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Found 10 records similar to Natural Health Product (NHP) Compounding Policy
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.
The NHP MAP outlines the process applied by NNHPD to manage Product Licence Applications (PLA) for Natural Health Products (NHPs) submitted in accordance with the Natural Health Products Regulations (NHPR). The policy also outlines the responsibilities and expectations of NHP applicants throughout the application process.
Today (2021/06/25), in an effort to better support Canadians in their use of these products, Health Canada announced proposed changes to the Natural Health Products Regulations to make NHP labels more clear, legible and easier to understand.
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.
In Canada, natural health products (NHP's) fall under the Natural Health Products Regulations of the Food and Drugs Act. These Regulations came into effect on January 1, 2004. Several guidance documents have been created to provide industry with clear guidelines on how to comply with the Regulations.
This guidance document pertains to Part 3 of the Natural Health Product Regulations (the Regulations) and is intended for manufacturers, packagers, labellers, importers, and distributors of natural health products (NHPs) for sale in Canada.
More Canadians are using natural health products (NHPs). Health Canada has developed new regulations that will help ensure that natural health products are well prepared, safe to use, effective and come with instructions on how they are to be used.
In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its associated regulations. Products that meet the definition of a "natural health product" (NHP) as set out in the Natural Health Products Regulations (NHPR) are subject to the FDA as it applies to drugs and to the NHPR. Products that are foods as defined in the FDA are subject to the FDA as it applies to foods and to Parts A, B and D of the Food and Drug Regulations (FDR). It is important to note that the provisions of the FDR do not apply to products classified as NHPs except where such provisions are incorporated by reference into the NHPR, as per section 3 of the NHPR.
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.
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).