NHP Site Licensing & Audits in Canada

Stay compliant and audit-ready with our NHP Site Licensing and Audit services. We help you navigate Health Canada’s requirements so you can apply, maintain, and renew your site licence with confidence. 

Your Guide to the NHP Site Licence in Canada

Health Canada requires all companies that manufacture, package, label, or import Natural Health Products (NHPs) to hold a valid NHP site licence. Inspections and audits are part of keeping that licence in good standing. 

Our specialists guide you through the full process, from preparing your initial application to supporting you during an audit. That way, you can avoid delays, rejections, or costly compliance findings. 

Our NHP Site Licensing & Audit services

We prepare and submit your application package to Health Canada, ensuring all requirements are met, including evidence of GMP compliance.

We manage renewals to keep your licence active, preventing interruptions to your operations.

We conduct internal reviews and mock audits so you’re ready for Health Canada inspections.

If there are any deficiencies, we help you create and implement corrective action plans.

Our experts provide ongoing support to ensure your facility stays aligned with Health Canada’s expectations.

Why Site Licensing And Audits Matter

Without a valid site licence, you cannot legally manufacture, package, label, or import NHPs in Canada. A failed audit or missing renewal can lead to suspension, loss of market access, or reputational damage. With our guidance, you’ll: 

Maintain compliance with Health Canada requirements

Prevent interruptions in business operations

cosmetic form

Be fully prepared for inspections

Protect your reputation with clients and regulators

Customized To Your Operations

Every NHP facility is different. We tailor our licensing/audit support based on: 

Who This Service Is For

Our licensing and audit services support all NHP-related operations: 

Manufacturers

Packagers

Labelers

Importers

Why work with us?

18+ years navigating Health Canada NHP compliance
Deep experience in site licence applications, renewals, and audits
Guidance from experts who understand Health Canada’s inspection process
Actionable recommendations tailored to your facility
Support for both new applicants and established licence holders

FAQs On NHP Site Licensing

Any company that manufactures, packages, labels, or imports Natural Health Products (NHPs) for sale in Canada must hold a site licence. This applies whether you are a Canadian-based company or an international business planning to bring products into the Canadian market.

An NHP (Natural Health Product) site licence needs to be renewed annually for the first three years, then every two years for the following three renewals, and finally every three years thereafter. The licence is typically issued for a one-year term, with renewals occurring at progressively longer intervals as the site gains experience and compliance history. All renewals must be submitted to Health Canada at least 30 days before the current licence expires to avoid having to submit a new application. The renewal frequency depends on how long the site has held its licence: 

  • Years 1-3 (or the first three renewals): Annual renewal
  • Years 4-6 (or the next three renewals): Renewal every two years
  • Year 7 and beyond (or after nine years of holding the license): Renewal every three years

If deficiencies are identified, Health Canada will require you to submit corrective action plans with clear timelines. We support you by analyzing the findings, preparing the necessary documentation, and helping you implement changes so you can maintain your licence in good standing.

Yes. International companies that import NHPs into Canada must also hold a site licence. We guide overseas organizations through the licensing and audit process, ensuring their documentation and facilities meet Health Canada’s expectations.

Yes. We deliver GMP training and site audit preparation programs designed specifically for NHP facilities. Training can be tailored to your team’s roles and experience levels, ensuring everyone understands their responsibilities and is ready for inspections. 

Get In Touch

Let’s make your FDA compliance journey clear and achievable. Our team is ready to support your next steps. 

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