A Natural Product Number (NPN) is an 8-digit number issued to a Natural Health Product (NHP), after an assessment, indicating its approval by Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) to be sold in the Canadian market. In this article, we will delve into the different types of NPNs, the Product Licence Application (PLA) process, and the steps to obtain an NPN for your product.
Types of NPNs
There are 2 main types of NPNs, assigned according to the characteristics of the NHP.
NPN
- Natural Product Numbers (NPNs) are assigned to Natural Health Products (NHPs)(with the exception of homeopathic medicines).
- Examples include products with herbal ingredients, vitamins, minerals, amino acids, and other natural substances (or duplicates thereof).
- Suitable for products not meeting the homeopathic medicine definition.
DIN-HM
- Drug Identification Number – Homeopathic Medicine (DIN-HMs) Numbers are assigned to homeopathic medicines.
- Homeopathic medicines, while having similar requirements to NHPs, do have their own unique standards of evidence, specific Good Manufacturing Practices (GMP), and contain substances that are not otherwise regulated under the NHP regulations.
- A DIN-HM is required for products classified as homeopathic medicines.
Obtaining an NPN
To obtain an NPN, you must file a Product Licence Application (PLA) with the NNHPD. The PLA is the pre-market approval pathway for NHPs in Canada, encompassing NPNs, and Drug Identification Number-Homeopathic Medicine (DIN-HM), etc., for relevant products.
Classes of PLAs
There are three classes of PLAs:
Class I
- All medicinal ingredients present completely attest to a single NNHPD Monograph to support the product’s safety and efficacy.
- Shortest expected NNHPD performance-standard review time of 60 days.
Class II
- All medicinal ingredients present are attesting to multiple NNHPD Monographs to support the product’s safety and efficacy.
- Medium-length NNHPD performance standard target of 90 days for review.
Class III
- There is at least one medicinal ingredient present that is not supported by NNHPD Monographs.
- Independent external evidence is required to be submitted with the NHP application to support the non-monograph ingredient’s safety (and if necessary, efficacy).
- Longest NNHPD performance standard review time of 180 days (+30 days administration; being 210 days in total).
Important Steps to obtaining an NPN from Health Canada:
- Determine if your product requires an NPN. For example, some products such as cosmetics and personal care products, don’t require an NPN. However, if you want to make a health-benefit claim on that product’s labels, an NPN will likely be necessary.
- Compile the documents required to determine the relevant safety, efficacy, and quality data for your medicinal ingredients.
- Identify which class of NHP your product licence application will be filed under.
- Substantiate any health claims on labelling or advertising with adequate evidence.
- Confirm compliance with Good Manufacturing Practices for Natural Health Products (NHP-GMPs) for manufacturers.
- Establish an NHP site licence for domestic manufacturing facilities or ensure an importer of record holds a valid site license for foreign manufacturers.
- Prepare the PLA through the Web-based PLA-form.
- Review your product labelling (based on what was prepared on the PLA for regulatory compliance.
- Submit on Canada Post’s electronic ePost system the PLA along with any necessary external references and copy of the product label.
Navigating the regulatory landscape for NHPs in Canada requires a thorough understanding of NPNs and the PLA process. With the diverse classes and specific requirements, obtaining an NPN demands meticulous attention to detail. As you embark on this journey, please seek guidance and support to ensure a smooth and successful application process.
For personalized assistance and further guidance on obtaining an NPN for your natural health product, please reach out to our experienced team. Contact us today to explore the tailor-made solutions we offer in navigating the regulatory pathways and securing approval for your product in the Canadian market.
