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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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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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
What Is a Site Licence in Canada and Who Needs One? Read More »
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
How to Prepare for a Health Canada Regulatory Inspection Read More »
Summary: This guide explains what Canadian product requirements involve for new businesses. It covers approval categories, documentation, and everyday compliance habits. Readers will also find a quick reference table and answers to common questions. A product sold in Canada looks simple on the shelf, but it rarely gets there without effort. Behind every bottle, box,
A Beginner’s Guide to Understanding Canadian Product Requirements Read More »
Summary: Selling a regulated product in Canada means working through classification, licensing, and ongoing reporting duties before a single unit reaches a shelf. This guide covers what international companies need to plan for: classification, site licensing, and import responsibilities. Canada offers real opportunity for companies selling regulated products, but the path in is lined with
What Every Business Should Know Before Entering Canada’s Regulated Market Read More »
If you plan to sell a natural health product in Canada, obtaining a Natural Product Number (NPN) is one of the most important regulatory requirements. Whether you are launching a dietary supplement, herbal product, vitamin, mineral, probiotic, or traditional medicine, Health Canada generally requires product licensing before the product can be legally marketed. Many companies
How to Obtain an NPN in Canada: A Step-by-Step Guide for Natural Health Products Read More »
Obtaining a Natural Product Number (NPN) is a critical step for bringing a Natural Health Product (NHP) to the Canadian market. While Health Canada provides multiple licensing pathways, many companies experience significant delays, requests for additional information, or outright refusals due to avoidable application deficiencies. Whether you are launching a dietary supplement, vitamin, mineral, herbal
One of the most common and costly mistakes health product companies make is assuming they know how their product will be regulated in Canada. A product that appears to be a cosmetic may actually be classified as a Natural Health Product (NHP). A wellness supplement may be considered a drug based on its claims. A
NHP, Cosmetic, Medical Device or Drug? Understanding Product Classification in Canada Read More »
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