Frequently Asked Questions
There is a lot of unusual terminology within the Natural Health Product space in Canada, most of which originates from Health Canada and the various regulations and laws. This page is a collection of the most frequently asked questions we get.
What is a Natural Health Product (NHP)?
Natural health products (NHPs) are defined in the Natural Health Products Regulations as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines (like traditional Chinese medicines), probiotics, and other products like amino acids and essential fatty acids.
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How are NHPs licensed in Canada?
All NHPs sold in Canada are subject to the Natural Health Products Regulations which came into force on January 1, 2004. All products must have a product licence and Canadian sites that manufacture, package, label and import these products must have site licences.
To obtain these licences, specific labelling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.
The licensing requirements apply to any person or company that manufactures, packages, labels and/or imports NHPs for commerical sale in Canada. They do not apply to healthcare practitioners who compound products on an individual basis for their patients, or to retailers of NHPs.
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What is an NPN?
A Natural Product Number (NPN) is issued by Health Canada after a product has been assessed as safe, effective and of high quality. Each NPN is 8 digits long and must appear on the product label.
Consumers know that this means the product has been reviewed and approved by Health Canada.
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What is a DIN-HM number?
Homeopathic medicines are issued a DIN-HM after Health Canada has assessed a product for its safety, efficacy and quality. This number must appear on the product label.
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What is an EN number?
An Exemption Number is granted by Health Canada for NHPs that have been initially assessed for their safety but haven't been fully evaluated. These products can be legally sold as long as this EN number is listed on the product label.
An EN number looks like this: EN-123456
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What is a 'Schedule A' disease?
Schedule A is a list of diseases, disorders or abnormal physical states that are defined in the Food and Drugs Act (1985). This includes such things as acute anxiety, asthma, cancer and diabetes.
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What is an IRN?
An Information Request Notice is simply a letter from Health Canada requesting further information to continue its assessment of your licence application. The applicant is given 30 calendar days to provide the information.
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What is a Site Licence?
All Canadian manufacturers, packagers, labellers, and importers of Natural Health Products (NHPs) must have site licences. To obtain a licence, sites must maintain proper distribution records and have proper procedures for product recalls, handling, storage and delivery of their products. They also need to demonstrate that they meet Good Manufacturing Practice (GMP) requirements.