Request a Demo1. Definition & classification
Under the Natural Health Products Regulations, Natural Health Products (NHPs) refers to substances naturally occurring, including vitamins, minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, and other products like amino acids and essential fatty acids, that are used to restore or maintain good health.
2. Competent authority
Competent authority | Responsibility |
Health Canada (HC) | HC is responsible for establishing national health policies and regulations related to food safety and nutrition, as well as standards for food additives, contaminants, and food labeling. It ensures that food products sold in Canada are safe for consumption and meet high standards of public health. |
Natural and Non-prescription Health Products Directorate (NNHPD) | NNHPD regulates NHPs through a comprehensive framework that includes the issuance of Natural Product Numbers (NPNs), Good Manufacturing Practices (GMPs), labeling and packaging requirements, as well as post-market surveillance and reporting. |
Canada Border Services Agency (CBSA) | CBSA regulates the entry of food products into the country, ensuring their compliance with Canada's safety and quality standards at the border in conjunction with CFIA and Health Canada. It monitors and enforces regulations related to food imports, including preventing the entry of non-compliant and unsafe products, while facilitating legitimate trade and protecting Canadian consumers. |
3. Market access approval
3.1 Product license
In Canada, all NHPs must obtain a product license before they can be sold in the market. To obtain this license, manufacturers and distributors must submit a Product License Application (PLA) that includes comprehensive information about the product, such as its medicinal and non-medicinal ingredients, dosage, potency, and recommended uses. Once the product has undergone assessment and is deemed safe, effective, and of high quality, a product license will be issued. The license is accompanied by an 8-digit Natural Product Number (NPN) or Homeopathic Medicines Number (DIN-HM) which must appear on the label. PLA should be submitted via Natural Health Products Online System. Licensed NHPs can be searched at here.
3.2 Site license
Canadian manufacturers, importers, labellers and packagers of NHPs must have site licenses. To obtain a site license, entities must submit a Site License Application (SLA) along with supporting documentation that demonstrates their adherence to appropriate GMPs in the manufacturing, packaging, labeling, and importation processes of NHPs. Foreign sites may also apply for Foreign Site Reference Number (FSRN) and authorize Canadian importers to reference the FSRN as an alternative to providing GMP evidence for the foreign sites. Site License Application (SLA) should be submitted via Web based SLA form. Site license and foreign site reference number holders can be searched at here.
4. Product compliance
4.1 Product requirements
Product requirements for NHPs are established in Natural Health Products Regulations and Good Manufacturing Practices, including requirements for the manufacturing, packaging, and labeling of NHPs, regardless of whether the product is manufactured in Canada or in another country whose manufacturing regulations may differ from those of Canada.
Additionally, for the use of permitted medicinal and non-medicinal ingredients, please refer to Natural Health Products Ingredients Database.
4.2 Label
The labeling of NHPs shall meet Natural Health Products Regulations, including general labeling requirements such as language, exemption, formats and information display provisions. For example, for products with both inner and outer labels, certain information must be located on the outer label, such as the Product Facts Table.
For more information about the labeling and claims of NHPs, please refer to Labelling of Natural Health Products.
* Global Food Compliance Service
We provide various market entry services to help stakeholders better understand exporting requirements, establish business and secure a competitive place to facilitate trade development.
Covered Countries
China, Thailand, Vietnam, Singapore, Malaysia, Philippines, Indonesia, Japan, South Korea, United States, European Union, Australia, New Zealand etc.
Our Services
Food Ingredient Review
Label Review
Product Registration
Regulatory Consultation
Monitoring, Training and customized report
Please feel free to contact us via food@chemlinked.com if you need any help.
