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Natural Health Products Licensing

Natural Health Products Site Licenses and Support

Natural Health Products

Since 2004, all-natural health products sold in Canada have been subject to the Natural Health Products Regulations. Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) regulates NHPs and non-prescription drugs in Canada.A ‘Natural Health Product’ (or “NHP”) refers to a range of products that are used to prevent or treat a condition, to reduce health risks, or to maintain good health. Unlike prescription drugs, NHPs are sold as over-the-counter products for consumer use. Common NHPs include vitamins, workout supplements, plant & herbal remedies, traditional & homeopathic medicines, and certain non-prescription drugs & disinfectants.

 

Our Vision

To Lead Our Clients Confidently

CannDelta wants to build world-leading strategies with companies working in the natural health product industry. From legalization to large-scale research and development, CannDelta works with industry experts to achieve a better, more profitable future for the regulated and scientific community worldwide.

Since 2004, all natural health products sold in Canada are subject to the Natural Health Products Regulations. Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) is the regulating authority for NHPs and non-prescription drugs in Canada. 

What are Natural Health Products ?

A ‘Natural Health Product’ (or “NHP”) refers to a range of products that are used to prevent or treat a condition, to reduce health risks, or to maintain good health. Unlike prescription drugs, NHPs are sold as over-the-counter products for consumer use. Common NHPs include vitamins, workout supplements, plant & herbal remedies, traditional & homeopathic medicines, and certain non-prescription drugs & disinfectants. 

CannDelta’s NHP Services Include:

Product and Site Licensing 

Specific licenses are required to manufacture and market NHPs for sale in Canada. Manufacturers, packager, labellers, importers must have a site license. Those who wish to market an NHP for sale in Canada must have a product license. To obtain a product and/or site licence, you must comply with specific labelling and packaging requirements, procedures, good manufacturing practices (GMPs), and provide adequate safety and efficacy evidence in support of your product(s). CannDelta completes applications for all NHP license types for Canada.

Product License Applications

All NHPs must receive a product licence prior to being marketed for sale in Canada. A product license application (PLA) must be submitted for each product. A PLA includes detailed information relating to the product’s use, medicinal & non-medicinal ingredients, dosage, potency, and claims. If the product is determined to be safe, effective, and compliant with regulations, Health Canada will issue a product license and an eight-digit Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) to be displayed on the label.

Product Licensing Pathways 

There exist four kinds of product licence submissions: Compendial, Traditional, Non-traditional, and Homeopathic. Each product submission type relates to the nature of the product, proposed claims, risks, and supporting scientific, traditional, or homeopathic evidence. Health Canada further classifies natural health product license applications by risk, from Class I (low risk) to Class III (high risk). As such, the information required when applying for an NHP license will vary in complexity between product types. CannDelta will guide you every step of the way through the licensing process. 

Site License Applications

All Canadian companies who manufacture, package, label, or import NHPs must possess site licenses. To obtain a site licence, facilities must adhere to specific requirements. They must demonstrate good manufacturing practices (GMPs), maintain proper distribution records, implement standard operating procedures (SOPs) for product recalls, and establish procedures for the handling, storage and delivery of their products. 

Foreign Site Reference Number (FSRN) Applications

Manufacturers located outside of Canada who wish to manufacture, package, label, or export NHPs into Canada must obtain a Foreign Site Reference Number (FSRN). To obtain an FSRN, individual sites must be assessed by Health Canada against Part 3 of the Natural Health Products Regulations (NHPR) for Good Manufacturing Practices (GMPs). Once approved by Health Canada, FSRN holders must form a partnership with a licensed Canadian importer in order to export NHPs into Canada. 

Natural Health Products Licensing Services

  • Natural Health Product Site Licences
  • Natural Health Product Licensing
  • Supplier Qualification
  • Import/Export
  • Reporting for Adverse Reactions

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