Health Canada has introduced important updates to the management of Natural Health Products (NHPs) to enhance efficiency in the approval process. These changes specifically affect Class III NHP submissions, which will now be prioritized based on whether the products are being sold or manufactured in Canada. By focusing on these key products, Health Canada aims to streamline the regulatory process, ensuring that NHPs available to Canadians meet safety and quality standards. These updates are designed to improve overall efficiency in the approval and monitoring of NHPs.
Prioritization of Class III NHP Submissions
Starting on March 5, 2025, Health Canada’s Natural and Non-Prescription Health Products Directorate (NNHPD) will implement a significant change in how it handles Class III NHP submissions. Instead of processing applications on a first-come, first-served basis, the NNHPD will adopt a prioritization system. This system will ensure that applications and amendments are evaluated according to specific criteria, with a focus on products most relevant to the Canadian market. This shift aims to allocate resources more effectively, speeding up the review of products that have the greatest impact on consumers.
Criteria for Prioritization
NNHPD will prioritize Class III NHP applications and amendments that meet at least one of the following criteria:
- New applications: Products intended for sale in Canada within six months of receiving authorization.
- Amendments: Changes to existing NHPs that are currently sold or will be sold in Canada within six months.
- Health & safety considerations: Amendments required due to identified risks to consumer safety.
- Manufacturing in Canada: Products that will be manufactured in Canada within six months of licensing.
Submission Requirements
To facilitate prioritization, applicants must submit a Workload Management Form with their application or amendment. This form confirms that the product meets one or more of the prioritization criteria. Manufacturers must choose between two forms:
- Workload Management Form – Products Sold in Canada: For products to be sold (and, if applicable, manufactured) in Canada.
- Workload Management Form – Manufactured in Canada: For products to be manufactured but not sold in Canada.
The completed form must be submitted within 15 calendar days of receiving an acknowledgment letter from Health Canada for applications submitted after March 5, 2025. For applications submitted before this date, the form is due by May 1, 2025. Failure to submit the form may result in deprioritization.
For more information on this change, please visit Health Canada’s publication.
Upcoming Changes to NHP Labelling Requirements
In addition to recent prioritization changes, Health Canada has updated the NHP labelling regulations with a focus on improving the consistency, clarity, and accuracy of information provided to consumers. These changes will require manufacturers to update labels to ensure that critical information, such as health claims, ingredients, and dosage, is presented in a clear, standardized format. This update will also involve stricter rules for product claims and ingredient lists. Manufacturers must ensure their labels comply with the new Plain Language Labelling requirements by June 21, 2028.
For further details, read our blog post: Overview of New Plain Language Labelling Regulations for Natural Health Products in Canada
Frequently Asked Questions (FAQ)
- What is a Natural Health Product (NHP)? In Canada, NHPs include substances like vitamins, minerals, herbal remedies, homeopathic medicines, traditional medicines, probiotics, and other products such as amino acids and essential fatty acids.
- Why are NHPs regulated under the Food and Drugs Act? Regulating NHPs under the Food and Drugs Act ensures they meet safety, efficacy, and quality standards, providing Canadians with safe and effective products.
- How does Health Canada ensure the safety and quality of NHPs? Health Canada assesses NHPs for safety, efficacy, and quality before they can be sold in Canada. Manufacturers must comply with Good Manufacturing Practices (GMP) to ensure product quality.
- What is a Natural Product Number (NPN)? An NPN is an eight-digit number that appears on NHP labels, indicating that the product has been reviewed and approved by Health Canada for safety, efficacy, and quality.
- How can I import NHPs into Canada? Importers must hold a valid site license and ensure that imported products come from facilities meeting Canadian GMP standards. A Quality Assurance Report for each site must be submitted with the site license application.
Regulatory Support
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