SITE LICENCING

To get a Site License for Natural Health Products (NHPs) in Canada, you need to:

1. Ensure your facility meets Good Manufacturing Practices (GMP) standards.
2. Set up strong quality assurance systems to ensure product safety and quality.
3. Provide detailed information about your products, including ingredients and intended use.
4. Submit thorough details about your manufacturing site, including equipment and sanitation practices.
5. Keep comprehensive records of production, ingredients, and quality control tests.
6. Make sure you comply with Health Canada’s regulations and guidelines, especially those in the Natural Health Products Regulations.

By meeting these requirements   you can get a Site License to make and sell NHPs in Canada.

Foreign NHP manufacturing sites must be annexed to an importer’s valid site license, and attest to following Good Manufacturing Practices (GMP).

Good Manufacturing Practices (GMP) are crucial for quality assurance. They ensure that natural health products are consistently made, controlled, and meet the necessary quality standards for their intended use.

Yes, having Standard Operating Procedures (SOPs) is typically essential for obtaining a Site License for Natural Health Products (NHPs) in Canada. SOPs outline the specific procedures and processes that must be followed to ensure compliance with regulatory requirements and maintain the quality, safety, and efficacy of the products being manufactured. These SOPs demonstrate to Health Canada that your facility operates in accordance with Good Manufacturing Practices (GMP) and other relevant regulations. They cover various aspects of operations, including facility management, quality control, documentation, personnel training, equipment maintenance, material handling, cleaning, and change control. Having well-defined SOPs helps ensure consistency, traceability, and accountability in the manufacturing process, which are crucial for obtaining and maintaining a Site License.

Here are the main SOPs you’ll likely need:

1. Facility Management: Covers how to run and maintain your manufacturing site, including cleaning, maintenance, security, and waste disposal.
2. Quality Control: Details how to test and ensure quality throughout production, including testing raw materials, during production, and of finished products.
3. Documentation and Record-Keeping: Explains how to keep accurate records of production, including batch records, logs, and reports of any issues.
4. Personnel Training: Describes how to train staff involved in manufacturing and quality control so they can do their jobs properly.
5. Equipment Calibration and Maintenance: Sets out how to keep manufacturing equipment accurate, reliable, and clean, meeting GMP standards.
6. Material Handling and Storage: Outlines how to safely handle, store, and label raw materials and finished products to avoid contamination and errors.
7. Cleaning and Sanitization: Gives guidelines for keeping the site, equipment, and utensils clean and hygienic to prevent contamination.
8. Change Control: Details how to assess and make changes to processes, equipment, or materials without affecting product quality or breaking regulations.

Following these SOPs shows your commitment to quality, safety, and meeting regulations, which helps you get and keep your Site License for NHPs in Canada.Top of Form

To import Natural Health Products (NHPs) into Canada, you typically need to fulfill several requirements:

1. Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM): Before importing NHPs for sale in Canada, you need to obtain either a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) from Health Canada. These numbers indicate that the product has been assessed for safety, efficacy, and quality.

2. Valid Site License: If you are importing NHPs for commercial purposes, the manufacturer must hold a valid Site License issued by Health Canada. This license demonstrates that the manufacturing facility meets Good Manufacturing Practices (GMP) standards.
3. Labeling Requirements: NHPs imported into Canada must meet specific labeling requirements set by Health Canada. Labels must include essential information such as product name, ingredients, dosage instructions, warnings, and NPN or DIN-HM numbers.
4. Documentation: You may need to provide various documents to Health Canada, including product information, labeling artwork, stability data, and evidence of compliance with regulatory requirements.
5. Customs Clearance: NHPs imported into Canada must go through customs clearance procedures. You may need to provide documentation to customs authorities, including commercial invoices, certificates of origin, and import permits.
6. Compliance with Regulations: Ensure that the imported NHPs comply with all relevant regulations and guidelines established by Health Canada, including those outlined in the Natural Health Products Regulations.

Yes, Site Licenses for Natural Health Products (NHPs) in Canada do expire. Site Licenses are typically issued for a specific period, usually one to three years.

To maintain compliance and continue manufacturing or distributing NHPs, companies must renew their Site Licenses before they expire. Renewal usually involves submitting updated documentation to Health Canada, demonstrating continued adherence to Good Manufacturing Practices (GMP) and other regulatory requirements. It’s essential for companies to keep track of their Site License expiration dates and initiate the renewal process in a timely manner to avoid disruptions in their operations. Failure to renew a Site License before it expires can result in regulatory non-compliance and may lead to enforcement actions by Health Canada, including suspension of manufacturing or distribution activities.

The process for renewing your Site License involves several steps. You will need to review the renewal requirements specified by the regulatory authority, prepare and update any necessary documentation, submit a renewal application, and possibly undergo a compliance verification inspection. Once your application is submitted and processed, you will await approval from the regulatory authority. If approved, you will receive a new Site License with an updated expiration date. It’s important to start the renewal process well in advance of your current Site License expiration date to ensure a smooth transition and avoid any disruptions in your operations.