Health Canada Natural and Non-prescription Health Products Directorate (NNHPD) has updated its guidance regarding how applications for natural health products (NHPs) (new, or amendments and notifications for existing products) are processed, assessed and issued a regulatory decision. These updates are intended to achieve better outcomes for the health and safety of Canadians by ensuring that authorized NHPs meet regulatory requirements and align with the policy of current practices, tools and systems.
One of the recently updated areas is Information Request Notices (IRNs) issued by Health Canada.
The Directorate aims to issue only one comprehensive IRN that includes all deficiencies identified with the application; the IRN will have a specified response time between 2 to 15 calendar days depending on the complexity of the information requested.
The response to NNHPD must address each of the items listed in the comprehensive IRN and the Directorate acknowledges that it is the responsibility of applicants to be available (or have a designated party available) to respond to IRNs in a timely manner. NNHPD will not send IRNs for issues identified in a previous IRN that are not adequately addressed nor will NNHPD request information a second time if the applicant has submitted an incomplete or deficient response. Instead the Product License Application (PLA) will be rejected.
Linda Beach is the founder, sole owner, and Director of Canadian Natural Health Product Registry (CNHPR), operating under Medical Botany Research. Based on Canada’s west coast, Linda has been providing regulatory consulting and compliance expertise to Canadian and international companies since 2004, when Canada’s Natural Health Products Regulations first came into effect.
A Certified Herbalist with a degree in Botany and Medical Research, Linda also holds certifications in several natural and complementary healing modalities. This combination of scientific training and hands-on herbal expertise gives her a unique perspective on the products she helps bring to market — from vitamins and herbal remedies to nutraceuticals, cosmeceuticals, and sports supplements.
Over her two decades working directly with Health Canada, Linda has built strong working relationships with regulators that have translated into consistent success in securing Natural Product Numbers (NPNs) for her clients. Her advocacy work has had industry-wide impact — including playing a key role in Health Canada’s decision to reinstate hempseed oil to its approved ingredient database after it had been removed, restoring a path to market for products containing the ingredient.
Through CNHPR, Linda guides clients through every stage of the licensing process: developing a tailored regulatory strategy, compiling required documentation, and managing submissions from signing through to Health Canada approval.