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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