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Regulatory Compliance for Cosmetics Sold in Canada

Regulatory Compliance for Cosmetics Sold in Canada

Executive Summary: Cosmetics sold in Canada need no pre-market approval from Health Canada, but sellers must follow the Food and Drugs Act and the Cosmetic Regulations. Key duties include using safe ingredients, providing clear labelling, and filing a Cosmetic Notification Form within 10 days of the first sale. Foreign brands must meet Canadian requirements. Every […]

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Building a Quality Management System for a Regulated Product Company

Building a Quality Management System for a Regulated Product Company

Executive Summary: A quality management system gives a regulated product company a clear framework for controlling processes, documents, people, and records. Built well, it supports consistent product quality, meets Health Canada expectations for natural health products, and keeps a business ready for inspections. Small teams can start with core procedures and grow the system as

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What Is a Site Licence in Canada and Who Needs One?

What Is a Site Licence in Canada and Who Needs One?

Executive Summary:A site licence in Canada is a federal authorization for companies that manufacture, package, label, or import regulated natural health products (NHPs) for sale. It authorizes specified activities at sites identified on the licence and requires licensees to comply with Good Manufacturing Practice standards in the Natural Health Products Regulations. Manufacturers, importers, and foreign

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Health Canada Inspection: A Complete Preparation Guide

How to Prepare for a Health Canada Regulatory Inspection

Executive Summary: Health Canada regulatory inspections assess GMP compliance across facility conditions, equipment, personnel, documentation, testing, quality control, and corrective actions. Inspection readiness depends on maintaining accurate records, current procedures, trained staff, effective quality systems, and timely issue resolution. Understanding common deficiencies and conducting regular internal reviews helps natural health product facilities identify gaps and

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