Health Canada’s New Advance Notice of Importation Process Pilot Offers More Convenience and Flexibility to Importers of Drugs, NHPs, and Cosmetics.

As regulatory consultants for the U.S. and Canada, dicentra is often asked by clients, “Is it acceptable for us to ship product to Canada that is manufactured or labelled for the U.S. provided we modify or re-label the product after arrival in Canada?” This often happens in situations where a company wishes to transfer stock to Canada due to excess U.S. stock, or in backorder situations where a company needs to ship product immediately to Canada. In many instances, it is simply more expedient and/or cost effective to modify the product or label north of the border.

Companies who face this situation will be interested to learn that Health Canada has recently launched a new Advance Notice of Importation Process Pilot that will facilitate the importing of non-compliant products under section S.9 of the Cosmetic Regulations and Section s.A.01.044 of the Food and Drug Regulations. Bringing non-complaint product across the border is nothing new – This has always been possible under the existing regulations. However, whereas before notification had to be given for each shipment, under the new pilot a single notification can be submitted covering multiple shipments for multiple products over a 3 month period.

To take advantage of the new Advance Notice of Importation Process pilot initiative, an importer must undertake the following steps:

1. Ensure that the product can and will be modified or labelled to make it compliant with Canadian Law
2. Complete an Advanced Notice of Importation Form. Forms are available from the Inspectorate and require that you provide your company details, shipping details, and product details, and that you outline the corrections/modifications that will be undertaken.
3. Submit the form to your regional Health Canada Office by email in advance of the shipment.
4. Ensure that the product is relabelled or modified within 3 months of the importation.

Bear in mind that the pilot project applies to only certain types of commodities and this can be a source of great confusion. This is especially true because how a commodity is classified in Canada may be different to how it is classified abroad. The pilot initiative specifically applies to the following scenarios:

• Are you importing a non-compliant Cosmetic? – Then you may modify or re-label it under the pilot program to produce a complaint Cosmetic
• Are you importing a Drug or Natural Health Product (NHP) that is non-complaint but that holds a valid licence (DIN, DIN-HM, or NPN)? – Then you may modify or re-label it under the pilot program to produce a complaint Drug or NHP
• Are you importing a Drug or NHP that is non-complaint but that does not hold a valid licence (DIN, DIN-HM, or NPN)? – Then you may modify or re-label it under the program to produce a complaint Food or Cosmetic.

Note that you cannot bring a non-compliant food into the country under the pilot, or make a non-compliant cosmetic a complaint drug, or make a non-compliant licenced drug or NHP a compliant food or cosmetic, or make a non-complaint unlicenced drug or NHP a complaint drug or NHP.

It is also important to remember that uses of the terms “drug”, “cosmetic”, “NHP” or “Food” are as they are defined in Canada. Consider the following scenario:

You wish to import a Vitamin B Tablet product from the U.S. The product has an NPN, but is labelled as a dietary supplement, which you intend to over-label to make it a compliant NHP. At first glance, you may think that such a product would not qualify for importation under the pilot because it is classified as a food in the U.S. However, since an encapsulated Vitamin B product with health claims is considered an NHP in Canada, such a product would qualify for importation under the program.

While the new pilot offers more convenience and flexibility, failure to comply with the conditions of the pilot as outlined above may result in a stopped shipment at the border or subsequent enforcement actions including stop sale or recall. The pilot will run from March 13, 2015 to March 11, 2016. Depending on the outcome, the new process may be modified, extended, and/or formally adopted at the end of the pilot period.

dicentra provides sought-after guidance on product and marketing compliance, quality assurance and safety standards, research and development, new ingredient assessments and overall regulatory strategies for food and health-related products sold in North American marketplaces. We can assist you with navigating the Advanced Notice of Importation Process Pilot to confirm that you meet the requirements of the pilot and file the notice for your products, as needed. We can be reached at 1-866-647-3279 or info@dicentra.com.