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Our expertise maximizes your probability of approval by integrating strategic product refinements with rigorous scientific validation.
New Site License Application
Explore the essentials of GMP site licensing and how it ensures seamless compliance with Canadian regulations.
For Post-Licensing Services
Already licensed? Explore how our post-licensing services ensure you remain compliant and operational.
For Foreign Site Reference Number
Selling to Canadian importers? Discover how an FSRN streamlines compliance for foreign manufacturing sites.
Why Do You Need a GMP Site Licence?
If your Canadian business manufactures, packages, labels, or imports natural health products (NHPs), a Site License is a mandatory regulatory requirement.
Health Canada requires all entities performing these activities to hold a valid license issued by the Natural Health Products Directorate (NHPD).
While licenses are exclusive to Canadian operations, foreign manufacturers and partners must be officially linked to a Canadian importer’s license to ensure full compliance.
Our Approach to Your Site Licence Application
Our team streamlines the GMP site licensing process through expert guidance and strategic support.
Activity Determination
Define the core activities—manufacturing, packaging, labeling, or importing—to be included in your application.
2. Documentation Support
Partner with you and your stakeholders to coordinate and prepare all necessary documentation and evidence for site license applications, amendments, or renewals.
3. Compliance Readiness
Deliver tailored regulatory guidance, including drafting and revising SOPs, advising on product testing, and recommending facility upgrades.
How Our Services Support Your Post-Licensing Needs
Our team simplifies the GMP site licensing process by providing expert guidance and support
For Renewals:
Health Canada requires renewal requests to be submitted no later than 30 days before the licence expires. In some cases, earlier submission may be necessary.
We help identify the appropriate submission timeline and ensure all required documentation is updated and submitted on time
2. For Amendments:
Certain changes require pre-approval from Health Canada. These include, but are not limited to:
Adding new activities (e.g., manufacturing or importing).
Adding new buildings for manufacturing, packaging, labelling, or storage.
Transitioning from non-sterile to sterile dosage forms.
Adding new foreign sites to your licence.
3. For Notification:
Some changes require a site licence notification rather than an amendment. As per Health Canada regulations, licensees must notify the NNHPD within 60 calendar days of changes, such as:
Updates to the name, mailing address, telephone number, fax, or email address.
Substantial changes to buildings, equipment, practices, or procedures.
Not sure if you need a renewal, amendment, or notification? Contact us today to determine the appropriate application type and estimated timelines.
What is FSRN and Why Do You Need One?
A Foreign Site Reference Number (FSRN) is issued by the NNHPD to international manufacturers, packagers, and labelers of NHPs.
An FSRN serves as official verification of GMP compliance for foreign facilities, aligning with Canadian regulatory standards.
Acquiring an FSRN provides significant strategic advantages for international manufacturers, packagers, and labelers:
Streamlined Approval
Streamlines compliance by eliminating redundant GMP submissions to multiple Canadian importers, optimizing both time and resources.
3. Credibility
Facilitates direct communication with Health Canada, safeguarding proprietary business data by submitting sensitive documentation independently of importers.
2. Credibility
Demonstrates full adherence to Canada’s NHP GMP standards, reinforcing credibility and trust with Canadian importers.
4. Efficiency
Serves as pre-verified evidence for importer site license applications, accelerating processing timelines and streamlining regulatory compliance.
Sample of Health Canada Site Licence
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Process Overview
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Our Process Overview
Our streamlined process ensures efficient and effective management of your GMP site licence application:
Step 1: Initial Consultation
We assess your business needs and determine the activities to include in your application.
Step 2: Documentation Preparation
We collaborate with you to gather required documents, including SOPs, product testing records, and facility information, ensuring they meet Health Canada’s GMP standards.
Step 3: Facility Compliance Review
Our team evaluates your facility to identify and recommend updates needed for full compliance.
Step 4: Application Submission
We compile and submit the complete site licence application to Health Canada on your behalf.
Step 5: Communication with Health Canada
We handle all interactions with Health Canada, including responding to IRNs, ensuring timely and accurate replies to any additional requests.
Step 6: Approval and Ongoing Support
Once approved, we provide service for licence renewals, amendments, and maintaining compliance through regular audits or process updates.
This clear and efficient process ensures your GMP site licence is secured without unnecessary delays, allowing you to focus on growing your business.
FAQ
What documents are required for a site licence application?
The required documents depend on the activities included in the application (e.g., manufacturing, packaging, labelling, importing). Typically, you will need:
A detailed description of the activities performed.
Standard Operating Procedures (SOPs) for each GMP requirement (e.g., sanitation, personnel, quality assurance, product release).
A site master file or facility documentation, including floor plans and equipment details.
Records demonstrating product testing, stability data, and specifications.
Evidence of compliance with personnel training requirements.
We assist in gathering and formatting all necessary documents to ensure compliance with Health Canada’s guidelines.
How long does it take to obtain a GMP Site Licence?
The GMP assessment timeline depends on the number of sites and activities included in the application. Applications that meet all requirements and require no additional information typically take up to 90 days for Canadian sites, based on Health Canada’s Service Standards. However, recent high application volumes may cause delays.
We help identify pre-cleared GMP evidence and streamline the process to minimize delays and expedite approval.
Do l need to hold a Site Licence if l am importing NHP only?
Yes, if you are importing Natural Health Products (NHPs) for the purpose of sale in Canada, you must hold a valid GMP Site Licence. The importer is responsible for ensuring that the foreign manufacturing, packaging, and labelling sites comply with Canadian GMP standards. Importers must maintain proper documentation and oversight of their foreign suppliers.
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