Important Information to Stakeholders - Implementation of Advance Notice of Importation Process Pilot for Cosmetics and Drugs [Health Canada, 2015]
Please note that the Advance Notice of Importation process pilot is still under evaluation and that the one-year period for the pilot is being extended until completion of the evaluation.
Health Canada is informing stakeholders of a one-year pilot, from March 13, 2015 to March 11, 2016, concerning the implementation of a process for the advance notice of importation of cosmetics and drugs under section (s.) 9 of the Cosmetic Regulations (CR) or s.A.01.044 of the Food and Drug Regulations (FDR).
The importation for sale of non-compliant cosmetics and non-compliant drugs, including Natural Health Products (hereinafter referred to as "drugs") is prohibited under section 5 of the CR and section A.01.040 of the FDR, respectively. However, s.9 of the CR and s.A.01.044 of the FDR allow for the importation of non-compliant cosmetics and drugs provided two specific 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 with the advance notice of importation provision, Health Canada is implementing an Advance Notice of Importation Process pilot.
The Advance Notice of Importation Process pilot applies to commercial importations of cosmetics and drugs imported into Canada that will be modified or relabelled prior to being sold, as per s.9 of the CR or s.A.01.044 of the FDR, in order to enable their sale to be lawful in Canada.
The Advance Notice of Importation Process pilot applies to 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 (Drug Identification Number (DIN)/Homeopathic Medicine Number (DIN-HM)/ Natural Product Number (NPN)) 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.
Advance Notice of Importation
Currently, when invoking s.9 of the CR or s.A.01.044 of the FDR, importers are required to provide Health Canada with advance notice of each proposed importation. For the duration of the 1 year pilot, regulated parties may use the Advance Notice of Importation Form to provide Health Canada with advance notice of multiple products imported within a 3 month period.
At the border
Upon importation, cosmetics and drugs subject to a valid Advance Notice of Importation are deemed to comply with the advance notice requirements of s.9 of the CR and s. A.01.044 of the FDR. When referred to Health Canada by the Canada Border Services Agency (CBSA), these products remain subject to inspection by Health Canada.
The submission of an Advance Notice of Importation Form does not guarantee that importations of cosmetics or drugs will be allowed entry into Canada. Non-compliant cosmetics and drugs that do not meet all requirements of s.9 of the CR or s. A.01.044 of the FDR respectively, such as products that cannot be brought into compliance by means of relabelling or modification, will be recommended for refusal if referred to Health Canada by the CBSA for an admissibility determination. This includes unauthorized drugs that are proposed to be imported in Canada to await the issuance of a market authorization (DIN, NPN, DIN-HM or Notice of Compliance (NOC)) by Health Canada. The future issuance of market authorizations is not considered to meet the modification or relabelling conditions of s.9 of the CR or s.A.01.044 of the FDR.
Compliance and Enforcement
During the pilot, Health Canada may conduct compliance monitoring activities to gather information about industry's compliance with the modification or relabelling requirement following importation. Importers that do not comply with the modification or relabelling requirement will be subject to compliance and enforcement action in accordance with the Healthy Environments & Consumer Safety Branch Compliance and Enforcement Policy for cosmetics or the Health Product and Food Branch Inspectorate Compliance and Enforcement Policy (POL-0001) for drugs. Compliance and enforcement actions may include a request to stop sale of non-compliant products, the refusal of future shipments imported under s.9 of the CR or s.A.01.044, or the importer may be excluded from the pilot and may be required to submit advance notice for each individual importation of products requiring relabelling or modification.
During the 1 year Advance Notice of Importation Process pilot, Health Canada will evaluate the process, measure its success and identify lessons learned to determine next steps. Any change in process will be communicated to stakeholders with sufficient notice to allow industry to make any necessary adjustments in order to comply with the advance notice requirement.
You can contact your Regional Health Canada Office at the coordinates below to request a copy of the Advance Notice of Importation Form and Instruction Document. Regional Offices can also be contacted for questions and comments concerning the pilot process.
|Regional Office||Address||TelephoneTable 1 footnote 1|
|Atlantic||Regions and Programs Bureau (RAPB)
Suite 1625, 16th Floor
1505 Barrington Street
Halifax, Nova Scotia
|Quebec||Regions and Programs Bureau (RAPB)
1001 St-Laurent Street West
|Ontario||Regions and Programs Bureau (RAPB)
2301 Midland Avenue
|Manitoba-Saskatchewan||Regions and Programs Bureau (RAPB)
300-391 York Ave.
|Alberta||Regions and Programs Bureau (RAPB)
730 - 9700 Jasper Ave.
|British-Columbia||Regions and Programs Bureau (RAPB)
4595 Canada Way
Burnaby, British- Columbia
Table 1 footnotes
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