Resources for Navigating NHP Regulations

The Natural Health Products Regulations (NHPR) apply to manufacturers, packagers, labellers, distributors, importers, and retailers of NHPs in Canada. They govern product licensing, site licensing, Good Manufacturing Practices (GMPs), clinical trials, and labelling information.

The NNHPD has provided a number of guidance documents to help the NHP industry understand, and comply with, the regulatory requirements of the NHPR. Below are links to some key guidance documents relevant to individuals invested in the NHP industry.

Licensing

• Natural Health Product Management of Application Policy (NHP MAP)
• Pathway for Licensing Natural Health Products Making Modern Health Claims
• Pathway for Licensing Natural Health Products used as Traditional Medicines
  
• Natural Health Product Licence Amendment Notification Form User Guide
• Site Licensing Guidance Document
• Web-based Natural Health Product Licence Application Form (web PLA form)
• Finished Product Specifications (for Product Licence Applications)

Quality, safety and efficacy:

• Clinical Trial Guidance Document
• Quality of Natural Health Products Guide
• Good Manufacturing Practices Guidance Document
• Reporting Adverse Reactions-Guidance Document for Industry
  
• Good Manufacturing Practices Guide  - Manufacture of Sterile Drugs 
• Quality Guidelines - ICH

Advertising and labelling:

• Guidelines for Consumer Advertising of Health Products
• Labelling Guidance Document
• Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products

Food/NHP Interface:

• Category Specific Guidance for Temporary Marketing Authorization: Supplemented Food
• Classification of products at the food-natural health product interface: products in food formats 

Further information pertaining to products at the Food/NHP Interface can be found here on the Food Regulations page.

Other Resources

The NNHPD offers a range of other resources that are useful for the NHP industry, including:

• The Licensed Natural Health Products Database
  Information about all NHPs that have been issued a product licence (NPN) by Health Canada, such as medicinal ingredients, dosage and recommended use.
  
  
• Natural Health Products Ingredients Database
  Database of ingredients for use in product applications.
  
  
• Compendium of Monographs
  Pre-cleared information (PCI) that supports the safety, efficacy and quality of an ingredient or product that the NNHPD has deemed acceptable.

• NNHPD Contact Information
  

Compliance and Enforcement

The following policies apply to NHPs: 

• Compliance and Enforcement Policy (POL-0001)  Describes how national compliance and enforcement program is delivered; as well as the roles and responsibilities of regulated parties, consumers and health care professionals in ensuring the safe and effective manufacture and use of health care products. 
  
  
• Natural Health Products Compliance & Enforcement policy (POL-0044)
  Further describes the compliance approach outlined in the Inspectorate's Compliance and Enforcement Policy (POL-0001) as it relates to NHPs. 
  
  
• Import and Export Policy for Health Products under the Food and Drugs Act and its Regulations (POL-0060)
  Outlines the Inspectorate's position with respect to the importation to Canada, and the exportation from Canada, of health products. More information on how the Inspectorate delivers compliance and enforcement for NHPs can be found here