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Health Canada has released a Notice to Stakeholders outlining proposed updates to the Cosmetic Ingredient Hotlist. This notice serves as a heads-up for cosmetics manufacturers, importers, and formulators to review upcoming regulatory considerations and begin preparing for potential product reformulations. Overview: What is the Cosmetic Ingredient Hotlist? The Cosmetic Ingredient...

Canada's front-of-package (FOP) labelling requirements are designed to help consumers make healthier food choices by requiring certain prepackaged foods high in saturated fat, sugars, or sodium to carry a nutrition symbol. However, not all products are treated the same under these regulations. Many foods are either fully exempt or conditionally...

When most people think about prescription drugs, they may not consider the regulatory framework that determines which medicines are available only by prescription. But in Canada, this distinction is critically important and tightly governed by Health Canada through its Prescription Drug List (PDL).  In a recent regulatory update published on...

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...

Entering the Canadian pharmaceutical market requires more than just a good product—it requires regulatory approval. If you’re planning to sell prescription drugs, over-the-counter medications, medicated shampoos, or sunscreens in Canada, you’ll need a Drug Identification Number (DIN) issued by Health Canada.  The DIN is not just a tracking number; it’s...

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...

As part of its continued digital modernization, Health Canada has reaffirmed the requirement that drug product submissions be filed electronically, using either the Electronic Common Technical Document (eCTD) format or the non-eCTD format. The appropriate format depends on the type of regulatory activity and the product category. Health Canada’s April...

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...

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...

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...

In Canada, Good Manufacturing Practices (GMP) for Natural Health Products (NHPs) are essential guidelines that ensure products are manufactured safely, consistently, and in line with high quality standards. These practices cover every step of the product lifecycle, from sourcing raw materials to the final packaged product.   This blog will...

In the ever-evolving landscape of food labelling, it’s essential for businesses to stay up to date with regulatory changes. Recently, Health Canada released interim policy statements that address Front-of-Package (FOP) nutrition labelling for two specific categories of food: prepackaged fresh coconut and ready-to-eat breakfast cereals. These changes aim to clarify...

In Canada, the maple leaf and the Canadian flag are more than just symbols—they're the essence of what it means to be Canadian. From evoking national pride to representing our values, these emblems carry immense weight. But, as with anything valuable, they come with a set of rules. If you're...

On March 7, 2025, Health Canada released the Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine: SOR/2025-93, which builds upon the Interim Order published on May 17, 2024. This new order introduces more stringent regulatory oversight for natural health products (NHPs) containing ephedrine...

"Product of Canada" vs. "Made in Canada" Differences and Conditions of Use  Product labelling in Canada requires a careful approach, as many claims that appear on products are subject to regulations and must meet specific requirements to ensure compliance. While some companies may see these requirements as additional hurdles, regulating...

Canada's 2023 ban on animal testing for cosmetics represents a pivotal moment in the global push for ethical practices within the beauty industry. This landmark regulation not only prohibits the testing of cosmetics and their ingredients on animals within the country but also aligns Canada with a growing number of...

The world of beauty knows no borders, but, unfortunately, regulations certainly do. If you’re looking to import cosmetics from Europe to Canada, you’ll need more than just a great product, you will need a base level understanding of the rules on both sides of the Atlantic. The European Union (EU)...

In March 2025, Health Canada released an updated version of its Guide for Cosmetic Notifications, outlining important revisions to the Cosmetic Notification Form (CNF). These changes are designed to enhance regulatory compliance, improve transparency, and boost consumer safety.   Here’s an overview of the key updates businesses need to know. ...

As part of its ongoing efforts to modernize and streamline the submission process, the FDA is transitioning from its legacy Electronic Submission Gateway (ESG) system to ESG NextGen. This new platform is designed to make regulatory submissions more efficient, secure, and user-friendly, all while enhancing the overall user experience. The...

Celebrate Your Health, Celebrate Your Strength On International Women’s Day, we celebrate the resilience, power, and well-being of women everywhere. From balancing careers and families to embracing the changes that come with each stage of life, women’s bodies endure a lot. With hormones constantly shifting and new challenges arising, it...