Nicotine Tablets Now Non-Prescription in Canada: Health Canada Updates the Prescription Drug List 

Nicotine Tablets Now Non-Prescription in Canada: Health Canada Updates the Prescription Drug List 

Overview of the Prescription Drug List Change  On July 21, 2025, Health Canada implemented a regulatory amendment that exempts certain nicotine tablets from the human-use section of the Prescription Drug List (PDL). This change applies specifically to orally disintegrating and sublingual nicotine tablets that contain no more than 4 milligrams…
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Natural Health Product (NHP) Regulations in Canada: A High-Level Overview for Businesses

Natural Health Product (NHP) Regulations in Canada: A High-Level Overview for Businesses

Canada’s growing wellness market presents a strong opportunity for companies looking to expand their product offerings, especially in the natural health space. But before launching any Natural Health Product (NHP), businesses must navigate Canada’s robust regulatory framework. Understanding the basics of NHP compliance is key to accessing the Canadian market,…
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Health Canada Publishes Updated Natural Health Products Monographs – June 27, 2025 Update 

Health Canada Publishes Updated Natural Health Products Monographs – June 27, 2025 Update 

On June 27, 2025, Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) will release eight new monographs and revise three existing ones. These updates are part of Health Canada’s continued efforts to maintain regulatory guidance that is accurate, up to date, and reflective of current evidence and product trends. …
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Quality Assurance Processes for Natural Health Products in Canada 

Quality Assurance Processes for Natural Health Products in Canada 

Quality assurance (QA) plays a central role in the safety and credibility of natural health products (NHPs) in Canada. Manufacturers are required to meet high standards set by Health Canada to ensure their products are safe, effective, and made with consistent quality before they reach the consumer.  Canada’s regulatory framework…
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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 License a Sunscreen Product in Canada — Step-by-Step for NHPs and NPDs 

How to License a Sunscreen Product in Canada — Step-by-Step for NHPs and NPDs 

Sunscreen is more than a summertime staple; it's a frontline defence against premature aging, sunburn, and skin cancer. As consumer awareness around sun protection continues to grow, so does the demand for innovative, high-quality sunscreen products. But behind every tube on a drugstore shelf lies a rigorous regulatory journey. In…
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Understanding Sunscreen Licensing in Canada — Regulatory Pathways and Health Canada’s Role

Understanding Sunscreen Licensing in Canada — Regulatory Pathways and Health Canada’s Role

Over the years, research has consistently highlighted just how important sunscreen is in a daily skincare routine. Some people were ahead of the curve, protecting their skin from harmful UV rays long before sunscreen became a non-negotiable part of everyone’s morning regimen. But what many don’t realize is that bringing…
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Health Canada NHP Monograph Updates Coming April 25, 2025: What You Need to Know 

Health Canada NHP Monograph Updates Coming April 25, 2025: What You Need to Know 

If you're working with Natural Health Products (NHPs) in Canada, it's essential to stay ahead of Health Canada’s regulatory updates. As of April 25, 2025, five updated NHP monographs will be published, and they may impact product licences, labelling, and formulation strategies.  Whether you're submitting a new Product Licence Application…
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How to Prepare Finished Product Specifications (FPS) for NHPs 

How to Prepare Finished Product Specifications (FPS) for NHPs 

Finished Product Specifications (FPS) are crucial documents that outline the minimum quality standards an Natural Health Product (NHP) must meet before it can be imported, sold, or distributed in Canada. These specifications are mandated under Health Canada's Natural Health Products Regulations (NHPR), and every NHP must strictly comply with the…
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NHP Sampling Regulations for Tradeshows in Canada 

NHP Sampling Regulations for Tradeshows in Canada 

Distributing Natural Health Product (NHP) samples at tradeshows in Canada is subject to clear regulatory requirements designed to protect consumer safety, ensure accurate labelling, and uphold Health Canada’s standards.  From proper packaging and compliant promotional claims to valid licensing and record-keeping obligations, all participants are responsible for operating in accordance…
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