Natural Health Product NPN License Registration

In order to sell natural health products or dietary supplements in Canada, it is required that the manufacturers obtain a Natural Product Number (NPN) which is called product license.

In License Supports (LS), we help our clients:

File NPN license application.
Prepare all necessary documentation for application submission.
Submit the request to Health Canada.
Manage all pre-post approval communications & activities.
Post-License modifications support.
Amendments and Notifications

We offer a complete solution so you can legally obtain NPN for your NHP and sell in Canada. This includes licensing your health product and ensuring your label meets language (English and French) and label regulations.

"Regulatory considerations are of the greatest importance when bringing a product into the market for sale! "

How obtain a natural product license (NPN) from the Natural

How we help:

Application review and preparation:
- We review the product’s formula and determine which route of administration match the product (Class I/Class II/Class III).
- We review ingredient specifications to ensure that their safety and efficacy are supported.
- We ensure the mandatory information is declared in full and accurately reflects product.
- We prepare a regulatory label that contains the necessary information for the product’s marketing and sale.
- We assist clients find supporting documents, such as clinical studies, to support the safety and efficacy of the ingredients not supported by Health Canada.
- We ask clients send us the formulations.
- We require the official brand name of the product, Dosage directions and dosage form, the amounts of each medicinal ingredient (with the source materials) and the non-medicinal ingredients, the ratio for extracts.
- We review the documents and evaluate the product is a candidate for licencing.
- We create quotation. After approval by client, the next step will be followed:
- Health Canada Designated Party Authorization (DPA) Form should be signed by client. This form authorise us to submit applications on behalf of client to Health Canada.
- Then application package will be prepared and submitted to Health Canada.

APPLICATION REQUIREMENTS

The name, contact information of the company that will own the product licence (NPN).
The type & class of application.
Any associated manufacturers, packagers, labellers, importers.
For each medicinal ingredient, the common name, source, quantity, potency/ratio.
The name of each non-medicinal ingredient.
The dosage form.
Directions of use.
Claims.
Proposed cautions.

Proposed Label Content:

A proposed label is required.

Finished Product Specifications:

Finished Product Specification form should be submitted, specifying the required tests (potency, micro, heavy metals, etc.), limits, test methods.

Efficacy and Safety Documentation

Literature is required to be submitted to support the efficacy of all claims & the safety of the product according to the directions of use.

Find out more

Experienced Food and Natural Health Product Consultant

Natural Health Product NPN License Registration

How obtain a natural product license (NPN) from the Natural

How we help:

APPLICATION REQUIREMENTS

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