Our streamlined process ensures efficient and effective management of your GMP site licence application:

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Step 1: Initial Consultation
We assess your business needs and determine the activities to include in your application.

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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.

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Step 3: Facility Compliance Review
Our team evaluates your facility to identify and recommend updates needed for full compliance.

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Step 4: Application Submission
We compile and submit the complete site licence application to Health Canada on your behalf.

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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.

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Step 6: Approval and Ongoing Support
Once approved, we provide service for licence renewals, amendments, and maintaining compliance through regular audits or process updates.

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This clear and efficient process ensures your GMP site licence is secured without unnecessary delays, allowing you to focus on growing your business.
 

The required documents depend on the activities included in the application (e.g., manufacturing, packaging, labelling, importing). Typically, you will need:

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• 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.

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.

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We help identify pre-cleared GMP evidence and streamline the process to minimize delays and expedite approval.

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.