While most companies focus heavily on obtaining product licences, fewer fully understand what can trigger a suspension or cancellation and what follows. This is why attention to post-market Natural Health Product (NHP) compliance activities is just as critical as pre-market considerations. Product labelling and meeting labelling requirements—including clear, legible label text, safety information, and up-to-date contact details—are essential aspects of regulatory compliance that help prevent adverse events and ensure consumer safety. The information referred to in regulations includes risk information and other mandated details. Health claims must be supported by appropriate evidence and are a key part of product licensing and labelling.
For regulatory professionals and licence holders, understanding this process is critical to risk management and business continuity. Without proper oversight or procedures, the opportunity for errors and subsequently the risk of product licence suspensions and cancellations increases.
A reminder of the Legal Framework
Product licence suspensions and cancellations are governed under the Natural Health Products Regulations, made under the Food and Drugs Act.
To legally manufacture, package, label, or import NHPs for sale in Canada, businesses must obtain both a site licence and a product licence. Each individual NHP must have its own product licence, identified by a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM). The application for a product licence must provide robust evidence to demonstrate the safety, efficacy, and quality of the NHP and Health Canada evaluates this evidence to make a determination on licensing. In light of an approval, manufacturers must follow Good Manufacturing Practices (GMP) to ensure product consistency and prevent contamination. NHPs must meet stringent quality standards to prevent contamination and minimize the risk of adverse effects. Health Canada requires that products meet defined safety and evidence requirements while maintaining a regulatory pathway proportionate to their intended use and lower risk profile.
Ultimately, Health Canada has the authority to suspend or cancel a product licence if there are reasonable grounds to believe that:
- The licensee has contravened the Regulations or the Act
- The product is no longer safe, effective, or of suitable quality
- False or misleading information was provided in the product licence application
- Required post-licensing obligations (e.g., reporting, GMP compliance) are not being met
- There is a change affecting the safety, efficacy, or quality of the product that has not been reported or approved
Common Suspension Triggers
- Good Manufacturing Practices (GMP) Non-Compliance
If a manufacturer, packager, labeller, or importer fails to meet GMP requirements (e.g., inadequate sanitation, stability data gaps, missing SOPs, insufficient quality control), Health Canada may determine that product quality cannot be assured.
- Safety Concerns
New evidence of serious adverse reactions, known adverse reactions, contamination (e.g., heavy metals), or formulation inconsistencies can prompt regulatory action. Reporting adverse reaction and known adverse reaction information is a critical part of risk information and post-market surveillance.
- Misrepresentation
If Health Canada determines that false or misleading information was submitted, whether about ingredients, potency, specifications, claims, safety information, or contra indication, this can result in suspension. Accurate communication of safety information and contra indications is essential to prevent health risks.
- Failure to Meet Post-Licensing Obligations
This may include failure to report serious adverse reactions, failure to notify of changes, or failure to maintain supporting evidence. Note, you must notify NNHPD of any change affecting product safety, efficacy, or quality using the Amendment/Notification Form (ANF).
Suspension vs. Cancellation: What’s the Difference?
Product Licence Suspension
- The NPN is placed “on hold”.
- The product cannot be legally sold in Canada during suspension.
- Health Canada typically provides a Notice of Intention to Suspend.
- The licensee usually has 90 days to respond and demonstrate corrective action.
- Suspension is meant to allow correction.
Product Licence Cancellation
- Occurs if deficiencies are not adequately addressed within the prescribed timeframe of a suspension notice.
- The NPN is revoked/cancelled.
- Reinstation not possible – To resume sale, a new product licence application must be submitted and approved.
- Cancellation is significantly more disruptive from both regulatory and commercial standpoints.
Non-compliance with Natural Health Products Regulations can lead to significant penalties for companies, including product seizures, financial penalties, and reputational damage or loss of retailer confidence, which may result in further financial losses. Health Canada actively monitors the NHP market and may take corrective actions against non-compliant products, impacting market access.
Overview: The Suspension Process
Step 1: Notice of intent
- Health Canada will issue a notice to the product licence holder outlining the reasons for the intended suspension.
Step 2: Licensee response
- Product licence holders have 90 days from the date of the notice to provide information or documentation to show the situation has been corrected or did not exist.
Step 3: Conclusion/Consequences
- Reinstatement: If a licence holder can successfully demonstrate the issue is resolved within 90 days, the product licence is reinstated.
- Cancellation: If information or documentation is not received within 90 days after the notice is issued, the licence will be cancelled and Health Canada will send licence holders a notice which clearly outlines the reason(s) for the cancellation and the day on which the cancellation is effective.
How to Prevent Suspension
Proactive regulatory governance is the strongest safeguard. Best practices include, but are not limited to:
- Conducting regular internal GMP audits
- Maintaining current, defensible evidence for safety and efficacy
- Ensuring change control procedures are robust
- Monitoring adverse event reporting systems
- Verifying all labels meet current and proposed labelling requirements
- Preparing for Health Canada inspections
- Monitoring Health Canada’s proposed changes to labelling requirements
- Reporting and obtaining approval for any post-licence changes
Preventative compliance is significantly less costly than remediation!
How can Dell Tech help?
In recent years, Health Canada has signaled increased oversight of NHP manufacturing and post-market compliance. For NHP companies, compliance should not be treated as a one-time licensing exercise. It is an ongoing obligation that requires structured systems, documentation discipline, and regulatory foresight.
At Dell Tech we have the expertise to help companies navigate both pre- and post-market regulatory obligations, including:
- Liaise with Health Canada to manage suspension notices or other post-licence requests.
- Assist with post-licence changes.
- Assist with new product licence registration.
We also support clients in adapting to proposed changes in labelling requirements and ensuring compliance with new standards as they come into force, including transition periods for existing products.
Dell Tech is here to support you through these high-impact regulatory actions that can significantly affect business operations.
Blog Author
Madelyn Martinez, H.BSc.
Madelyn Martinez is a Regulatory Affairs Specialist with nearly 7 years of experience in regulatory consulting. She specializes in natural health products, cosmetics, and food regulations, with a strong background in public health and policy.
