Consultation – Message to Natural Health Product Stakeholders regarding the issuance of International Trade Certificates

The Natural Health Products Directorate (NHPD) is seeking your feedback on the issuance of International Trade Certificates (ITCs).

An ITC is a document which speaks to the regulatory status of a natural health product (NHP) in Canada and/or the Canadian manufacturing, packaging, and/or labeling site.

The NHPD voluntarily issues these certificates as a service to regulatees. However, the Directorate is proposing an approach whereby ITCs would be issued by independent 3^rd parties.

The NHPD has developed criteria which 3^rd parties should attest to prior to beginning to issue ITCs. The NHPD has also developed a cover letter which will be made available to a 3^rd party attesting to meeting the proposed criteria. This cover letter, which would be attached to ITCs, will serve to inform foreign regulatory authorities that a 3rd party has attested to Health Canada's criteria for ITC issuance.

Next Steps

During the 90-day consultation period beginning on May 31^st, 2013, ITCs will be issued by three organizations which have attested to meeting Health Canada's criteria.

The  Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA), the  Canadian Health Food Association (CHFA), and  Consumer Health Products Canada (CHP Canada) will be piloting the revised approach and issuing ITCs. Please contact them directly regarding the issuance of ITCs.

Health Canada will issue ITCs for requests that were made prior to June 1, 2013. While the Department will continue to process requests after that date, stakeholders are encouraged to submit requests to one of the piloting organizations. ITCs are not required under the Natural Health Products Regulations; rather, NHPD voluntarily issues them upon request as a service to industry and this impacts the processing time.

Once the consultation is closed and the approach is finalized, additional organizations wishing to attest to Health Canada's criteria would be able to do so. However, Health Canada will not be managing a publicly available list of third parties who have attested to these criteria.

All comments received during this consultation process will be considered prior to finalizing the revised approach.

How to get involved in the Consultation Process

This consultation is open for comment starting May 31^st, 2013 to August 28, 2013.

Please submit your comments via email, fax or by mail to:

• Email: nhpd_consultations_dpsn@hc-sc.gc.ca
• Fax: 613-957-8341
• Natural Health Products Directorate
  Health Canada
  Qualicum Tower A
  International Trade Certificates Consultation
  Address Locator 3301D
  2936 Baseline Road
  Ottawa Ontario
  K1A 0K9