Steps to Obtaining a Natural Product Licence

Steps to Obtaining a Natural Product Licence

We have simplified the process of completing a natural product licence application and obtaining a natural product license from the Natural Health Products Directorate (NHPD) into seven steps.

Step 1:

First we sign a non-disclosure agreement with you (ours or yours), assuring you that anything we discuss remains strictly confidential. Eventually some of the information will need to be included on the application submitted to Health Canada but they are the only people outside of ourselves to which anything will be disclosed.

Step 2:

We would then have you send us the formulations that you wish to have licensed by Health Canada. In order to assess the formula and provide a quote we will require the following information:

  • The official brand name of the product;
  • Dosage directions and dosage form;
  • The formula with the amounts of each medicinal ingredient and the non-medicinal ingredients. Please include the source materials (ie. leaf, root) for your medicinal ingredients.
  • For extracts, please ensure that they have a ratio (e.g. 4:1), and for standardized extracts, please ensure they have constituents and potencies.

Step 3:

We will review the documents and let you know if the product is a candidate for licencing in its present form or if some small changes would make it acceptable. The changes could be as simple as doubling the dose or adding / subtracting an ingredient. If the product cannot comply with Canadian regulations, we will advise you that there is little or no chance of success. Please note there is no charge for this regulatory evaluation and discussions of registration feasibility.

Step 4:

Once this basic review is completed, we will send you an all-inclusive, comprehensive written quotation for the work required. There are no hidden or additional charges. What we quote is all that you will pay.

Step 5:

If the quote is acceptable, we will send you a Health Canada document to sign known as a Designated Party Authorization (DPA) Form. This form gives us permission to submit applications and speak on your behalf to Health Canada.

Step 6:

Once the application is submitted to Health Canada we will issue an invoice to you, which will be the same as the quote, and ask that it be honoured upon receipt.

Step 7:

Once the Natural Product Number (NPN) has been granted, we will complete a label compliance review. Since Canada is a bi-lingual country certain regulatory label text must be in French, such as directions of use, recommended use/purpose, risk statement, etc. Therefore we will translate the required regulatory label text into French.