importation does not constitute Health Canada's approval of the product for sale in Canada. You must not use any language implying that the product has been verified or approved by Health Canada or the Government of Canada. This applies to all marketing, advertising and promotional materials relating to the product.

Submission of a cosmetic notification form to Health Canada does not mean:

It's your responsibility to make sure that products you're planning to sell in Canada are compliant with Canadian regulations. To learn more about the regulation of drugs, natural health products and cosmetics in Canada, please refer to the following links:

Advance notification of importation for medical devices

The notification process for medical devices is slightly different from that of drugs and natural health products. Devices that have non-compliant labelling may be imported with advance notice to Health Canada for corrective measures to be undertaken before sale.

Please refer to the guidance document for more information:

Contact us

If you have questions about the advance notice of importation process for drugs, natural health products or cosmetics, please contact your Regional Health Canada office.

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