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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Why a QAP for NHPs Is Essential for GMP Compliance in Canada 

Why a QAP for NHPs Is Essential for GMP Compliance in Canada 

In the Canadian natural health product (NHP) industry, Good Manufacturing Practices (GMP) are not only a regulatory requirement but also a fundamental part of ensuring consumer safety, product quality, and trust. At the heart of GMP compliance is the Quality Assurance Person for NHPs (QAP). This individual is critical in…
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How to Get a Drug Identification Number (DIN) in Canada — A Guide for Importers and Manufacturers 

How to Get a Drug Identification Number (DIN) in Canada — A Guide for Importers and Manufacturers 

Entering the Canadian pharmaceutical market requires more than just a good product—it requires regulatory approval. If you’re planning to sell prescription drugs, over-the-counter medications, medicated shampoos, or sunscreens in Canada, you’ll need a Drug Identification Number (DIN) issued by Health Canada.  The DIN is not just a tracking number; it’s…
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GMP Regulations for Natural Health Products (NHPs) | Overview and Compliance in Canada 

GMP Regulations for Natural Health Products (NHPs) | Overview and Compliance in Canada 

What are GMPs for NHPs?Quality Assurance Person (QAP) in the GMP ContextWhy GMPs Matters for NHPs?GMP Requirements for Natural Health Products in CanadaCompliance with the Canadian NHP RegulationsEstablishing a Quality SystemRaw Material and Supplier ControlsManufacturing Process ControlsRecord-Keeping RequirementsInternal Audits and Ongoing ComplianceProduct Testing and StabilityComplaint Handling and Recall ManagementKey Principles…
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