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Found 10 records similar to Natural Health Products Management of Applications Policy
The Health Products and Food Branch (HPFB) commits to issue a product licensing decision within the service delivery standards outlined in: Service standards for the management of Product Licence Applications (PLA) for Natural Health Products (NHP).
This policy outlines Health Canada's current approach with respect to compounding of NHPs. The NHP Compounding Policy distinguishes between the manufacturing of natural health products, an activity regulated by the Natural Health Products Regulations (NHP Regulations), and the compounding of natural health products, an activity unregulated by NHP Regulations.
Companies must hold a site licence to manufacture, package, label or import natural health products (NHPs) in Canada. When doing these activities, companies must follow good manufacturing practices requirements (NHP GMPs) in the Natural Health Product Regulations (NHPR). It is a company’s responsibility to comply with the applicable regulatory requirements. When we identify an issue, we take compliance and enforcement actions based on several factors such as the risk to your health.
This guidance document provides information to help product licence applicants determine the evidence (type and amount of data) to provide as part of a product licence application to support the safety (risk) and efficacy (benefit) of natural health products (NHPs) that make modern health claims.
The Natural Health Products (NHP) Online System is a suite of secure web applications and tools that you can use to fill your NHP licence application.
The Natural Health Products Regulations (NHP Regulations) do not specify whether raw materials are or are not included in the definition of a natural health product (NHP). The NHP definition mentions neither raw material (e.g., ginger root that has just been harvested) nor finished product (e.g., encapsulated ginger that is packaged and labelled for the consumer). The NHP Raw Material Policy clarifies at which point a material becomes an NHP, and therefore when product and site licensing requirements are triggered.
Learn about the risks of buying natural health products (NHPs) online and how to identify licensed products.
The Amendment and Notification Form (ANF) is the exclusive form to be used for submitting post licensing changes for a licensed natural health product (NHP) to the Natural and Non-prescription Health Products Directorate (NNHPD).
The purpose of this Policy is to further describe to regulated parties the compliance approach outlined in the Inspectorate's Compliance and Enforcement Policy (POL-0001) as it relates to NHPs to support a transparent, consistent and predictable compliance and enforcement approach.
Health Canada assesses NHPs for their safety, effectiveness and quality before they are authorized for sale in Canada. NHPs that have been licensed by Health Canada are labelled with either a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM). Despite this licensing process, it is still possible to get unauthorized NHPs through retail stores or other routes (like the Internet and/or importing them from other countries).