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
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:
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: