Certifications / Natural Health Product Certification (Canada)

International Trade Certificates

Many countries require an international trade certificate to accompany any natural health product that is being imported for sale in the domestic market. An ITC is a document that gives information to the exporting country about the regulatory status of a Canadian NHP or NHP manufacturer, packager or labeling provider and attests that the product meets the Natural and Non-Prescription Health Product Directorate’s regulatory requirements. 

prophema is a registered third-party agency that issues ITCs within two business days from the time of payment and receipt of site and product license. This turnaround does not include the time taken for the certificate to reach you by mail. 

prophema issues the following types of ITC’s:

ITCs for NHPs

This deals with products only, and those that hold a valid NPN or DIN-HM can obtain such a certificate, though a separate application is required for each product and destination country. 

ITCs for GMP compliance

This pertains to domestic Canadian sites having a valide state license, and attests that a facility has been found to be compliant with Canada’s NHP good manufacturing practices. 

Certificates of Free Sale

A Certificate of Free Sale (CFS) is required by certain countries if you wish to import a certain commodity into that jurisdiction. The document attests that the imported goods are legally and freely sold in the open market of the country of export. This is a service designed for countries that regularly export or import products to regions that make CSFs mandatory. 

We are your best choice for CSFs, with our fast turnarounds, competitive pricing, ease of service, and notarization support. We offer CSFs for cosmetics, veterinary health products, over-the-counter medications, medical devices and disinfectants. 

Certain product categories are not included in certifications: 

Foods sold in Canada

The Canadian Food Inspection Agency provides CFSs for foods to industry.

Drugs (other than OTCs) sold in Canada

The Health Product Compliance Directorate currently issues Certificates of a Pharmaceutical Product (CPP) for these products.

Foods, Drugs, etc. sold in the USA

Foods, Dietary Supplements, Drugs, Medical Devices, or Cosmetics sold in the USA—the US FDA already issues trade certificates for these commodities.