Foreign Site Reference Number (FSRN) for Canada: A Complete Guide

Foreign Site Reference Number (FSRN) for Canada: A Complete Guide

When foreign facilities manufacture, package, or label Natural Health Products (NHPs) for the Canadian market, Health Canada requires proof that these sites meet Good Manufacturing Practices (GMPs). To simplify this process, the Natural and Non-prescription Health Products Directorate (NNHPD) issues a Foreign Site Reference Number (FSRN).   An FSRN acts as…
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Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

Health Canada’s 2025 Update to the GMP Guide (GUI-0158) for Natural Health Products – What’s New in Version 4.0 and How to Comply

Adhering to good manufacturing practices (GMP) is a cornerstone of regulatory compliance for companies in the natural health product (NHP) industry. In Canada, GMP requirements are outlined in Health Canada’s Good manufacturing practices guide for natural health products (GUI-0158), which supports Part 3 of the Natural Health Products Regulations. The…
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NHP Site Licensing Made Simple for Canadian Market

NHP Site Licensing Made Simple for Canadian Market

In Canada, any business that manufactures, packages, labels, or imports natural health products (NHPs) must hold a valid site licence obtained from Health Canada. This licence confirms that the company complies with the requirements set out in the Natural Health Products Regulations and Site Licensing Guidance Document, including adherence to…
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