Advance notice of importation process for cosmetics and drugs

The advance notice of importation process applies to cosmetics and drugs that need to be modified or relabelled to be sold in Canada.

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Background

Health Canada's evaluation of the advance notice of importation pilot process for cosmetics and drugs is complete. Based on the evaluation, this process will continue. There will be no changes to the current process and requirements, including the 3-month blanket period. We have updated and replaced the previous version of the advance notice of importation form with a PDF version.

Contact us for the latest advance notice of importation form.

Importing non-compliant cosmetics and drugs (including health products) for the purpose of sale is prohibited under the Cosmetic Regulations (CR) and Food and Drug Regulations (FDR). However, both of these regulations allow for non-compliant cosmetics and drugs to be imported under 2 conditions:

  • the importer provides advance notice to a Health Canada inspector of the proposed importation
  • the product is relabelled or modified as required for its lawful sale in Canada

Scope

The advance notice of importation process must be followed as per s. 9 of the Cosmetic Regulations and A.01.44 of the Food and Drug Regulations. It applies to:

  • cosmetics requiring modification or relabelling prior to being sold as cosmetics in Canada
  • drugs requiring modification or relabelling prior to being sold as cosmetics in Canada
  • drugs requiring modification or relabelling prior to being sold as foods in Canada
  • drugs that hold a valid Canadian market authorization (Drug Identification Number (DIN)/Homeopathic Medicine Number (DIN-HM)/ Natural Product Number (NPN)) and require modification or relabelling prior to being sold as drugs in Canada

Advance notice of importation

S.9 of the Cosmetic Regulations and A.01.044 of the Food and Drug Regulations require importers to provide Health Canada with advance notice of each proposed importation. Regulated parties may fill out the advance notice of importation form for multiple imports covering a 3-month period on a single form.   

At the border

Upon arrival at the Canadian border, the Canada Border Services Agency (CBSA) refers cosmetics and drugs to Health Canada, who assess them to see if they are subject to s.9 of the CR and A.01.044 of the FDR.

Submitting an advance notice of importation form does not guarantee cosmetics and drugs entry into Canada. Health Canada will recommend refusal of cosmetics and drugs that do not meet all requirements. This includes:

  • products that cannot be modified or relabeled to comply with regulatory requirements
  • unauthorized drugs waiting for the issuance of a market authorization by Health Canada, including a:
    • DIN
    • NPN
    • DIN-HM
    • notice of compliance (NOC)

The future issuance of market authorizations is not considered to meet the modification or relabelling conditions of the Food and Drug Regulations.

Compliance and enforcement

Health Canada may conduct monitoring activities to measure industry's compliance with the modification or relabelling requirement after import. Importers that do not comply with these requirements will be subject to compliance and enforcement action in accordance with:

Compliance and enforcement actions may include:

  • refusal of future shipments
  • stop-sale requests of non-compliant products
  • requirement of advance notice for each individual importation of products that need relabelling or modification rather than 1 form covering a 3-month period

Contact us

Contact your nearest regional Health Canada office to:

  • request a copy of the advance notice of importation form and instruction document
  • ask questions about the advance notice of importation process
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