Obtaining an NPN number for your product can be complex and time-consuming. Still, it’s essential for ensuring compliance with Canadian regulations. Here are the steps you’ll need to follow to obtain an NPN number:
Step 1: Determine if your product requires an NPN number
Not all NHPs require an NPN number. Health Canada defines an NHP as “a substance set out in Schedule 1, a combination of substances set out in Schedule 1, or a homeopathic medicine.” If your product does not fall under this definition, it may not require an NPN number. However, it’s always best to check with Health Canada to confirm whether your product requires an NPN number.
Step 2: Submit a product license application to Health Canada
You must submit a product license application to Health Canada for an NPN number. This application will include your product’s ingredients, dosage form, recommended use, and any health claims you wish to make. You’ll also need to provide evidence to support your product’s safety, efficacy, and quality. This evidence may include clinical trial data, scientific studies, and manufacturing information.
Step 3: Wait for Health Canada to review your application
Once you’ve submitted your product license application, you must wait for Health Canada to review it. The review process can take several months, depending on the complexity of your application and the workload of Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD). Health Canada may ask for additional information or clarification about your product during the review process.
Step 4: Receive your NPN number
You’ll receive an NPN number from Health Canada if your product license application is approved. This number will be specific to your product. It must be included on the label of all packages of your product sold in Canada. You’ll also receive a product license, which must be kept on file at your place of business and made available to Health Canada upon request.