Natural Health Product Regulatory Compliance Services
For a Natural Health Product to be lawfully sold in Canada it must apply for and receive a license from Health Canada which is called a Natural Product Number or NPN#, which once issued needs to be displayed on the product label on every bottle or box. Links can assist you in obtaining your NPN# as well as to have your manufacturer annexed to our Health Canada site license.
To import or distribute Natural Health products in Canada, it is mandatory for the importer or distributor to have a Health Canada site license and to adhere to Good Manufacturing practices as required by Health Canada GMP Guidance Document on Natural Health Products.
The site license holder becomes responsible to ensure that a product meets its specifications and has two aspects. The first is that product specifications are established, and the second is that the manufacturer has a quality system in place that ensures the product consistently meets the established specifications. Finished product tests complement the controls employed during the manufacturing and importing processes. It is the responsibility of each manufacturer and importer to have accurate specifications, adequate quality systems in place, and appropriate test methods that will help ensure that each NHP sold meets the product specifications.
To meet the requirements
The manufacturer, importer and, if applicable, packager shall ensure the following. Alternatively, justifications with rationale for the exemption of the requirements should be provided.
- Develop and implement written specifications for all finished products pertaining to identity, purity, quantity, potency, and tolerances as per the Quality of Natural Health Products Guide.
- Ensure specifications are maintained and every change is approved by the QAP prior to use. Changes to specifications as per section 11(i) of the Regulations requires an amendment to the product license.
- Set up and follow written procedures that describe tests to be conducted to ensure the identity, purity, and quantity of finished products. When applicable, these procedures should include potency testing.
- Verify that all test methods provide accurate and consistent results.
- Assess each lot for compliance with specifications prior to release.
Importers are required to review a supplier’s certificate of analysis (CoA) submitted with each lot received to ensure the product meets specifications. This review should cover verification that all required testing is performed and that specifications are met.
For all testing methods and requirements, please refer to the Quality of Natural Health Products Guide.