Site Licence (GMP Certificate)
A site licence issued by the Natural and Non-prescription Health Products Directorate (NNHPD, a division of Health Canada) gives the licensee authorization to conduct the activities such as manufacturing, packaging, labeling and importing of natural health products.
Health Canada requires that all manufacturers, packagers, labellers, and importers of natural health products (NHP) be licensed. Sites must have procedures in place for distribution records and product recalls and for the handling, storage and delivery of their products. They must also demonstrate that they meet good manufacturing practice requirements.
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Who needs site licence?
A site licence is required for the physical site in Canada where any persons (business or individual) wish to manufacture, package, label, and/or import a NHP for sale.
How to obtain the site licence?
A Site Licence Application (SLA) requires the applicant to submit evidence of GMP compliance such as GMP certificate, Drug Establishment Licence, or a Quality Assurance Report (QAR) outlining their GMP program, along with examples of certain written Standard Operating Procedures (SOPs) and any associated forms or checklists to demonstrate the compliance to tGMP requirements.
The site licence application must be completed by a qualified QA person who meets the NNHPD’s minimum qualifications in education, training & experience, in order to protect the quality of the finished product.