Good manufacturing practices COMPLIANCE ProducT Licence APplication to Obtain Natural Product Number (NPN) Site Licensing Services & APplications ADVERSE REACTION ReportING
Specific licences are required to manufacture and market NHPs for sale in Canada. Manufacturers, packager, labellers, importers must have a site licence. Those who wish to market an NHP for sale in Canada must have a product licence. 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 licence types for Canada.
All NHPs must receive a product licence prior to being marketed for sale in Canada. A Product Licence 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 licence and an eight-digit Natural Product Number (NPN), or a Homeopathic Medicine Number (DIN-HM) to be displayed on the label.
All Canadian companies who manufacture, package, label, or import NHPs must possess site licences. 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.
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 licence applications by risk, from Class I (low risk) to Class III (high risk). As such, the information required when applying for an NHP licence will vary in complexity between product types. CannDelta will guide you every step of the way through the licensing process.
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 licenced Canadian importer in order to export NHPs into Canada.
Founded in 2018, CannDelta has been assisting with licensure, regulatory compliance, facility suitability, design, physical security, process-flow, standard operating procedures (SOPs), and operations support to ensure efficiency in Canada, the United States, and the World. Natural health products and the alternative medicine industry is booming as more people recognize the positive health benefits of naturally sourced ingredients. Our experts help your company define your products as safe, regulated, and pure. When it comes to natural health products, we want to be as transparent in our process as you are in your ingredients. Trust those that know best. Message CannDelta today about getting started with your Natural Health Product business today!