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When foreign facilities manufacture, package, or label Natural Health Products (NHPs) for the Canadian market, Health Canada requires proof that these sites meet Good Manufacturing Practices (GMPs). To simplify this process, the Natural and Non-prescription Health Products Directorate (NNHPD) issues a Foreign Site Reference Number (FSRN).   An FSRN acts as...

An essential element of regulatory compliance in any product sector is ensuring that product labels meet the specific requirements of the country where the products are sold and that they clearly communicate the product’s intended use. This requirement is no different for pet food products, which are also subject to...

Clinical trials for natural health products (NHPs) such as vitamins, herbal remedies, and probiotics bring scientific rigour to traditional health claims. In Canada, where consumer protection and evidence-based regulation are priorities, sponsors are beginning to shift away from running isolated trials toward building comprehensive clinical research strategies. This shift reflects...

Adhering to good manufacturing practices (GMP) is a cornerstone of regulatory compliance for companies in the natural health product (NHP) industry. In Canada, GMP requirements are outlined in Health Canada’s Good manufacturing practices guide for natural health products (GUI-0158), which supports Part 3 of the Natural Health Products Regulations. The...

Cutting red tape is at the heart of Health Canada and the Public Health Agency of Canada’s new regulatory modernization plan. In July 2025, the Government of Canada launched a federal Red Tape Review to address growing concerns that outdated, duplicative, and overly complex rules are slowing market access, discouraging...

On September 4, 2025, the U.S. Food and Drug Administration (FDA) published its Unified Regulatory Agenda, a key planning document that outlines the Agency’s top priorities over the coming year. Among the many proposed and final rules, three initiatives stand out for their potential to significantly impact food and dietary...

On September 2, 2025, Health Canada updated the Table of Permitted Nutrient Content Statements and Claims, modifying the table to once again exempt chewing gum from the energy conditions set out under the “free of sugars” claim.  Learn more about this regulatory change and what it means for manufacturers and...

Health Canada has announced updates to the Prescription Drug List (PDL) that affect both human and veterinary drugs. This amendment introduces four new medicinal ingredients that now require a prescription and revises the conditions under which benzoyl peroxide is considered prescription-only for human use. These changes are effective immediately as...

Whether you are an established medical device manufacturer or entering the Canadian market for the first time, determining the correct classification is the essential first step in licensing your product. An incorrect classification can lead to costly errors, regulatory delays, and extended time to market, ultimately resulting in lost revenue....

Red light therapy devices have become increasingly popular for skin health, from cosmetic uses to therapeutic applications. As demand for non-invasive skin treatments grows, so does the need for regulatory clarity. While these products are often marketed as cosmetic or wellness tools, many fall under Health Canada's definition of a...

Good Manufacturing Practices (GMP) for cosmetics in Canada are regulatory guidelines ensuring the safety, quality, and consistency of cosmetic products. To this end, they are specifically detailed by Health Canada under the Cosmetic Regulations, who mandate that manufacturers adhere to rigorous standards for production, record keeping, and quality control.   GMP...

On July 25, 2025, Health Canada published six new Natural Health Product (NHP) monographs, along with minor revisions to five existing monographs. These updates form part of Health Canada’s ongoing effort to align the Natural Health Products Ingredients Database (NHPID) and related monographs with the latest scientific evidence, safety considerations,...

If you’re looking to sell pet supplements in Canada, there are several critical factors to consider to ensure regulatory compliance. From notifying Health Canada about your product to ensuring accurate labelling and understanding importation regulations, entering the Canadian market requires careful planning and a comprehensive understanding of the local regulatory...

In Canada, any business that manufactures, packages, labels, or imports natural health products (NHPs) must hold a valid site licence obtained from Health Canada. This licence confirms that the company complies with the requirements set out in the Natural Health Products Regulations and Site Licensing Guidance Document, including adherence to...

On July 25, 2025, Health Canada published a Notice of Proposal (Reference No. P-SIS-25-02) outlining its intent to amend the List of Permitted Supplemental Ingredients to allow up to 30 percent juice content in certain caffeinated beverages. This proposal, which applies to both carbonated and non-carbonated water-based beverages, would adjust...

As the demand for high-quality pet food continues to rise across Canada, so too does the need for a clear understanding of the regulations that govern its production, labelling, import, and sale. Whether you are a manufacturer, importer, brand owner, or retailer, ensuring that your pet food products comply with...

The Canadian Natural Health Product (NHP) industry is preparing for one of its most significant regulatory shifts in nearly two decades. With the introduction of Health Canada’s new Plain Language Labelling (PLL) Regulations (Labelling for Natural Health Products), businesses that manufacture, distribute, or sell NHPs must rethink how their product...

When entering the Canadian market, medical device manufacturers face a complex regulatory system designed to safeguard patient safety and public health. Central to this framework is the classification of devices into classes I to IV, based on risk. This walk-through explains how Health Canada’s regulatory environment works, outlines each device...

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...

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,...