Description - Appendix E – Site licensing process map

As of September 2007, there are three aspects to the natural health products site licensing process:

• The process for products manufactured in Canada;
• The process for products manufactured at foreign sites;
• Site licence renewal.

The site licensing process for a product manufactured in Canada is as follows:

• The applicant applies for a site licence by mail. The applicant must provide the following documentation: the site licence application form; the quality assurance report form; the supplementary quality assurance report form; and the designated party authorization form.
• The application is verified for administrative information and is assigned a file number and a submission number.
• The Natural and Non-Prescription Health Products Directorate (NNHPD) then issues an acknowledgement notice to confirm reception of the application package.
• The application is checked for completeness. At this point, there may be some back and forth between the applicant and NNHPD in order to resolve any minor deficiencies.
• A decision is made regarding the application. The applicant then has 30 calendar days to request reconsideration of the application.
• If the reconsideration decision is still negative, a final notice is sent to the applicant, describing the reasons for the refusal.

The site licensing process for a product manufactured at foreign sites follows the same process as licensing for a product manufactured in Canada. However, the Canadian importer is responsible for the application and must provide the following additional documentation: a quality assurance report; a certificate of compliance; the most recent inspection report by a qualified authority; the corporate audit report; other relevant reports such as ISO 9001 or WHO inspection reports.

The first licence given expires after one year. Renewal is every year for the first three years, every second year for the subsequent three renewals, and every third year thereafter.

The site licence renewal process is as follows:

• NNHPD sends a renewal package to the site licence holder at least 60 days prior to expiry.
• The applicant must provide the following documentation within 30 days of receipt of the renewal package: the quality assurance report form for every third renewal; the renewal notice; the renewal summary report; the summary of net changes form.
• The application for renewal is evaluated and further information is requested as needed.
• A decision is made regarding the renewal of the site licence. Unless there are significant changes, renewal is usually granted.