The importation for sale of non-compliant cosmetics and drugs, including Natural Health Products is prohibited as per the Cosmetic Regulations and Food and Drug Regulations. However, the Regulations do allow for the importation of non-compliant cosmetics and drugs provided the following two conditions are met:
- The importer provides advance notice to a Health Canada inspector of the proposed importation; and
- The product is relabelled or modified as required to enable its sale to be lawful in Canada.
In order to promote compliance, Health Canada is implementing a 1 year Advance Notice of Importation Process pilot from March 13, 2015 to March 11, 2016. The pilot applies to commercial importations of cosmetics and drugs imported into Canada that will be modified or relabelled prior to being sold to be compliant. Currently, importers are required to provide advance notice for each proposed importation, however for the duration of the 1 year pilot, importers may use the Advance Notice of Implementation Form for multiple products imported within a 3 month period. The purpose of the form is to flag shipments that could otherwise be refused entry at the border due to non-compliance.
The following four scenarios apply to the pilot project:
- Cosmetics requiring modification/relabeling prior to being sold as cosmetics in Canada
- Drugs requiring modification/relabeling prior to being sold as cosmetics in Canada
- Drugs that hold a valid product license (i.e. DIN, NPN, DIN-HM) and require modification/relabeling prior to being sold as drugs in Canada
- Drugs requiring modification/relabeling prior to being sold as foods in Canada
The submission of the Advance Notice of Importation Form does not guarantee that importation of cosmetics and drugs will be allowed entry into Canada. Non-compliant cosmetics and drugs that do not fall into one of the above four scenarios may be recommended for refusal at the border. Product applications currently under review with Health Canada are not considered to meet the modification or relabeling conditions.
If your product is already fully compliant with the Cosmetic Regulations and Food and Drug Regulations the Advance Notice of Implementation form is not required.
Contact DSA Consultants for assistance with Health Canada requirements for importation of drugs, medical devices, natural health products or cosmetics.