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Found 10 records similar to 2018-2019 Compliance monitoring project: Good manufacturing practices for natural health products
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.
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.
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.
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.
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).
Learn about the risks of buying natural health products (NHPs) online and how to identify licensed products.
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.
Companies that use unacceptable quality standards may be subject to enforcement action. Our main goal is to protect the health and safety of the public.
This guidance document is designed to assist organizations and individuals in applying for authorization to conduct a clinical trial for a natural health product (NHP) in Canada .