Frequently Asked Questions

We can only issue international trade certificates and certificated of free sale for the following products:

1. 1. Natural health products (NHPs)
   2. Over-the-Counter products (OTCs)
   3. Disinfectant
   4. Medical devices
   5. Low-risk veterinary health products

We can only issue international trade certificates and certificated of free sale for the following products:

1. Natural health products (NHPs)
2. Over-the-Counter products (OTCs)
3. Disinfectant
4. Medical devices
5. Low-risk veterinary health products

FHCP issues three types of ITCs:

1. 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.
2. 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.

3. 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.

• 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.

Unfortunately, we do not issue Export Certificates (ITC or CFS) for foods or other products (i.e. cosmetics) that are not considered health products

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.

Yes, FHCP has a performance standard of ten (10)-business days. However, a rush order is 3 business days!

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.

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

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.

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.

Yes, FHCP offers 3 day rush service. You can add this premium add on service at checkout.

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.

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).

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.

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.

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What is a natural health product?

Natural health products (NHPs) are defined in the Natural Health Products Regulations as vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as Traditional Chinese Medicines, probiotics, and other products like amino acids and essential fatty acids.

Under the Regulations, the product must be safe for consideration as a nonprescription product. Natural health products are available for self-care and self-selection, and do not require a prescription to be sold. Products requiring a prescription will continue to be regulated under the Food and Drug Regulations.

How does a natural health product get to market?

In order to market your products in Canada, the Natural Health Products Regulations first require you to obtain the necessary product and site licenses¹.

Product Licensing

Before any natural health product can be sold in Canada, it must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality¹. Evidence demonstrating this must be submitted to Health Canada by means of a product license application (one for each product). Products, which meet the required criteria, will be authorized for sale and issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM). Further information on this process is available in the Product Licensing Guidance Document (see Product Licensing).

¹ NOTE: On August 4, 2010, Health Canada implemented a new regulation to manage a situation whereby a resource problem has led to a large number of natural health products being in backlog to be reviewed. The Natural Health Products (Unprocessed Product License Applications) Regulations will provide a temporary exemption (and number beginning with “EN”) to permit NHPs, for which a product license application has been filed with Health Canada, but the assessment has not been completed, to be legally sold on the market. The exemption number will stay in effect until the application(s) is withdrawn or is processed and a decision to issue or refuse a license is made. These regulations will be repealed 30 months after coming into force (ie., February 2013).

Site Licensing

The Natural Health Products Regulations require any Canadian site where natural health products are manufactured, imported, labeled, packaged, distributed, and/or stored to have a site license. Businesses can choose to have a single site license for all their operations (i.e. multiple sites) or an individual license for each site. Site licenses are obtained by demonstrating that the above-mentioned activities are conducted in a manner that is congruent with the requirements of the Canadian Good Manufacturing Practices (GMPs) for NHPs. Further information is available in the Site License Guidance Document (see Site Licensing).

Currently there are no costs or fees associated with the submission and review of product and site license applications.

How does a natural health product get approved for import into Canada?

Canadian importers must have a site license and the onus is on them to provide evidence that imported products come from sites that meet the Canadian Good Manufacturing Practices (GMPs), or equivalent standards. The Canadian importer is responsible for submitting a Quality Assurance Report for each site (foreign and domestic) with their site licence application. The importer must ensure that these reports are complete and that all requirements of the GMPs are being met. Site licenses are only issued to Canadian sites (none are issued to foreign sites). Foreign manufacturers will be covered under the Canadian importer’s site license.

Further information on the importation of natural health products is outlined in Section 5 of the Site License Guidance Document.

All products, whether manufactured domestically or in a foreign site, must first undergo a pre-market review where it will be assessed for safety, efficacy, and quality. Evidence demonstrating this must be submitted to Health Canada by means of a product license application (one for each product). Products, which meet the required criteria, will be authorized for sale and each issued a Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM)1. Further information on his process is available in the Product Licensing Guidance Document.

How can Canadians know a product has been approved for sale by Health Canada?

Once assessed by Health Canada, the product label will bear an 8-digit product license number, preceded by the letters “NPN”. The NPN on the label will inform the public that the product has been reviewed by Health Canada for safety, quality, efficacy and health claims. For homeopathic medicines, the label will bear the designation DIN-HM. Products that have received an NPN are listed in Health Canada’s Licensed NHP Database.

If the product has a license number beginning with “EN”, it means a submission for review has been made to Health Canada, but it has not yet been reviewed. These products are legal to be sold in Canada while their submission is pending review. Products that have received an EN are listed in Health Canada’s NHP Exempted Products Database.

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What is an over-the-counter (OTC) medication?

Over-the-counter medications (also referred to as “nonprescription medications”) are a subset of drugs, and drugs are defined in the Food and Drugs Act as including any substance or mixture of substances manufactured, sold or represented for use in:

• the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
• restoring, correcting or modifying organic functions in human beings or animals, or
• disinfection in premises in which food is manufactured, prepared or kept.

Over-the-counter medications are used for the prevention, treatment, symptomatic relief, cure or risk reduction of diseases, injuries or chronic conditions that individuals can recognize and manage on their own behalf, either separately or in participation with professionals. Over-the-counter medications are regulated by the Food and Drug Regulations.

How does an over-the-counter medication get to market?

Product Licensing

In order to market an over-the-counter medication in Canada, the product must receive a Drug Identification Number (DIN) from Health Canada.

Before an over-the-counter medication can be marketed in Canada, it must undergo pre-market review by Health Canada’s Therapeutic Products Directorate where it will be assessed for safety, efficacy and quality. Evidence demonstrating this must be contained in a Drug Application form. Medicines that meet the required criteria will be authorized for sale and issued a DIN.

Submission fees are applicable for the registration and review of over-the-counter medications and must be paid upon filing of the application. Fees vary depending on the type of submission filed (see Form).

DIN owners are required to renew the DINs on their products on an annual basis (Authority to Sell Drug Fees apply).

Establishment Licenses

The Health Products and Food Branch Inspectorate ensures the uniform, efficient, and effective enforcement of the requirement for all Canadian drug establishments and any foreign drug establishments providing drug products to the Canadian market, to comply with the Food and Drug Regulations. Canadian drug establishments must hold an establishment license to fabricate, package, label, distribute, import, wholesale, or test a drug in Canada. (Forms and instructions)

Establishment licenses must be renewed annually. Fees for the licenses reflect the cost of the Health Products and Food Branch Inspectorate activity required to inspect an establishment based on the type of facility and the scope and extent of activity, which will in turn be based on risk management principles.

How can Canadians know a product has been approved for sale by Health Canada?

Once assessed by Health Canada, the product label will bear an 8-digit drug identification number, preceded by the letters “DIN”. The DIN on the label will inform the public that the product has been reviewed by Health Canada for safety, efficacy, health claims and quality.

Yes, in the “Cart”, there is a button labelled “download draft”. Click on the “download draft” and it will open in a new tab.

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. 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.

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.

After you have reviewed your draft and are happy with the certificate, enter back to the cart page and click the “Checkout” button.

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.

Yes, please provide this information to FHCP’s Trade Certificate Program Coordinator. This information will be conveyed to Health Canada.

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, FHCP offers photocopies of our Export Certificates for an added cost.

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.

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.

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.

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:

TEMPLATE FOR NPN/ DIN Permission:

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.

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, 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.

At this time, FHCP does not issue Certificates of Free Sale (CFS) for foods or other products (i.e. cosmetics) that are not considered health products.

Please note that FHCP’s pricing structure is such that the cost per certificate is per product, per country (i.e. if you are looking to purchase a Certificates of Free Sale (CFS) for five products all for the same country, you will be charged for five products). It is FHCP’s policy to issue individual Certificates of Free Sales for each product.

**FHCP recognizes that some foreign regulators prefer all products to be included on one certificate. If this is the case, please do the following: Purchase individual CFS’s for each of the products and before payment, include a request in the comments box to issue one CFS for the products you have purchased (please do so by specifying the name of each product).

** Please note that if this request is not included in the comments box, FHCP will issue individual CFS’s for each of the products purchased and will not re-issue certificates.

Yes, FHCP verifies all information provided to populate an International Trade Certificate of Natural Health Products by checking the LNHPD.

**License holder is responsible for ensuring that the information posted on the LNHPD is correct. If the license holder finds mistakes related to the product license on the LNHPD, the license holder should contact Health Canada directly. FHCP is not responsible for any inaccuracies that may be found on the LNHPD and will only attest to the information provided on the LNHPD.  Please note, there have been several instances where the LNHPD has been incorrect, please ensure to provide FHCP with the most updated product license.

**Please note that FHCP reserves the right to make any changes to the information an applicant submits on an ITC template if the information contradicts the LNHPD. In such cases, FHCP will contact the applicant to let them know of the changes prior to issuance of the certificate.

Yes. FHCP has developed a standard Certificate of Free Sale (CFS) template, which includes the following: product name, license number, country of import and the site/establishment license details recognizing that certain foreign regulators request specific wording, FHCP will try to accommodate requests if they are included in the comments box at the time of purchase. FHCP will review the requested wording and will determine if it can be included.

**Please note: if this request is not included in the comments box at the time of purchase, FHCP will issue a standard CFS and will not make additions or revisions after payment is processed.

FHCP issues CFSs for Class I, II, III and IV medical devices. FHCP does not issue CFSs for export-only medical devices or those exempt from Section V of the Medical Device Regulations.

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.

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.

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.

No. ITC forms contain exactly the same information and are formatted in the same style as the ones formerly issued by Health Canada.  We have chosen to keep our ITC template consistent with that Health Canada used to ensure that our certificates continue to be recognized and accepted by foreign authorities.  These certificates come attached with a cover letter from Health Canada stating that FHCP is an authorized third-party issuer of ITCs.

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.

**Please note: For Certificates of GMP Compliance, only the site license holder may request this certificate.

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.

Certificates of GMP Compliance contain information regarding the site license holder, as well as where natural health products are manufactured, labelled and packaged.  They also list the date of expiry for the site license and the site license number.  These documents are considered to be ITCs, although titled otherwise, and when issued by FHCP, come with a cover letter from Health Canada.

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.

Along with receiving a signed and notarized International Trade Certificate (ITC) for your product, you will also receive a cover letter issued by Health Canada stating that FHCP is an authorized third-party issuer of ITCs.

Yes. FHCP is pleased to offer our new service of 3 day rush processing.

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. FHCP issues Certificates of Free Sale for the following types of health products:

1. Natural health products (NHPs)
2. Over-the-Counter products (OTCs)
3. Disinfectant
4. Medical devices
5. Low-risk veterinary health products
6. Ingredient (in natural health products)

In the case of a natural health product, it is best to discuss with the foreign regulator as to which type of certificate they will accept (i.e. ITC or CFS).

Rush processing will be offered at 3 business days from the date of order, shipped via FedEx priority overnight. If you order a Global Affairs Canada Authentication this adds the 7 Business days on top of the 3 rush business days. 

3-day rush processing costs $100 per certificate.

*If there is a high demand, rush processing may not always be available, please check-ordering site for details.

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

No expiration date is listed on either a Certificate of Free Sale or International Trade Certificate.  In certain cases, foreign regulators insist that an expiration date be listed on a Certificate of Free Sale.

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.

Yes. All International Trade Certificates (ITCs) and Certificates of Free Sale (CFSs) issued by FHCP come notarized.  Any further authentication or legalization requirements that may need to be met are the responsibility of the applicant.

No. It is the applicant’s responsibility to ensure that the information entered is accurate and there are no typos or grammatical mistakes. FHCP will not re-issue new certificates if errors are found post-purchase.

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.

**Please note that certificates requested for the same product and same country later will be subject to the $199 (+ applicable taxes) fee or $99 (+ applicable taxes) if the bulk discount rate is applicable..

Certificates of Free Sales (CFS) for medical devices are subject to different prices dependent on the type.  Please see below for the pricing structure.

FHCP has added a comments box, which can be used during purchase.  Please use this comment box to communicate any requests (otherwise certificate will be issued as ordered).

No. Unfortunately, FHCP cannot offer shipping to other countries.  All orders must be shipped to a Canadian Address.

No. Both CFSs and ITCs are the same price $199 per product/certificate (+ applicable taxes).  Please see below for the pricing structure for medical devices.

Yes, we offer a bulk discount.  If you are purchasing ten (10) or more certificates at a time, you are eligible for our bulk discount of $99/product/certificate (+ applicable taxes).  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.)

Depending on the type of medical device, prices for Certificates of Free Sale vary.  Please see the table below prior to making your purchase.