By: William Morkel, BSc
Director of Quality & Compliance

It is standard practice amongst many countries to require an International Trade Certificate (ITC) to accompany any natural health product (NHP) imported into their jurisdiction. In recognition of this, Health Canada began issuing trade certificates for NHPs when the Regulations were first implemented.

Currently, the Natural Health Products Directorate (NHPD) issues two types of Trade Certificates as they pertain to NHPs:

• An ITC for NHPs – This speaks specifically to products. Any product that holds a valid NPN or DIN-HM can obtain an ITC. Bear in mind that a separate application must be submitted for each product and country of destination.
• An ITC of Good Manufacturing Practices (GMP) Compliance – This speaks specifically to domestic Canadian sites that possess a valid Site Licence. It is site, and not product specific and is essentially an attestation that a facility has been evaluated and found to comply with the Canadian NHP GMP.

There are, however, a few caveats concerning ITCs of which the industry should be aware. First, the NHPD will not issue ITCs for products that only hold an EN, even though these products can be legally sold in Canada. Mind you, given that UPLAR is scheduled to expire in February 2013, this point is somewhat academic since all ENs will have become obsolete by that date.

Second, because assessment of compliance with GMP is currently based on a paper review and not on an actual onsite audit, not all jurisdictions will accept the ITC for GMP Compliance as issued by Health Canada. The NHPD recognizes this and cites it as one of the points in favour of conducting future on-site audits. When such inspections will commence remains to be seen, but the NHPD has been actively developing the framework for a new site licencing model that involves onsite inspections of domestic and foreign facilities.

Third, because it is a complimentary service, the NHPD does not obligate themselves to meeting any time lines and it is not uncommon for companies to wait several months before receiving their trade certificates. Nevertheless, the NHPD does recognize the delays and has said (at least verbally) that they are committed to shortening their turnaround times.

In a further development, the NHPD has recently communicated to certain trade organizations, including the Direct Sellers Association (DSA) and the Canadian Health Food Association (CHFA), that they are in the process of assessing different models for issuing ITCs, including using the services of a 3^rd party. The 3^rd party approach would definitely have its benefits, in so far as history shows that an outside administrator can often process requests in a quicker and more efficient manner. Bear in mind, however, that this will likely mean that industry will have to pay a fee for a service that is currently free.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or at dicentra.com