Selling in Canada
Puresource’s regulatory affairs team is kept up-to-date and informed with regulations that appear to be ever changing in Canada. Health Canada and the Canadian Food Inspection Agency (CFIA) are the two main branches of the Canadian government that regulate all products distributed by Puresource.
Please review the information below to help you understand how to sell your product in Canada.
Natural Health Products
Natural Health Products (NHPs) are defined as:
1) Vitamins and minerals ;
2) Herbal remedies;
3) Homeopathic medicines;
4) Traditional medicines such as traditional Chinese medicines;
5) Probiotics;
6) Other products like amino acids and essential fatty acids.
Natural Health Products (NHPs) require premarket authorization and must be licensed for sale in Canada according to the Natural Health Product Regulations. Licensed products are assigned a natural product number (NPN) that must appear on the principal display panel (front) of the product. NHP’s requires approval prior to sale by the Natural Health Products Directorate for efficacy and safety, either as a traditional or non-traditional NHP. The quality of the NHP needs to meet the requirements of the Evidence for Quality of Finished Natural Health Products. The manufacturing of an NHP needs to meet the requirements of the current guide for Good Manufacturing Practices. Puresource has a valid Site License for manufacturing, packaging & Labelling, importing and storing NHP’s. A foreign site may obtain a Foreign Site Reference Number to allow a Canadian importer to sell their NHP product in Canada. The foreign site can provide a completed Foreign Site Reference Number Authorization form to the importer, so that the Canadian Site License holder can include the foreign site on their Site License. If you require assistance with the requirements for registering or selling your NHP in Canada, then please contact a Puresource recommended regulatory consultant. If you require assistance with the requirements for registering or selling your NHP in Canada, then please contact a Puresource recommended regulatory consultant.
Foods (organic, gluten-free, table top sweetener, etc.)
Foods are regulated by the Canadian Food Inspection Agency in Canada. The main document that outlines requirements for the labeling of food products is the Guide to Food Labelling and Advertising. Importing foods requires Puresource to follow current Good Importing Practices for Food. Cosmetics (personal care product) Cosmetics are regulated by the Product Safety Programme section of Health Canada. Cosmetics require a cosmetic notification to be completed and sent to Health Canada within the first 10 days of sale. Please see the guidelines for cosmetic labeling in Canada. Ingredient lists need to meet the requirements of the International Nomenclature of Cosmetic Ingredient (INCI). Health Canada keeps a Hot List of cosmetic ingredients that provide guidance on the levels acceptable in a given cosmetic product. A cosmetic product needs to be manufactured according to Good Manufacturing Practices.
Consumer Products (household cleaning product)
Consumer Products are regulated by the Product Safety Programme section of Health Canada. Consumer products have labeling requirements dependent on whether they may have a chemical, flammability, or mechanical and electrical hazards. Appropriate packaging and labeling is required for each class of product. All consumer products need to meet the requirements for the Canada Consumer Product Safety Act .
Pest Control Products (insect repellent)
The Pest Management Regulatory Agency regulates this class of product in Canada. All products that carry a claim to control, destroy, attract or repel a pest is considered a Pest Control Product. A Pest Control Number must be registered for all Pest Control Products sold in Canada. The Consumer Product Safety group is the section of Health Canada that reviews shipments referred by Canada Customs, and acts on trade and consumer complaints.
Medical Devices & Drug Products (feminine hygiene product – therapeutic products or sanitizers that do not meet the definition of an NHP).
Medical Devices
The Therapeutic Products Directorate (TPD) is the section of Health Canada that regulates this class of products in Canada. All products that carry a therapeutic claim and used as a device are considered Medical Device License must be registered for each Medical Device sold in Canada. Facilities that manufacture, package, label, import or distribute Medical Devices are required to have a current Medical Device Establishment License. The Medical Device needs to comply with current ISO quality management system standards. The Health Protection and Food Branch Inspectorate is the section of Health Canada that completes GMP audits of facilities that manufacture, import, package, label or distribute Medical Devices in Canada. They also review shipments referred by Canadian Border Services, and acts on trade and consumer complaints.
Drug Products
The Therapeutic Products Directorate is the section of Health Canada that regulates this class of product in Canada. All products that carry a therapeutic claim and are excluded form the definition of a Natural Health Product are considered drugs. A Drug Identification Number (DIN) must be registered for all drug products sold in Canada. Facilities that manufacture, package, label, import or distribute drug products are required to have a current Establishment License that require compliance with the current Health Protection and Food Branch Inspectorate is the section of Health Canada that completes GMP audits of drug facilities, reviews shipments referred by Canada Customs, and acts on trade and consumer complaints.
Canadian Labeling:
Canada has two official languages (English and French) and all labeling is required to be in both official languages. Languages are also regulated by the provinces. In Quebec, there are regulations that require French to have equal prominence with English label text.
Regulatory Consultants:
Please feel free to contact any of these consultants below to help you with your product submission.
MCS Associates Inc.
Web Site http://www.mcs-associates.com/index.php
dicentra Regulatory & Scientific Solutions
Web Site https://dicentra.com
Natural Health Products Consulting Corp.
Web Site https://www.npc-corp.ca
