Frequently Asked Questions Concerning International Trade Certificates Under the Natural Health Products Regulations

Questions:

1. What is a Natural Health Product International Trade Certificate?
2. Do I require a certificate to export a natural health product from Canada?
3. Does issuance of an international trade certificate indicate Health Canada's approval of a product?
4. Who can apply for an International Trade Certificate?
5. What is the difference between an Export Certificate completed under Section 37 of the Food and Drug Act and an NHP International Trade Certificate?
6. What is the difference between an NHP International Trade Certificate and a Certificate of Pharmaceutical Product (CPP)?
7. How is the Certificate of GMP Compliance different from the NHP International Trade Certificate?
8. Should I discontinue using the Canadian Food Inspections Agency's Manufacturer's Declaration and apply for the NHP International Trade Certificate?
9. If I invoke Section 37 of the Food and Drugs Act, do I also need to apply for a NHP International Trade Certificate for NHPs for Export Only?
10. If I am importing Natural Health Products into Canada for the purpose of export, can I apply for an NHP International Trade Certificate?
11. How long will it take to receive my NHP International Trade Certificate, after the application is submitted?
12. Are there fees that apply to the application for an NHP International Trade Certificate?
13. Am I required to show regulators in destination countries that the natural health product is approved for sale in Canada?
14. Our company exports to two or three countries, can this be covered on one International Trade Certificate?
15. What is required to obtain an NHP International Trade Certificate? Is there only one type of International Trade Certificate application?
16. How do I apply for an NHP International Trade Certificate?
17. Whom do I contact for further information?

Answers:

1. What is a Natural Health Product International Trade Certificate?
A certificate which speaks to the regulatory and marketing status of the natural health product in Canada, but is not a guarantee of a product's safety or quality.

2. Do I require a certificate to export a natural health product from Canada?
No. This certificate is not required under the Natural Health Products Regulations. The Natural Health Products Directorate voluntarily issues these certificates to facilitate the export process for Canadian manufacturers as a service to industry, when requested.

3. Does issuance of an international trade certificate indicate Health Canada's approval of a product?
No. An international trade certificate contains information on the regulatory and marketing status of the product in Canada. The issuance of a certificate does not suggest or imply that Health Canada approves or sanctions any specific product. It is the responsibility of the product licence holder to market a safe and properly labelled product.

In order to market a natural health product in Canada, the product must be compliant with the Natural Health Products Regulations. All natural health products in Canada require pre-market authorization in the form of a valid NPN or DIN-HM and must be manufactured, packaged and labelled in licensed facilities.

4. Who can apply for an International Trade Certificate?
The applicant must be located in Canada. If the applicant is not also the product licence holder or have legal responsibility for the product, a letter from the product licence holder or person / company with legal responsibility for the product authorizing the applicant to export the product must accompany the application.

5. What is the difference between an Export Certificate completed under Section 37 of the Food and Drug Act and an NHP International Trade Certificate?

The Export Certificate under Section 37 of the Food and Drugs Act is a certificate signed by the manufacturer and a Commissioner for Taking Oaths to attest that the product for which the certificate is prepared is not manufactured or sold for Canadian consumption and its package and the contents do not contravene any known requirement of the law of the country for which it is or is about to be consigned.

The NHP International Trade Certificate is issued by the Natural Health Products Directorate of Health Canada, upon submission of an application package including information on the regulatory status of the product in Canada. An international trade certificate speaks to the regulatory and marketing status of the natural health product in Canada.

6. What is the difference between an NHP International Trade Certificate and a Certificate of Pharmaceutical Product (CPP)?
A CPP is a certificate based on the WHO format, which is issued by the Health Products and Food Branch Inspectorate, for pharmaceutical, biological or radiopharmaceutical products.

The NHP International Trade Certificate is issued for those products classified as natural health products under the Natural Health Products Regulations.

7. How is the Certificate of GMP Compliance different from the NHP International Trade Certificate?
The Certificate of GMP Compliance is issued for a site located in Canada with a valid site licence issued under the Natural Health Products Regulations. It is not product specific, but speaks to the regulatory and compliance status of the specified site(s) authorized to conduct the following activities with respect to natural health products: manufacturing, packaging, labelling or importing.

The NHP International Trade Certificate is a product specific certificate which speaks to the regulatory and marketing status in Canada of the specified product.

8. Should I discontinue using the Canadian Food Inspections Agency's Manufacturer's Declaration and apply for the NHP International Trade Certificate?
This depends on the product(s) you are exporting. CFIA will continue to issue the Manufacturer's Declaration document to those products which meet the food definition in the Food and Drugs Act. Those products which meet the definition of an NHP according to the Natural Health Products Regulations will need to apply for the NHP International Trade Certificate.

To sell a natural health product in Canada, NHPs must be fully compliant with the Natural Health Products Regulations and possess pre-market authorization in the form of a valid NPN or DIN-HM.

9. If I invoke Section 37 of the Food and Drugs Act, do I also need to apply for a NHP International Trade Certificate for NHPs for Export Only?
This is the manufacturer's choice. An export certificate in the format described under Section 37 of the Food and Drugs Act will satisfy Health Canada that the specified product(s) does not fall under the purview of the Natural Health Products Regulations. The NHP International Trade Certificate may facilitate the entry of natural health products in other countries, by providing information to foreign regulatory authorities on the regulatory and marketing status of the product in Canada.

10. If I am importing Natural Health Products into Canada for the purpose of export, can I apply for an NHP International Trade Certificate?
No. The Natural Health Products Directorate does not issue certificates for products that are imported for the purposes of export only. Natural Health Products that are imported into Canada for the purposes of sale in Canada must be fully compliant with the Natural Health Products Regulations and possess pre-market authorization in the form of a valid NPN or DIN-HM.

11. How long will it take to receive my NHP International Trade Certificate, after the application is submitted?
As this is done on a voluntary basis, NHPD does not commit to any specific time frame. However, we will make every effort to process these applications in a timely manner. You will receive your certificate as soon as your application has been reviewed.

12. Are there fees that apply to the application for an NHP International Trade Certificate?
No. The Natural Health Products Directorate does not currently charge for the issuance of these certificates. However, it is anticipated that a fee system will be developed for these certificates in the near future.

Applicants must include a completed shipping form (waybill Purolator, Fedex, Loomis, UPS, Dicom, etc.) with each request.

13. Am I required to show regulators in destination countries that the natural health product is approved for sale in Canada?
It is up the country of destination as to what they require before a product enters their country. Exporters are encouraged to contact the consulate or regulatory authority for the country of destination for information on the requirements for import.

14. Our company exports to two or three countries, can this be covered on one International Trade Certificate?
No. A certificate is country specific, naming one individual country as the country of destination.

15. What is required to obtain an NHP International Trade Certificate? Is there only one type of International Trade Certificate application?
There are three different types of applications. The following is required for each:

1. NHP ITC for NHPs with marketing authorization: a valid product licence and site licence(s);
2. NHP ITC for NHPs for Export Only: Products must be manufactured, packaged and labelled for export only and the manufacturer and the ITC applicant must retain a copy of the completed Section 37 Export Certificate in their files for each product; and
3. Certificate of GMP Compliance: a valid site licence.

16. How do I apply for an NHP International Trade Certificate?
You can download the application form and instructions from the Natural Health Products or you can order a paper copy by email at nhp_applications_psn@hc-sc.gc.ca. Applications must be submitted by mail to the following address:

Submission Management Division
Qualicum Tower A
2936 Baseline Rd.
AL 3302B
Ottawa, Ontario
K1A 0K9
(for courier K2H 1B3)

Applicants must include a completed shipping form (waybill Purolator, Fedex, Loomis, UPS, Dicom, etc.) with each request.

17. Whom do I contact for further information?
You can contact the Natural Health Products Directorate submission information line by email at: nhp_applications_psn@hc-sc.gc.ca.