Health Canada advises that the evaluation of the Advance Notice of Importation Process pilot has now been completed. Based on the results of this evaluation, this process for cosmetics and drugs will no longer be considered a pilot.
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 re-labelled or modified as required for its lawful sale in Canada
It applies to:
- cosmetics requiring modification or re-labelling prior to being sold as cosmetics in Canada
- drugs requiring modification or re-labelling prior to being sold as cosmetics in Canada
- drugs requiring modification or re-labelling 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 re-labelling prior to being sold as drugs in Canada
The process to import non-compliant cosmetics and drugs for re-labelling or modification to make their sale compliant in Canada remains as stated in the Advance notice of importation process for cosmetics and drugs, including the 3-month blanket period.
However, as of April 1, 2021, the current Excel-based version of the Advanced Notice of Importation form will be replaced with a fillable PDF version. Although you may continue to use the current Excel-based form during this transition period, you can contact your Regional Health Canada office to request a copy of the fillable PDF Advance Notice of Importation form to become familiar with it as well as to use it for future ANI submissions.
View the Guidance on the Advanced notice of importation process for cosmetics and drugs for more details.
Contact your nearest regional Health Canada office to request a copy of the advance notice of importation form and instruction document and for any questions about the advance notice of importation process.