Frequently Asked Questions

 

 

GENERAL QUESTIONS

1. What is the difference between an International Trade Certificate (ITC) and a Certificate of Free Sale (CFS)?  Which one should I purchase?
2. Does CHP Canada issue Certificates of a Pharmaceutical Product (CPP)?
3. Does a Certificate of Free Sale (CFS) or International Trade Certificate (ITC) issued by CHP Canada have an expiration date?
4. Can I obtain an International Trade Certificate (ITC) or Certificate of Free Sale (CFS) in advance of knowing which country we will be exporting our product to?
5. Does CHP Canada provide the service of having certificates legalized?
6. I found an error on my Certificate.  Will CHP Canada re-issue me a new one?
7. I have special instructions/wording/requests regarding my order.  How do I inform CHP Canada using the online system?

PRICING AND PAYMENT PROCESS
1. How much does each certificate cost?

2. Is there a difference in price between a Certificate of Free Sale (CFS) and the International Trade Certificate (ITC)?
3. Do you offer any discounts?
4. What is the pricing for Medical Devices?

INTERNATIONAL TRADE CERTIFICATES

1. What type of International Trade Certificates (ITC) do you issue?
2. Does CHP Canada issue International Trade Certificates for Export Only?
3. Does CHP Canada use the Licensed Natural Health Products Database (LNHPD) to verify the ingredients and amounts that are provided to issue the International Trade Certificate of Natural Health Products?
4. Do the International Trade Certificates (ITC) issued by CHP Canada differ in any way to those issued previously by Health Canada?
5. Who can apply for an International Trade Certificate (ITC)?
6. What are Certificates of GMP Compliance and are they considered International Trade Certificates (ITCs)?
7. What should I expect to receive with my International Trade Certificate (ITC)?
8. If my site license is about to expire, but I have received an extension from NNHPD, can the extended date be listed on the ITC?
9. If I am importing Natural Health Products into Canada for the purpose of export, can I apply for an International Trade Certificate (ITC)?

CERTIFICATES OF FREE SALE
1. Does CHP Canada issue Certificates of Free Sale (CFS) for foods and other products that are not considered health products?
2. I have a number of products that I want included on my Certificate of Free Sale (CFS).  Will you issue individual certificates or are they all included on one certificate?
3. What information do I need to submit to obtain a Certificate of Free Sale (CFS)
4. Do you customize Certificates of Free Sale (CFS) or do you have a standard template?
5. I have a health product that is only manufactured in Canada, but not sold here.  1) Can I obtain an export certificate? and 2) What type of export document would be most appropriate?

6. What type of Medical Devices do you issue Certificates of Free Sales (CFS) for?

REQUIREMENTS FOR CERTIFICATES

SITE LICENCES 

1. What is a Health Canada Site Licence?

2. Is it required that I have a valid Site Licence?

3. What if I do not manufacture, package or label my product, I have a contractor?

PHOTOCOPIES

1. Do you offer photocopies of notarized certificates?

2. What is the value/purpose of an export certificate photocopy?

PERFORMANCE STANDARDS AND ISSUANCE OF CERTIFICATES
1. Does CHP Canada have a performance standard for issuing certificates?
2. I often require certificates even faster than the 10 business day performance standard.  Is it possible to receive it sooner?
3. How will I know that CHP Canada is working on my certificates?  Do I need to follow up?

CERTIFICATE ACCEPTABILITY
1. Does CHP Canada guarantee that my certificates will be accepted?
2. Should I provide feedback to CHP Canada if my certificate is not accepted?
3. Are there Canadian economic sanctions that may restrict international trade to certain countries?


 GENERAL QUESTIONS


1. What is the difference between an International Trade Certificate (ITC) and a Certificate of Free Sale (CFS)?  Which one should I purchase?

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 CHP Canada 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 can NOT be changed or altered under any circumstances. Please ensure you are ordering the correct certficate before purchase. 

A Certificate of Free Sale (CFS) is a product-specific/ingredient-specific document issued by CHP Canada which attests to the product being compliant with Canadian laws and regulations. CHP Canada 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

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).

2. Does CHP Canada issue Certificates of a Pharmaceutical Product (CPP)?

CHP Canada 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

3. Does a Certificate of Free Sale (CFS) or International Trade Certificate (ITC) issued by CHP Canada have an expiration date?

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.  In such circumstances, CHP Canada can include an expiration date on the CFS if it is provided by the customer at the time of purchase in the comments box prior to checkout.  CHP Canada cannot list an expiration date for an ITC.

4. Can I obtain an International Trade Certificate (ITC) or Certificate of Free Sale (CFS) in advance of knowing which country we will be exporting our product to?

CHP Canada requires that the customer provide the name of the country to which the product will be exported to at time of purchase.

5. Does CHP Canada provide the service of having certificates legalized?

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

6. I found an error on my Certificate.  Will CHP Canada re-issue me a new one?

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

7. I have special instructions/wording/requests regarding my order.  How do I inform CHP Canada using the online system?

For this purpose specifically, CHP Canada has added a comments box which will show up during the payment process.  Please use this to communicate any requests as otherwise certificate will be issued as is.


 PRICING AND PAYMENT PROCESS


1. How much does each certificate cost?

All of CHP Canada’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 at a later date 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.

2. Is there a difference in price between a Certificate of Free Sale (CFS) and an International Trade Certificate (ITC)?

Both CFSs and ITCs are the same price for natural health products and OTCs: $199 per product/certificate (+ applicable taxes).  Please see below for the pricing structure for medical devices.

3. Do you offer any discounts?

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.

4. What is the pricing for 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

INTERNATIONAL TRADE CERTIFICATES


1. What type of International Trade Certificates (ITC) do you issue?

CHP Canada issues two 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. 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 CHP Canada is an authorized third-party issuer of these certificates.

2. Does CHP Canada issue International Trade Certificates for Export Only?

Yes, CHP Canada does issue International Trade Certificates for Export Only.  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. Does CHP Canada use the Licensed Natural Health Products Database (LNHPD) to verify the ingredients and amounts that are provided to issue the International Trade Certificate of Natural Health Products?

Yes, CHP Canada verifies all information provided to populate an International Trade Certificate of Natural Health Products by checking the LNHPD.  Please note that the 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.  CHP Canada 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 that CHP Canada 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, CHP Canada will contact the applicant to let them know of the changes prior to issuance of the certificate.

4. Do the International Trade Certificates (ITC) issued by CHP Canada differ in any way to those issued previously by Health Canada?

In order to ensure acceptability by foreign regulators, the ITC forms contain exactly the same information and are formatted in the same style as the ones formerly issued by Health Canada.  These certificates come attached with a cover letter from Health Canada stating that CHP Canada is an authorized third-party issuer of ITCs.

5. Who can apply for an International Trade Certificate (ITC)?

The applicant must be located in Canada.  If the applicant is not the product licence holder or have legal responsbility 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.

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

6. What are Certificates of GMP Compliance and are they considered International Trade Certificates (ITCs)?

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 CHP Canada, come with a cover letter from Health Canada.

7. What should I expect to receive with my International Trade Certificate (ITC)?

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 CHP Canada is an authorized third-party issuer of ITCs.

8. If my site license is about to expire, but I have received an extension from NNHPD, can the extended date be listed on the ITC?

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 CHP Canada, the new date can be included on the ITC.

9. If I am importing Natural Health Products into Canada for the purpose of export, can I apply for an International Trade Certificate (ITC)?

No.  CHP Canada 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 FREE SALE


1. Does CHP Canada issue Certificates of Free Sale (CFS) for foods and other products that are not considered health products?

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

2. I have a number of products that I want included on my Certificate of Free Sale (CFS).  Will you issue individual certificates or are they all included on one certificate?

Please note that CHP Canada’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 CHP Canada’s policy to issue individual Certificates of Free Sales for each product.  **CHP Canada 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, CHP Canada will issue individual CFS's for each of the products purchased and will not re-issue certificates.

3. What information do I need to submit in order to obtain a Certificate of Free Sale (CFS)?

Product Type

Minimum Acceptable evidence to support a CFS

NHP

Site License number + Natural Product Number  (if available)

OTC /Disinfectant

Establishment License number  + Drug Identification Number (if available)

Low-risk veterinary health product

Establishment License number + Notification Number

Medical Devices

Medical Device Establishment License + Medical Device License (if applicable)

Ingredient (in natural health products)

Ensure inclusion on the NHPD Ingredients Database + Natural Product Number or Drug Identification Number (if available) + Site License or Establishment License

4. Do you customize Certificates of Free Sale (CFS) or do you have a standard template?

CHP Canada 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, CHP Canada will try to accomodate requests if they are included in the comments box at the time of purchase.  CHP Canada 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, CHP Canada will issue a standard CFS and will not make additions or revisions after payment is processed.

5. I have a health product that is only manufactured in Canada, but not sold here.  1) Can I obtain an export certificate? and 2) What type of export document would be most appropriate?

CHP Canada can issue a Certificate of Free Sale as long as the site license and/or drug establishment license is provided.  It will clearly be stated on the Certificate that the product is intended for export only.

The other certificate that CHP Canada offers (if your product meets the definition of a natural health product as per the Natural Health Product Regulations) is an Export Only International Trade Certificate.  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.  CHP Canada would require a valid site license and/or drug establishment license number in order to issue such a certificate.

6. What type of Medical Devices do you issue Certificates of Free Sales (CFS) for?

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


 

REQUIREMENTS FOR CERTIFICATES

When ordering an Export Certificate, all required information must be present at time of order. Please make sure you can check the box for each certificate requirement prior to ordering and be prepared to upload content on to your account.

Certificate of Free Sale
(CFS)

International Trade Certificate (ITC)

International Trade Certificate – Export Only
(ITC – Export Only)

Certificate of Good Manufacturing Practices
(GMP)

CFS for Medical Devices

 Product Brand Name in Canada

 Product Name in Export Country


 NPN#, DIN#, Product Licence


Valid HC Site Licence

 Product Brand Name in Canada

 Product Name in Export Country


 NPN#, Product Licence


 Valid HC Site Licence

 Product Brand Name in Canada

 Product Name in Export Country


 NPN#, Product Licence


 Valid HC Site Licence

 Valid HC Site Licence

Product Brand Name in Canada

 Product Name in Export Country


Medical Device Establishment Licence (MDEL)* #,

*Class 1 Devices


 Valid HC MDEL Licence

 

__________________________________________________________________________________

SITE LICENCES

1. What is a Health Canada Site Licence?

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 issues export certificates.  

2. Is it required that I have a valid Site Licence?

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. 

3. What if I do not manufacture, package or label my product, I have a contractor?

No problem. We require a copy of your contractor’s valid Site Licence, and a signed permission letter on the contactors letterhead confirming they are your contractor and consent to see their Site License. 

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

 

__________________________________________________________________________________

PHOTOCOPIES

1. Do you offer photocopies of notarized certificates?

Yes, CHP Canada offers photocopies of our Export Certificates for an added cost.

2. What is the value/purpose of an export certificate photocopy?

The photocopies of certificates are only for internal record keeping purposes. CHP Canada 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.  

 

 PERFORMANCE STANDARDS AND ISSUANCE OF CERTIFICATES


1. Does CHP Canada have a performance standard for issuing certificates?

Yes, CHP Canada has a performance standard of ten (10) business days. 

2. I often require certificates even faster than the 10 business day performance standard.  Is it possible to receive it sooner?

CHP Canada understands that your certificate requests are often critical and urgent.  However, due to our high volume of orders and commitment to ensuring accuracy, we can only commit to our ten (10) business day performance standard. 

3. How will I know that CHP Canada is working on my certificates?  Do I need to follow up?

As soon as CHP Canada receives payment for a certificate order, the 10-day clock begins from that day.  CHP Canada strongly discourages applicants from calling or emailing to receive an update on their order as this can result in delays.  Customers will receive an email informing them when the order is shipped.  **Please note that CHP Canada will no longer send drafts for approval prior to mailing out certificates.


 CERTIFICATE ACCEPTABILITY


1. Does CHP Canada guarantee that my certificates will be accepted?

CHP Canada does not 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.

2. Should I provide feedback to CHP Canada if my certificate is not accepted?

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

3. Are there Canadian economic sanctions that may restrict international trade to certain countries?

Yes there are and it is the responsibility of the applicant to ensure that they are in compliance 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 

 
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