Regulatory Open Forum

Hello -

I am working with a dietary supplement importer who is looking to expand into the Canadian market. I can find all of the Health Canada information on the website about product listing, site registration, etc., but cannot find the forms. Can anyone help me source those? Also any thoughts on whether a Trading Partner Profile is worth the hassle to file electronically?

Thank you!

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Marc Sanchez
Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
FDA Atty Law Firm (CIHCC, LLC)
Washington, D.C.
United States
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Hi Marc,

Not sure if this is what you were looking for: http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodnatur/form_sl-dle-eng.pdf

which is based on this: Site Licensing Guidance Document

http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/slgd-drle-eng.php

Hope that helps,

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Clarisa Tate
Medical Device, RA & QA
Bay Area, CA
USA

Original Message:
Sent: 30-Jun-2016 12:13
From: Marc Sanchez
Subject: Health Canada Natural Health Product Listing - Forms?

Hello -

I am working with a dietary supplement importer who is looking to expand into the Canadian market. I can find all of the Health Canada information on the website about product listing, site registration, etc., but cannot find the forms. Can anyone help me source those? Also any thoughts on whether a Trading Partner Profile is worth the hassle to file electronically?

Thank you!

------------------------------
Marc Sanchez
Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
FDA Atty Law Firm (CIHCC, LLC)
Washington, D.C.
United States
------------------------------

Hello,

The linked provided is the Site Licensing Form.  In Canada, you need both a product licence and site licence to sell a natural health product (NHP) in Canada.  Here's a link to the electronic product licence application form:  http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/online-enligne/pla-dlmm-view-eng.php   There is a paper-based form as well, but it should only be used in rare circumstances that do not work with the electronic form.  The electronic form links up to the Natural Health Products Ingredient Database so it helps assure your medicinal ingredients are NHPs and your non-medicinal ingredients are permitted to a certain extent.

I recently resigned after an 11 year career with the Natural and Non-Prescription Health Products Directorate for Health Canada.  I know this area of the Canadian Regulations very well, if you have any questions or require assistance filing your product or site licences please send me an email (asalisbury@TPIreg.com).  I do recommend you file electronically as it will speed up your approval, which my firm is registered as a Trading Partner.  I can say with absolutely certainty that electronic applications will receive their approval faster, as it's faster on the inside to manage and review. 

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Angie Salisbury RAC
Associate Director, Canadian Healthcare and Medical Devices
Therapeutic Products Inc
1269 Centre Road
Hamilton, ON, CANADA L8N 2Z7
Cell: 613-253-2281

Original Message:
Sent: 30-Jun-2016 12:13
From: Marc Sanchez
Subject: Health Canada Natural Health Product Listing - Forms?

Hello -

I am working with a dietary supplement importer who is looking to expand into the Canadian market. I can find all of the Health Canada information on the website about product listing, site registration, etc., but cannot find the forms. Can anyone help me source those? Also any thoughts on whether a Trading Partner Profile is worth the hassle to file electronically?

Thank you!

------------------------------
Marc Sanchez
Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
FDA Atty Law Firm (CIHCC, LLC)
Washington, D.C.
United States
------------------------------

Hi Marc,

I'm not sure whether you're still looking. Clarisa is right, but there's a few more forms you'll need. This link should give you all the forms you need to apply for the Site License:  

Site Licensing Forms

This includes:

Site License Application Form

Quality Assurance Report Form

Supplementary QAR Form (if the product is a homeopatic)

Creating a TPP would be worth it for Product License submissions and good to have for site licence applications. 

Let me know if you have further questions on the application itself.

All the best!

Worlanyo

------------------------------
Worlanyo Sosu-Sedzorme RAC
Regulatory & Quality Manager
Genomedx Biosciences
San Diego CA
United States

Original Message:
Sent: 30-Jun-2016 12:13
From: Marc Sanchez
Subject: Health Canada Natural Health Product Listing - Forms?

Hello -

I am working with a dietary supplement importer who is looking to expand into the Canadian market. I can find all of the Health Canada information on the website about product listing, site registration, etc., but cannot find the forms. Can anyone help me source those? Also any thoughts on whether a Trading Partner Profile is worth the hassle to file electronically?

Thank you!

------------------------------
Marc Sanchez
Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
FDA Atty Law Firm (CIHCC, LLC)
Washington, D.C.
United States
------------------------------

Marc,

I forgot to attach the link for the Product Licensing Forms. Here you go!

Product Licensing Forms and Templates

Cheers

Worlanyo

------------------------------
Worlanyo Sosu-Sedzorme RAC
Regulatory & Quality Manager
Genomedx Biosciences
San Diego CA
United States

Original Message:
Sent: 30-Jun-2016 12:13
From: Marc Sanchez
Subject: Health Canada Natural Health Product Listing - Forms?

Hello -

I am working with a dietary supplement importer who is looking to expand into the Canadian market. I can find all of the Health Canada information on the website about product listing, site registration, etc., but cannot find the forms. Can anyone help me source those? Also any thoughts on whether a Trading Partner Profile is worth the hassle to file electronically?

Thank you!

------------------------------
Marc Sanchez
Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
FDA Atty Law Firm (CIHCC, LLC)
Washington, D.C.
United States
------------------------------

Hello Marc,

To be able to file a successful product license application, you must also include the Canadian site which will be importing it. Site Licenses are issued only to Canadian sites. If the product manufacturer is in the US, it must acquire a Foreign Site Reference Number as well. 

See the link which explains the process and links to forms.  Site Licensing Guidance Document

 Cheers,

------------------------------
Betheny Moore Roberts
Regulatory Affairs Manager
Bernardston MA
United States

Original Message:
Sent: 30-Jun-2016 12:13
From: Marc Sanchez
Subject: Health Canada Natural Health Product Listing - Forms?

Hello -

I am working with a dietary supplement importer who is looking to expand into the Canadian market. I can find all of the Health Canada information on the website about product listing, site registration, etc., but cannot find the forms. Can anyone help me source those? Also any thoughts on whether a Trading Partner Profile is worth the hassle to file electronically?

Thank you!

------------------------------
Marc Sanchez
Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
FDA Atty Law Firm (CIHCC, LLC)
Washington, D.C.
United States
------------------------------

Thank you all for the wonderful tips and links. This is very helpful!

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Marc Sanchez
Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
FDA Atty Law Firm (CIHCC, LLC)
Charlotte NC
United States

Original Message:
Sent: 30-Jun-2016 12:13
From: Marc Sanchez
Subject: Health Canada Natural Health Product Listing - Forms?

Hello -

I am working with a dietary supplement importer who is looking to expand into the Canadian market. I can find all of the Health Canada information on the website about product listing, site registration, etc., but cannot find the forms. Can anyone help me source those? Also any thoughts on whether a Trading Partner Profile is worth the hassle to file electronically?

Thank you!

------------------------------
Marc Sanchez
Regulatory (FDA/USDA) Attorney and Consultant/Adjunct Professor
FDA Atty Law Firm (CIHCC, LLC)
Washington, D.C.
United States
------------------------------