Health Canada has announced a new pilot program to streamline the importation of non-compliant drugs, NHPs and cosmetics that will be modified or re-labelled prior to sale, in order to bring those products into compliance.
Importers will now be able to notify Health Canada of multiple products imported within a three month period using the Advance Notice of Importation Form. Previously, importers were required to notify Health Canada prior to each proposed commercial importation.
The pilot program does not guarantee importation of all non-compliant drugs, NHPs, and cosmetics and applies in the following four scenarios:
- cosmetics requiring modification/relabelling prior to being sold as cosmetics in Canada;
- drugs requiring modification/relabelling prior to being sold as cosmetics in Canada;
- drugs that hold a valid Canadian market authorization (DINs, DIN-HMs and NPNs) and require modification/relabelling prior to being sold as drugs in Canada; and
- drugs requiring modification/relabelling prior to being sold as foods in Canada.
The pilot program runs from March 13, 2015 to March 11, 2016. Health Canada may conduct compliance monitoring activities during the pilot program. Non-compliant importers may be subject to enforcement action, including requests to stop sale, exclusion from the pilot program, and refusal of non-compliant shipments at the border.
For more information and to request a copy of the Advance Notice of Importation Form, please click here.