Features of Canadian-made products
The world's most rigorous licensing standards
Canadians can identify NHPs that have been licensed for sale by Health Canada by looking for the eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM) on the label.
A NPN or DIN-HM on a label means that the product has been authorized for sale in Canada and is safe and effective when used in accordance with the instructions on the label.
Site licensing and GMP license in Canada
All Canadian manufacturers, packagers, labellers, and importers of NHPs must have site licenses. To get a licence, sites must maintain proper distribution records, have proper procedures for product recalls and for the handling, storage and delivery of their products, and demonstrate that they meet good manufacturing practice requirements.
Good Manufacturing Practices
Good Manufacturing Practices make sure proper standards and practices for the testing, manufacture, storage, handling and distribution of NHPs are met. Good Manufacturing Practices for NHPs cover:
Product specifications
Premises
Equipment
Personnel
Sanitation program
Operations
Quality assurance
Stability
Records
Sterile products
Lot or batch samples
Recall reporting
Good Manufacturing Practices are meant to ensure safe and high quality products while giving manufacturers, packagers, labellers, importers and distributors the flexibility to implement quality systems appropriate for their product lines and businesses. More information on Good Manufacturing Practices for NHPs is available in the Good Manufacturing Practices Guidance Document.
Natural Health Products Regulations in Canada
The Natural Health Products Regulations were created after many consultations with Canadian consumers, academics, health care practitioners and industry stakeholders. They address Canadians' concerns about NHP availability and safety, as well as the House of Commons Standing Committee on Health's 53 recommendations on the regulation of NHPs in Canada.
To be legally sold in Canada, all NHPs must have a product licence, and the Canadian sites that manufacture, package, label and import these products must have site licences.
To get product and site licences, specific labelling and packaging requirements must be met, good manufacturing practices must be followed, and proper safety and efficacy evidence must be provided.