New Pilot Program to Streamline Cosmetic and Drug Imports

Health Canada recently announced the start of a one-year Advance Notice of Importation Process pilot program.¹ The program, now in operation, streamlines the process for importing cosmetics and drugs into Canada and will continue until March 11, 2016.

Canadian regulation prohibits the import of non-compliant cosmetics and drugs; however, Health Canada will permit the import of non-compliant products if: the importer provides advance notice of a proposed import to a Health Canada inspector; and the imported product is relabeled or modified to comply with Canadian regulations within 3 months of import.

What You Need To Know

• The pilot program authorizes Health Canada to allow importers to provide a single Advance Notice of Importation Form to gain approval for multiple imports of products within a specified 3-month period (rather than importers giving advance notice and obtaining approval for each separate import).
• The import of non-compliant cosmetics and drugs is only permitted if the product is approved for sale—the new program does not allow the import of drugs with pending Canadian marketing authorization.
• The import exemption does not waive any other regulatory requirements for marketing cosmetics or drugs in Canada. For instance, while drugs with non-compliant labels may be imported into Canada for relabeling or modification, any such relabeling or modification must be performed at a facility approved for such activity under a Drug Establishment License.

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¹ http://www.hc-sc.gc.ca/dhp-mps/compli-conform/import-export/notice-avis-eng.php