Will Health Canada assess the qualifications of a Third Party Auditor independent of a site licence application?
No, Health Canada will not assess the qualifications of a Third Party Auditor independent of a site licence application. Health Canada will only assess the qualifications of a Quality Assurance Person referred to under sections 28(f) or 51 of the Natural Health Products Regulations with a complete site licence submission. The assessment will be based on the education/technical knowledge, training and experience of the Quality Assurance Person for performing a site licence audit against the good manufacturing practices outlined in Part 3 of the Natural Health Products Regulations for the activities and products stated in the site licence submission. A complete site licence submission includes a site licence application form, a quality assurance report, a quality assurance person qualification form and, where appropriate, a supplementary quality assurance form for homeopathic medicine and a designated third party authorization form.
