|Legislation:||Food and Drugs Act|
|Regulation:||Natural Health Products Regulations
Natural Health Products (Unprocessed Product License Applications) Regulations
|Regulating Authority:||Natural Health Products Directorate, Health Canada|
|Inspection Authority:||Health Products and Food Branch Inspectorate, Health Canada|
|Applications and Submissions:||Index|
|Licensed product database:||Licensed Natural Health Products Database|
|Exempted product database (EN):||NHP Exempted Products Database|
What is a natural health product?
Natural health products (NHPs) are defined in the Natural Health Products Regulations as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as Traditional Chinese Medicines, probiotics, and other products like amino acids and essential fatty acids.
Under the Regulations, the product must be safe for consideration as a nonprescription product. Natural health products are available for self-care and self-selection, and do not require a prescription to be sold. Products requiring a prescription will continue to be regulated under the Food and Drug Regulations.
How does a natural health product get to market?
In order to market your products in Canada, the Natural Health Products Regulations first require you to obtain the necessary product and site licenses1.
Before any natural health product can be sold in Canada, it must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality1. Evidence demonstrating this must be submitted to Health Canada by means of a product license application (one for each product). Products, which meet the required criteria, will be authorized for sale and issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Further information on this process is available in the Product Licensing Guidance Document (see Product Licensing).
1NOTE: On August 4, 2010, Health Canada implemented a new regulation to manage a situation whereby a resource problem has led to a large number of natural health products being in backlog to be reviewed. The Natural Health Products (Unprocessed Product License Applications) Regulations will provide a temporary exemption (and number beginning with "EN") to permit NHPs, for which a product license application has been filed with Health Canada, but the assessment has not been completed, to be legally sold on the market. The exemption number will stay in effect until the application(s) is withdrawn or is processed and a decision to issue or refuse a license is made. These regulations will be repealed 30 months after coming into force (ie., February 2013).
The Natural Health Products Regulations require any Canadian site where natural health products are manufactured, imported, labeled, packaged, distributed, and/or stored to have a site license. Businesses can choose to have a single site license for all their operations (i.e. multiple sites) or an individual license for each site. Site licenses are obtained by demonstrating that the above-mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs. Further information is available in the Site License Guidance Document (see Site Licensing).
Currently there are no costs or fees associated with the submission and review of product and site license applications.
How does a natural health product get approved for import into Canada?
Canadian importers must have a site license and the onus is on them to provide evidence that imported products come from sites that meet the Canadian Good Manufacturing Practices (GMPs), or equivalent standards. The Canadian importer is responsible for submitting a Quality Assurance Report for each site (foreign and domestic) with their site licence application. The importer must ensure that these reports are complete and that all requirements of the GMPs are being met. Site licenses are only issued to Canadian sites (none are issued to foreign sites). Foreign manufacturers will be covered under the Canadian importer's site license.
Further information on the importation of natural health products is outlined in Section 5 of the Site License Guidance Document.
All products, whether manufactured domestically or in a foreign site, must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product license application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM)1. Further information on his process is available in the Product Licensing Guidance Document.
How can Canadians know a product has been approved for sale by Health Canada?
Once assessed by Health Canada, the product label will bear an 8-digit product license number, preceded by the letters "NPN". The NPN on the label will inform the public that the product has been reviewed by Health Canada for safety, quality, efficacy and health claims. For homeopathic medicines, the label will bear the designation DIN-HM. Products that have received an NPN are listed in Health Canada's Licensed NHP Database.
If the product has a license number beginning with "EN", it means a submission for review has been made to Health Canada, but it has not yet been reviewed. These products are legal to be sold in Canada while their submission is pending review. Products that have received an EN are listed in Health Canada's NHP Exempted Products Database.