Over the past few weeks, many natural health product (NHP) companies have been caught off guard by an increase in site license suspensions or renewal refusals. Health Canada is reinforcing its compliance expectations and taking action where gaps are found. If your site license renewal is coming up, this is the time to double-check your processes.
A single oversight, such as missing documentation or insufficient GMP evidence, can trigger delays or a full suspension. To avoid costly disruptions, it is imperative that you take a proactive approach to meeting Health Canada’s expectations. Keep reading to learn what you need to know, and how to stay ahead.
What is Health Canada expecting during your NHP site license renewal
Health Canada is paying closer attention to how you handle compliance. This includes how thoroughly you investigate non-conformances, whether your QAP has documented GMP experience, how you manage deviations before releasing products, and how effective your CAPA (Corrective and Preventive Action) process is, and whether you have a functioning recall program in place.
A weak or incomplete CAPA, such as one missing a retrospective review of affected batches, can lead to refusal or suspension. Health Canada now expects companies to proactively identify root causes, implement targeted solutions, and document each step taken to prevent future recurrence. They’ve outlined these expectations in a bulletin on how to develop a CAPA, which every company should review.
Common reasons for license refusal or suspension
If your site license was refused or suspended, here are some likely reasons:
- CAPAs submitted were incomplete or didn’t include adequate root cause analysis
- No documented GMP training or experience for your QAP
- Inadequate investigation into deviations or product release failures
- Failure to update procedures in line with the most recent Health Canada guidance
These are some common red flags that your site may not meet GMP standards.
How to prepare for your next renewal
Start by reviewing the latest Health Canada bulletins. Next, make sure your QAP’s GMP experience is clearly documented. Finally, conduct a thorough internal audit and revise your SOPs accordingly so they align with the most recent guidance and expectations.
If you’re unsure about your readiness or need help interpreting regulatory requirements, it’s time to seek professional support.
Frequently asked questions
Can my license be suspended even if I’ve submitted a renewal?
Yes. A submitted renewal doesn’t mean your license is safe. If Health Canada finds gaps in documentation, GMP practices, or unresolved inspection issues, they can suspend or refuse your license.
What if I made a mistake?
Mistakes happen, but Health Canada expects you to act fast and responsibly. If a product was released out of specification, you are expected to conduct a full retrospective analysis and implement appropriate CAPAs. Ignoring the issue or submitting incomplete documentation increases your risk of non-renewal.
The good news is that transparent, proactive responses with expert guidance can improve your chances of a successful renewal.
Do I need a QAP with GMP experience?
Absolutely. One of the most common reasons for license refusal is appointing a QAP without documented GMP experience. Your QAP must be able to demonstrate relevant knowledge and training that align with Health Canada’s expectations.
What happens if my CAPA is incomplete?
If your Corrective and Preventive Action plan doesn’t fully address the issue. For example, if you miss a retrospective review, Health Canada may consider your response inadequate. Depending on the severity of the issue, your renewal will experience either delays, or even a complete rejection and suspension, leading to a loss of market access and sales.
How often should I review my procedures?
SOPs should be reviewed and updated regularly to reflect the latest regulatory requirements. A best practice is to review them annually or immediately following any major inspection findings, regulatory updates, or operational changes.
Can I still recover from a suspension?
Yes, but it takes time and effort. You’ll need to submit a strong remediation plan, demonstrate corrective actions, and possibly undergo re-inspection. Working with an expert can significantly improve your chances of regaining your license.
Why work with a compliance expert
A regulatory consultant can guide you through every stage of the renewal process. From reviewing documentation and identifying compliance gaps to training your QAP on GMP expectations, the right support makes all the difference.
At Quality Smart Solutions, we’ve supported hundreds of successful NHP site license renewals. Our team can help you navigate the process and avoid costly mistakes.
Don’t wait until it’s too late
The increase in Health Canada enforcement actions shows how critical proper site license renewal preparation is. Whether your renewal is due soon or you’ve recently faced challenges, it’s time to act.
Contact us today to speak with our regulatory experts. We’ll help you stay compliant, protect your business, and ensure your NHP operations run smoothly.
Looking for more guidance? Visit our NHP site license page to learn how we can help.
