All companies located in Canada that manufacture, label, package or import natural health products must hold a site license approved by the Natural Health products Directorate (NHPD). Sites must have procedures in place for product manufacture, storage, handling and distribution of natural health products. They must also adhere to Good Manufacturing Practices (GMPs) to ensure product safety and quality as specified in the Natural Health Product Regulations. Specifically, companies must employ standard operating procedures (SOPs) which outline standards and practices in 12 key areas including product specifications, premises, use of equipment, qualification of personnel, sanitation, operations, quality assurance, product stability, records retention, sterile manufacturing, lot or batch samples and recall reporting.

Foreign sites and foreign distributors do not need a site license but they must adhere to GMP.

To apply for a site license, applicants must submit two forms to the NHPD: a site license application form and a quality assurance report which assesses the company’s compliance with GMP.

Imperia is able to assist NHP companies to obtain a site license and achieve regulatory compliance in 5 ways:

1. Review and report on the status of the company’s GMP compliance in 12 key areas. Deficiencies will be identified and corrective action recommended.
2. Assist the company to obtain or write Standard Operating Procedures, as required.
3. Draft and file the Site License Application with NHPD on behalf of the client. The application contains two reports: the Site License Application Form and the Quality Assurance Report (or equivalent).
4. Provide GMP training on-site and set up a staff training record system.

Communicate with the NHPD during the entire “Assessment Process” and collaborate with the client in responding to any further NHPD requirements in a timely manner.