WHAT IS A HEALTH CANADA LICENCE AND WHY IT MATTERS

What Is a Health Canada Licence and Why It Matters

What Is a Health Canada Licence and Why It Matters

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If you're looking to manufacture, sell, or distribute health-related products in Canada—such as pharmaceuticals, medical devices, or natural health products—you’ll likely need a Health Canada licence. This official authorization ensures that products meet strict safety, quality, and efficacy standards before reaching the public.


There are several types of Health Canada licences, depending on the product or service:





  • Drug Establishment Licence (DEL) – For companies involved in the manufacturing or importing of pharmaceutical drugs.




  • Medical Device Licence (MDL) – Required for manufacturers of Class II, III, and IV medical devices.




  • Site Licence – For companies making or packaging natural health products.




  • Cannabis Licence – For businesses involved in growing, processing, or selling cannabis products.




The licensing process involves detailed applications, compliance with Good Manufacturing Practices (GMP), and ongoing inspections. Though rigorous, it plays a critical role in protecting public health and maintaining trust in the Canadian healthcare system.


If you're planning to enter this highly regulated market, securing the right Health Canada licence is your first step toward legal and ethical operations.

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