Guidance for Industry on Third-Party Issuance of International Trade Certificates
An International Trade Certificate (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. Given the significant number of NHPs exported abroad, the ITC was developed to help facilitate access to Canadian-made NHPs in foreign markets.
There are 3 types of ITCs:
- NHP with product licence (NPN) and site licence
- NHP with product licence (DIN-HM) and site licence (for homeopathic medicines)
- NHP site licence only
Although the issuance of ITCs is not required under the Natural Health Products Regulations (NHPR), Health Canada voluntarily issued them, upon request, as a service to industry and this impacted processing time.
From June 1, 2013, to August 29, 2013, Health Canada consulted on, and piloted, a new approach to ITC issuance designed to better meet industry demand. Under this approach, third-parties issue ITCs. Health Canada received very minimal feedback through the ITC consultation. The pilot was evaluated on an ongoing basis throughout the consultation period. Feedback received supported the feasibility of the approach.
Third-Party Issuance of ITCs
As of September 2, 2013, Health Canada is transferring the responsibility of ITC issuance to independent third-parties.
Third parties who want to issue ITCs for NHPs are requested to attest to Health Canada that they meet the criteria listed below. To ensure transparency for both regulatees and international regulators, Health Canada requests that each ITC issuing body make publicly available a statement outlining how they meet each of the criteria.
Health Canada will not be managing a publicly available list of third-parties who have attested to these criteria. To find a third-party who has attested, please contact your industry association.
As of September 2, 2013, Health Canada will not be accepting any new ITC applications. However, all ITC applications in queue as of September 2, 2013, will be processed by March 31, 2014. As specific timelines cannot be provided for the processing time, companies are encouraged to submit requests to third-party issuers if they have an immediate need for the certificate.
How Does a Third-Party Become an Issuer of ITCs?
Criteria for Self-Attestation
Disclaimer: Health Canada will not be responsible for complaints resolution
- Policies, procedures and standards: The 3rd party should possess and make publicly available in both official languages, the policies, procedures and standards it uses to ensure that the ITCs are readily available to industry.
- Expertise: The 3rd party should possess the knowledge, skills and competencies required to successfully:
- issue the certificates - this includes:
- the review of product and site licensing status of NHPs available on Health Canada's website;
- monitoring of changes in the licensing status of products and sites; and
- determining an acceptable period of validity of the ITC for foreign regulatory bodies.
- have the capacity to issue ITCs in both English and French;
- have performance evaluation measures to ensure timely issuance of the ITCs;
- review, evaluate and adjudicate complaints regarding the ITCs; and
- have ITCs notarized by a Notary Public or a Commissioner of Oaths.
- issue the certificates - this includes:
- Corporate Relations: The 3rd party should possess mechanisms to ensure timely communication with applicants when required.
- Conflict of Interest: The 3rd party should not have any conflict of interest. The 3rd party should not be a party regulated by Health Canada under the Natural Health Products Regulations (e.g., a manufacturer). Industry associations, composed of regulated parties, who act as 3rd party issuers should ensure no one member has issuing authority.
Notifying Health Canada
Third parties should advise Health Canada in writing that they attest to meeting all the Health Canada criteria by submitting their name and contact information to the Director General of the Natural Health Products Directorate, Health Canada.
Third parties are responsible for notifying Health Canada of any changes in contact information and/or their ability to attest to these criteria.
Health Canada will not be managing a publicly available list of third parties who have attested to these criteria. Third parties may wish to provide with ITCs, the cover letter that Health Canada will issue when a third-party attests. The letter states that the issuer attests to the Health Canada criteria.
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