Notice - Revisions to the Guidance on the Application for International Trade Certificates for Natural Health Products

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December 2009

Summary

The Natural Health Products Directorate (NHPD) will modify its current approach to International Trade Certificates (ITCs) for natural health products (NHPs). The purpose of this communiqué is to inform stakeholders of upcoming revisions to the Guidance Document on the Application for International Trade Certificates for Natural Health Products. These changes will ensure Canada's global reputation as a leader in the regulation of NHPs, and as an exporter of NHPs that are safe, effective and of high quality. These changes will be reflected in the revised Guidance Document on the Application for International Trade Certificates for Natural Health Products.

Background

Since the adoption of the Natural Health Products Regulations (NHPR) in January 2004, NHPD has issued ITCs for NHPs as a service to industry in order to facilitate the export and customs process for NHPs. Three types of export certificates have been issued. They are:

• Type I: International Trade Certificate for NHPs: issued to NHPs which possess a valid product licence in the form of a Natural Product Number (NPN) or a DIN Homeopathic Medicines Number (DIN-HM) and which are manufactured, packaged and labelled in licensed sites;
• Type II: International Trade Certificate for NHPs Intended for Export Only: issued to NHPs manufactured in Canada for export only. The issuance of the certificate does not require a valid product licence or that the NHPs be manufactured in a licensed site;
• Type III: Certificate of Good Manufacturing Practices (GMPs) Compliance: issued for licensed sites which are GMP compliant.

ITCs are not required under the Natural Health Products Regulations; rather, NHPD voluntarily issues them upon request by Canadian manufacturers as a service to industry. Currently there is no fee associated with the issuance of ITCs for NHPs.

Products for Export Only - Section 37 of the Food and Drugs Act

The Natural Health Products Regulations apply to the manufacturing, packaging, labelling, importation for sale, distribution and storage of natural health products in Canada. Products which are manufactured solely for the purpose of export, for example, products that are not fabricated for consumption or sale in Canada, may be exempted from the requirements of the Food and Drugs Act and the Natural Health Products Regulations if a company invokes and complies with the requirements outlined in Section 37 of the Food and Drugs Act.

Upcoming Changes to the Guidance Document on the Application for International Trade Certificates for Natural Health Products

The current approach to the issuance of these certificates was developed in 2004 to allow industry to continue to export their products while at the same time to come into compliance with the then new regulatory framework for NHPs. Now that over 18, 000 product licences have been issued, representing more than 23, 000 products on the Canadian market, the current approach is no longer relevant and needs to be revised.

Effective April 1, 2010, International Trade Certificates for NHPs Intended for Export Only (Type II certificates) will no longer be issued, as NHPD is unable to attest to the safety, efficacy and quality of products that have not received market authorization. This certificate does not provide valuable information to importing countries and is inconsistent with other international export certification schemes, such as the WHO Certification Scheme. Further, the certificate does not provide assurance to importing countries that exported products can be marketed in Canada or meet Canadian regulations. ITCs intended for products which possess valid market authorization (Type I) and Certificates of GMP Compliance (Type III) attesting to the GMP status of sites will continue to be issued given that they provide valuable information to importing countries.

Process Improvements

In addition to the upcoming change mentioned above, NHPD has developed a new process to streamline the application process for ITCs. As of this winter, the ITC template will be made available on the Health Canada website and applicants who wish to obtain an ITC will have to complete and mail the ITC template. NHPD will review the completed ITC template for accuracy and will sign/stamp it if the information is accurate and complete. Applicants will no longer be required to submit an application which could result in faster turn around time for the issuance of ITCs.

For more information on this new process please contact the Natural Health Products Directorate.