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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,...

The U.S. Food and Drug Administration (FDA) has announced a major regulatory update, revoking or proposing to revoke 52 existing food Standards of Identity (SOIs) following a comprehensive internal review. This decision represents a significant shift toward modernizing food regulation in the U.S. and is expected to impact both U.S....

Health Canada’s Food and Nutrition Directorate has recently published an interim report on sodium reduction efforts in processed foods. While certain product categories have demonstrated progress, others have experienced an increase in sodium content. Excessive sodium intake remains a leading dietary risk factor in Canada, contributing to elevated blood pressure,...

The licensing pathway for contraceptive products in Canada can be complex, particularly for manufacturers and importers aiming to introduce new products or expand existing lines. One of the main challenges is the lack of clear, consolidated guidance that explains how different types of contraceptives are regulated under Canadian law. Hormonal...

Canada is taking proactive steps to prevent disruptions in access to foods for special dietary purposes (FSDP) with a new proposal from Health Canada. On June 30, 2025, the department published an updated Notice of Intent outlining a proposed Ministerial class exemption order aimed at mitigating shortages and maintaining access...

The process of bringing contraceptive medical devices to the Canadian market involves navigating a clearly defined but often complex regulatory framework. Products such as intrauterine devices (IUDs), diaphragms, condoms, and contraceptive sponges are considered medical devices and are regulated by Health Canada under the Medical Devices Regulations. This overview outlines...

When your Canadian importer changes, it’s not just a back-end operational update, it also triggers a regulatory obligation to update your product labels. Canadian food labelling regulations are designed to maintain transparency, traceability, and accountability across the supply chain. While the Canadian Food Inspection Agency (CFIA) offers flexibility during transitional...

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. ...