A product licence is required for the  sale of  Natural Health Products(NHPs) in Canada unless you are a retailer. You are  not allowed to sell a natural Health product without a product licence even if you claim its doctor formulated as I have seen lately.

If the licence is cancelled or suspended, you are not allowed to sell any product related to that licence.
Before you can apply for a product licence you must know the different pathways for licensing natural health products and the evidence required by Natural and Non-prescription Health Products Directorate to support safety quality and efficacy. The next step is to select the pathway that is suitable for your product. The third step is to assemble the information required in the application.

The product licence application involves filling an application form. This form captures important information based on the regulations. Consultations may be required.

Initially you will be required to provide information about the applicant for the Natural Health Products  licence. You will then be asked to provide your Canadian address and the business name, address and telephone number, and the fax number and e-mail address of the applicant.

If you don’t have a Canadian address, you will be required to find a Canadian representative but you must still provide your own contact information. You will be required to provide the name, address and telephone number, and the fax number and  e-mail address of your representative in Canada

The next most important component of your licence is the medicinal ingredients. It is generally accepted that a natural health product may consist of more than one medicinal ingredient. Certain information about each medicinal ingredient must be provided.

Medicinal  Ingredients and the  Natural Health Products Ingredients Database

For consistency in the product licence application you should provide the proper name and the common name of each medicinal ingredient. These ingredients must exist in the Natural Health Products Ingredients Database. Some ingredients in the database are not Natural Health Products.

You will need to spend some time at the Natural and Non-prescription Health Products Directorate website to determine the proper names and common names as the rules for naming are not uniform.

By the time you are applying for product licence, you already know the dosage form. You should be able to provide the quantity of each medicinal ingredient in each dosage unit such as a tablet or a capsule

If there is a claim for potency on the label, you should provide information about it. You are required to provide potency only if your medicinal ingredient includes standardized preparation. Potency captures the concentration of a medicinal an active or marker constituent of an ingredient.

The source of your medicinal ingredient should be described as this can delay your product licence application review.
You should also provide a statement whether any medicinal ingredient was synthetically manufactured or extracted. This information is required as some potential users may be sensitive to contaminants from its source.

Non medicinal ingredients

Non medicinal ingredients are very important in the manufacture of the dose form. They should be provided in the product licence application. You should provide a qualitative list of the non-medicinal ingredients you propose to be in the Natural Health Products. You should also provide a statement about the purpose of each ingredient. You must ensure that these ingredients are in the Natural Health Products Ingredients Database as your application may be rejected on this account.

Brand Name

To distinguish your Natural Health Products from the others in the market place, you should provide a brand name. This is the name under which you propose to sell the Natural Health Products.

Conditions of  Use must be Carefully Assessed Before You  Apply

Natural Health Products are used for self selection and do not require a prescription. You should therefore provide the conditions which must exist for a person to use that Natural Health product. A product licence for a natural health product to treat diabetes or cancer will be rejected as these are Schedule A diseases. This is one of the areas importers overlook resulting in delays.

Safety and efficacy are a Major Requirement in Product Licence applications

This refers to the information that supports the safety and efficacy of your the natural health product. This evidence may be in form of references, monographs or results from clinical trials. The available information will determine the pathway for submission and the review time.

Provide well prepared labeling information

The purpose of labeling is to inform the buyer r about the origin, cost, quantity, specifications how and how to use the products. This information helps the buyer either to buy or not. You should provide the proper text for each label which you propose to be used along with the Natural Health Products. The label will be reviewed by Natural and Non-prescription Health Products Directorate very carefully. You should therefore take your time and care in preparing the label.

Don’t Prepare Specifications at the last moment

You should also provide a copy of the specifications . These will be the specifications  which the natural health product will be expected to comply with. The attestations attestations described below will also be required. These must be prepared carefully according to the guidance documents.

Who should provide attestations?

Depending on whether the product licence you seek is for imported or non-imported products you will need to provide an attestation. If you are importing the natural health product, you should provide an attestation that the natural health product  manufacturing, packaging, labelling, importation, distribution  and storage is in accordance with the GMP requirements of natural health products or equivalent.

If the natural health product for which you are seeking a product licence is not imported, you also need to provide an attestation that the natural health product  manufacturing, packaging, labelling, distribution and storage are in accordance with GMP requirements of natural health products or equivalent standard.

This summary should help you to get started . If you need help with the application contact us.