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Frequently Asked Questions
Browse the most frequently asked questions about our certificates below!
Before You Register
No. Unfortunately, we cannot offer shipping to other countries. All orders must be shipped to a Canadian Address.
We can only issue international trade certificates and certificated of free sale for the following products:
- Natural health products (NHPs)
- Over-the-Counter products (OTCs)
- Disinfectant
- Medical devices
- Low-risk veterinary health products
All of FHCP’s certificates are $199 per product/certificate (+ applicable taxes). This includes the cost of issuing the certificate, notarizing the certificate and express mailing the package to you.
We also offer a Bulk Discount of a 50% discount when you order 10 certificates or more in one order. The bulk discount rate is applicable for any combination of certificates as long as the number of certificates purchased within one order is ten or more. **The bulk discount rate is not applicable over the span of different orders. (If ordering 10 or more certificates, the discount will be applied. Please note that when it is in your cart, the discount will not show up until payment stage.)
*Medical Devices: Depending on the type of medical device, prices for Certificates of Free Sale vary. Please see the table below prior to making your purchase.
| Medical Device Type | Price (+ applicable taxes) |
| Class I | $199 |
| System | $199 for all device names listed on license |
| Test Kits | $199 for all device names listed on license |
| Medical Device Family Group of medical devices made by the same manufacturer, that differ in only shape, colour, flavour or size, that have the same design and manufacturing process, and have the same intended use. Products can be sold individually, and therefore we charge per product/per certificate. |
$199 per device name listed on license |
| Medical Device Group Device groups are devices that are listed and packaged together to meet a specific purpose. All Device Names listed under the license are composed of a collection of medical devices, such as a procedure pack or tray that is labelled and sold under a single name. Devices licensed in a medical device group cannot be sold outside the group- as such we list all products listed in a device group under one certificate. |
$199 for all device names listed on license |
| Medical Device Group Family Collection of medical device groups that are made by the same manufacturer, have the same generic name specifying their intended use, and differ only in the number and combination of products that comprise each group. |
$199 per device name listed on license |
| Single Medical Device | $199 per device name |
Please note: Our certificates are per product per country, one time use per shipment (ie. the notarized certificate must be enclosed with each shipment). That said, you can only order one certificate per country. If you have more than one importing country, you must buy more than one certificate.
We have added a comments box, which can be used during check out. Please use this comment box to communicate any requests (otherwise certificate will be issued as ordered).
Yes. All International Trade Certificates (ITCs) and Certificates of Free Sale (CFSs) issued by FHCP come notarized. We also the convenience service of offering Global Affairs Canada authentication services should this be required.
No. All certificates are issued per product, per country. FHCP requires that the customer provide the name of the country to which the product will be exported to at time of purchase.
Export Certificates do not expire. Our notary public will verify every certificate, and the notarization stamp is only valid for 3 years from the date of issue.
FHCP does not issue Certificates of Pharmaceutical Product (CPP). A CPP is a document issued by Health Canada’s Health Products and Food Branch Inspectorate (HPFBI) that establishes
the status of the pharmaceutical, biological, radiopharmaceutical or veterinary product listed and the good manufacturing practice (GMP) status of the fabricator of the product. If you are interested in obtaining a CPP, click here for more information: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0024_doc-eng.php
An International Trade Certificate (ITC) is a document that Health Canada used to issue, which speaks to the regulatory status of a natural health product in Canada and/or the Canadian manufacturing, packaging and/or labelling site of such products. Please note that FHCP only issues International Trade Certificates for natural health products. ITCs are not issued for any other type of product.
*Please note- The wording of the ITC document CANNOT be changed or altered under any circumstances. Please ensure with the foreign regulator and/or client that you are ordering the correct certificate before purchase.
A Certificate of Free Sale (CFS) is a product-specific/ingredient-specific document issued by FHCP, which attests to the product being compliant and freely sold with Canadian laws and regulations.
The applicant must be located in Canada. If the applicant is not 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.
Certificate Acceptability
Yes, there are and it is the responsibility of the applicant to ensure that they comply with any Canadian and/or international trade laws (i.e. sanctions against Iran). Please find more information on Canadian Economic Sanctions here: http://www.international.gc.ca/sanctions/index.aspx?lang=eng&menu_id=1&view=d
Yes, please provide this information to FHCP’s Trade Certificate Program Coordinator. This information will be conveyed to Health Canada.
FHCP cannot guarantee the acceptability of certificates by foreign regulators and/or border service authorities. The applicant is responsible for talking to the foreign regulator/border authorities prior to ordering certificates to determine if they accept export certificates and if so, what type of information needs to be provided.
Certificate Information
Yes, you can only obtain a “International Trade Certificate (ITC) Export Only” (if your product meets the definition of a natural health product as per the Natural Health Product Regulations). These certificates are only for products that would fall under the definition of a natural health product in Canada, but are not sold in Canada (and therefore do not have an NPN). They come with a cover letter stating that the product has been manufactured for the purposes of export only. FHCP would require a valid site license and/or drug establishment license number in order to issue such a certificate.
Please note: Unfortunately, Certificates of Free Sale or regular International Trade Certificates are not available without an NPN/DIN.
No. FHCP 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 Product Regulations and possess pre-market authorization in the form of a valid NPN or a DIN-HM.
If formal documentation from Health Canada (i.e. letter/fax/email) stating that the company has been granted an extension as to the validity of their site license is provided to FHCP, the new date can be included on the ITC.
Along with receiving a signed and notarized Export Certificate (International Trade Certificate or Certificate of Free Sale), you will also receive a cover letter issued by Health Canada (ITC) or FHCP (CFS) stating that FHCP is an authorized third-party issuer of ITCs.
- Regular Certificate of Free Sale: A Certificate of Free Sale (CFS) is a product-specific/ingredient-specific document issued by FHCP, which attests to the product being compliant and freely sold with Canadian laws and regulations. This certificate includes the product name in Canada, the country of import, and its Health Canada registration information.
- Certificate of Free Sale Plus (Ingredients): CFS+ is a new type of certificate of free sale is being offered that includes further details about a product on the normal Certificate of Free Sale. New information includes: Ingredients, dosage form, route of administration, and exporter information.
FHCP issues three types of ITCs:
- International Trade Certificates of Natural Health Products – issued for natural health products that have a natural product number (NPN) or drug identification number for homeopathic medicines (DIN-HM) and are manufactured, labelled and packaged in sites that hold a valid site license.
- International Trade Certificate (Export Only) – Yes, FHCP does issue International Trade Certificates for Export Only. Export Only ITCs are only available for products that are manufactured in Canada but are not sold in Canada. These certificates can only be issued for products that: 1) would be considered a natural health product and 2) are not sold in Canada (i.e. they are manufactured in Canada for the sole purpose of export).**Please note that since Health Canada stopped issuing these certificates, they do not come with a cover letter from Health Canada, unlike the International Trade Certificates of Natural Health Products and Certificates of GMP Compliance noted in question #1 above.
- Certificates of GMP Compliance – contains information on the site license holder, site information, site license number and the date of site license expiry. The country of export does not need to be provided to obtain this type of certificate since it does not list it.
Both of these certificates come notarized, along with a cover letter from Health Canada stating that FHCP is an authorized third-party issuer of these certificates.
Common Questions
We can only issue international trade certificates and certificated of free sale for the following products:
-
- Natural health products (NHPs)
- Over-the-Counter products (OTCs)
- Disinfectant
- Medical devices
- Low-risk veterinary health products
No. Unfortunately, we cannot offer shipping to other countries. All orders must be shipped to a Canadian Address.
All of FHCP’s certificates are $199 per product/certificate (+ applicable taxes). This includes the cost of issuing the certificate, notarizing the certificate and express mailing the package to you.
We also offer a Bulk Discount of a 50% discount when you order 10 certificates or more in one order. The bulk discount rate is applicable for any combination of certificates as long as the number of certificates purchased within one order is ten or more. **The bulk discount rate is not applicable over the span of different orders. (If ordering 10 or more certificates, the discount will be applied. Please note that when it is in your cart, the discount will not show up until payment stage.)
*Medical Devices: Depending on the type of medical device, prices for Certificates of Free Sale vary. Please see the table below prior to making your purchase.
| Medical Device Type | Price (+ applicable taxes) |
| Class I | $199 |
| System | $199 for all device names listed on license |
| Test Kits | $199 for all device names listed on license |
| Medical Device Family Group of medical devices made by the same manufacturer, that differ in only shape, colour, flavour or size, that have the same design and manufacturing process, and have the same intended use. Products can be sold individually, and therefore we charge per product/per certificate. |
$199 per device name listed on license |
| Medical Device Group Device groups are devices that are listed and packaged together to meet a specific purpose. All Device Names listed under the license are composed of a collection of medical devices, such as a procedure pack or tray that is labelled and sold under a single name. Devices licensed in a medical device group cannot be sold outside the group- as such we list all products listed in a device group under one certificate. |
$199 for all device names listed on license |
| Medical Device Group Family Collection of medical device groups that are made by the same manufacturer, have the same generic name specifying their intended use, and differ only in the number and combination of products that comprise each group. |
$199 per device name listed on license |
| Single Medical Device | $199 per device name |
Please note: Our certificates are per product per country, one time use per shipment (ie. the notarized certificate must be enclosed with each shipment). That said, you can only order one certificate per country. If you have more than one importing country, you must buy more than one certificate.
We have added a comments box, which can be used during check out. Please use this comment box to communicate any requests (otherwise certificate will be issued as ordered).
Yes. All International Trade Certificates (ITCs) and Certificates of Free Sale (CFSs) issued by FHCP come notarized. We also the convenience service of offering Global Affairs Canada authentication services should this be required.
No. All certificates are issued per product, per country. FHCP requires that the customer provide the name of the country to which the product will be exported to at time of purchase.
Export Certificates do not expire. Our notary public will verify every certificate, and the notarization stamp is only valid for 3 years from the date of issue.
FHCP does not issue Certificates of Pharmaceutical Product (CPP). A CPP is a document issued by Health Canada’s Health Products and Food Branch Inspectorate (HPFBI) that establishes
the status of the pharmaceutical, biological, radiopharmaceutical or veterinary product listed and the good manufacturing practice (GMP) status of the fabricator of the product. If you are interested in obtaining a CPP, click here for more information: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/licences/directives/gui-0024_doc-eng.php
An International Trade Certificate (ITC) is a document that Health Canada used to issue, which speaks to the regulatory status of a natural health product in Canada and/or the Canadian manufacturing, packaging and/or labelling site of such products. Please note that FHCP only issues International Trade Certificates for natural health products. ITCs are not issued for any other type of product.
*Please note- The wording of the ITC document CANNOT be changed or altered under any circumstances. Please ensure with the foreign regulator and/or client that you are ordering the correct certificate before purchase.
A Certificate of Free Sale (CFS) is a product-specific/ingredient-specific document issued by FHCP, which attests to the product being compliant and freely sold with Canadian laws and regulations.
The applicant must be located in Canada. If the applicant is not 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.
Free Personalized Draft
After you have reviewed your draft and are happy with the certificate, enter back to the cart page and click the “Checkout” button.
Simply remove that product from your cart, by clicking the “Delete” button. Return to “My Sites/Facilities” or “My Products” page, click the “Edit” button next to your site or product and make the desired changes. Then click on the product you wish to purchase “CFS, ITC-EX, ITC-NHP or ITC-GMP” and add to your cart again.
Yes. However, these drafts are not to be copied or reproduced. They are also not valid until signed and notarized. It is illegal to forge, or represent an unsigned or invalidated certificate as valid.
Yes, you can download a copy of your draft certificate by entering the “Cart” page and clicking on the “download draft” button. Under each product added to your cart there is a “download draft” button. You can click on this button and a draft version of your certificate will pop up in another tab on your browser. If this does not open when you click download draft, ensure your pop-up blocker is temporarily disabled.
Yes, in the “Cart”, there is a button labelled “download draft”. Click on the “download draft” and it will open in a new tab.
Global Affairs Canada Authentication
Yes, the regular standard of 8-10 business days is extended to allow for the GAC legalization. It requires 7 additional business days to fulfill a GAC legalization per order, moving the performance standard to 15-17 business days. If you order a rush certificate your GAC and rush will amount to 10 business days total.
The Global Affairs Canada (GAC) Legalization is $125 for up to 10 certificates. For example if you order one GAC legalization add-on, it will cost $125. However, but if you order 10 or less GAC legalization add-ons it will still cost only $125.
Yes. In addition to our notarized Export Certificates, customers have the option to add Global Affairs Canada Legalization to their certificate for an added charge.
Performance Standards
Yes, FHCP offers 3 day rush service. You can add this premium add on service at checkout.
Yes, FHCP has a performance standard of ten (10)-business days. However, a rush order is 3 business days!
Photocopies
The photocopies of certificates are only for internal record keeping purposes. FHCP Export Certificate Photocopies are NOT for exporting or distributing purposes. They are solely intended for internal record keeping or receipt of purchase. They come as a colour photocopies, however they do not show the embossed notary stamp and they come with a clearly labeled “COPY” stamp.
Yes, FHCP offers photocopies of our Export Certificates for an added cost.
Site Information
No problem. We require a copy of your contract manufacturer’s valid Site License, and a signed permission letter on the contact manufacturer’s letterhead confirming they are your contractor and consent to see their Site License.
Also, if you are procuring an export certificate for a client, we will also require a permission letter for use of the NPN/DIN stating that they have given you permission to obtain certificates for those products they have licensed.
TEMPLATE FOR CONTRACT MANUFACTURER/PACKAGER/LABELLER:
| To be printed on (Site Licence Holder) company letterhead
Date: Subject: Permission to list site license To whom it may concern: (Site Licence Holder Company Name), located at (address) (Site License #: ______) confirms that they manufacture, package and label (your company name)’s natural health products.
Signed by (Licence Holder Company Name), Representative |
TEMPLATE FOR NPN/ DIN Permission:
| To be printed on (NPN/DIN Licence Holder) company letterhead
Date: Subject: Permission to use NPN/DIN To whom it may concern: (Licence Holder Company Name), located at (address) (NPN/DIN #: ______) confirms that they give permission for (your company name)to obtain an export certificate for their product(s).
Signed by (Licence Holder Company Name), Representative |
Yes. You MUST have a valid Health Canada Site Licence. It is mandatory for us to verify and issue your export certificate. This applies to CFS, ITC- NHP, ITC- Export Only, and GMP Certificates. If the site license has been renewed, please provide us with a PDF copy.
Health Canada Issues a variation of GMP (Good Manufacturing Practices) Compliance in a document entitled a Site Licence. Site Licences are used to verify and issue export certificates.
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