Health Canada Ends the NHP FSRN Process in Canada 
26
Feb
Site Licensing, , , ,

Health Canada Ends the NHP FSRN Process in Canada 

On February 16, 2026, the Health Product Compliance Directorate released Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin No. 10, confirming the end of the Foreign Site Reference Number (FSRN) process and clarifying the regulatory treatment of foreign warehouses. This update marks a significant shift in how Good…
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Health Canada Publishes 19 Updated NHP Monographs
05
Feb
NHPs, , , , , , , ,

Health Canada Publishes 19 Updated NHP Monographs

Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) has officially published 19 updated Natural Health Product (NHP) monographs as part of the January 30, 2026 load. These updates affect a wide range of botanical ingredients, amino acids, and commonly used actives across the Canadian NHP market. For regulatory teams,…
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Foundations of OOS Investigations for Natural Health Products (NHPs) in Canada 
29
Jan
NHPs, , , ,

Foundations of OOS Investigations for Natural Health Products (NHPs) in Canada 

Unexpected laboratory results are an unavoidable reality in natural health products (NHPs) manufacturing. A potency value that does not match historical performance, a microbial result that sits uncomfortably close to its limit, or a chromatographic profile that looks unfamiliar can all signal that something requires closer attention. These results do not automatically…
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Nicotine Buccal Pouches in Canada: Health Canada’s Amendment Clarifies Prescription vs. Non Prescription Status
27
Jan
NHPs, , , , , ,

Nicotine Buccal Pouches in Canada: Health Canada’s Amendment Clarifies Prescription vs. Non Prescription Status

Health Canada has officially updated the Prescription Drug List to clarify the non prescription status of nicotine buccal pouches containing 4 milligrams of nicotine or less per dosage unit. This change provides long awaited clarity for manufacturers, importers, and retailers entering the rapidly growing nicotine pouch category. The amendment, effective…
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Health Canada vs. FDA: Regulatory Frameworks and Compliance 
22
Jan
General Regulations, , ,

Health Canada vs. FDA: Regulatory Frameworks and Compliance 

Regulatory compliance in Canada requires adherence to federal, provincial, and, in some cases, municipal legislation governing the safety, quality, and labelling of products placed on the Canadian market. Health Canada administers the regulation of a broad range of products primarily under the Food and Drugs Act and its associated Food and Drug Regulations.…
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Health Canada Issues SOR/2025-248: A New Shortage Framework for Foods for a Special Dietary Purpose 
13
Jan
Food, , , , , , , , ,

Health Canada Issues SOR/2025-248: A New Shortage Framework for Foods for a Special Dietary Purpose 

On December 17, 2025, Health Canada published SOR/2025-248, Exemption Order in Respect of Foods for a Special Dietary Purpose in the Canada Gazette, Part II. This Order creates a formal mechanism to help maintain access to medically important nutrition products when Canada faces a shortage or risk of shortage. It also supports continued market access for…
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Health Canada Permits Caffeine in Supplemented Candies and Updates Labelling Requirements 
08
Jan
Supplemeneted Foods, , , , , , ,

Health Canada Permits Caffeine in Supplemented Candies and Updates Labelling Requirements 

On November 25, 2025, Health Canada published a Notice of Modification updating the List of Permitted Supplemental Ingredients to expand the permitted use of caffeine and introduce a new mandatory cautionary statement for certain high-caffeine solid supplemented foods.  If you manufacture, import, or private label functional gummies, caffeinated candies, or other solid…
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Health Canada Proposes Changes to Medical Device Establishment Licensing (MDEL): What Importers, Distributors, and Manufacturers Need to Know 
18
Dec
Medical Devices, , , , , , ,

Health Canada Proposes Changes to Medical Device Establishment Licensing (MDEL): What Importers, Distributors, and Manufacturers Need to Know 

On November 8, 2025, Health Canada published proposed amendments to the medical device establishment licensing framework in the Canada Gazette, Part I. The consultation is open for stakeholder feedback until January 17, 2026. If you hold, or are planning to apply for, a Medical Device Establishment Licence (MDEL), these proposed changes…
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Health Canada’s 2026 Proposed Updates to the Cosmetic Ingredient Hotlist: What Cosmetic Brands Need to Know 
04
Dec
Cosmetics, , , , , , , ,

Health Canada’s 2026 Proposed Updates to the Cosmetic Ingredient Hotlist: What Cosmetic Brands Need to Know 

Health Canada has begun a new consultation on proposed revisions to the Cosmetic Ingredient Hotlist, opening the door to significant changes in how cosmetic ingredients are reviewed, classified, and permitted for use in Canada. The consultation period runs from November 19th, 2025, to February 17th, 2026, marking a critical window for industry to…
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Health Canada Proposes New Food Enzyme Authorization: Exo-inulinase 
02
Dec
Food, , , , , , , , ,

Health Canada Proposes New Food Enzyme Authorization: Exo-inulinase 

On November 20th, 2025, Health Canada released a new proposal signalling its intention to authorize exo-inulinase from Trichoderma reesei strain AR 577 as a permitted food enzyme in Canada. If the proposal moves forward, the change would be implemented through an update to the List of Permitted Food Enzymes following a public consultation period that closes on February 3rd, 2026.  The List of…
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