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Obtain a Site Licence or FSRN

Obtain a Site Licence or FSRN

To apply for a site licence, applicants must provide to the NNHPD, a site licence application which includes the following forms and documents:

  • Site Licence Application (SLA) Form: The Site Licence Application Form captures all of the information outlined in the GMP Regulations.
  • Designated Party Authorization (DPA) Form (when applicable): Applicants/licensees who have designated a third party person to file a submission with the NNHPD on their behalf must submit a Designated Party Authorization Form. 
  • Evidence of GMP compliance for each site. When NHPs are imported from foreign manufacturers, packagers and/or labelers, a foreign site reference number (FSRN) must be provided to demonstrate the GMP compliance of foreign sites.


How do we help you obtain the site licence and/or Freign Site Reference Number?

  • Help you assess your facility to assure it is in line with GMP requirements
  • Early involvement at the blueprint stage to assure the appropriate layout and renovation of your facility.
  • Help you establish and/or evaluate 4Ps' (Personnel, Premise, Process, and Products) Standard Operating Procedures (SOPs) to assure its completeness and GMP compliance.
  • Evaluate the documentation and records to make sure they are properly managed.
  • Train the QA person on site in order to meet the NNHPD’s qualifications for education, training & experience.
  • Complete the site licence application or FSRN application with supporting documents (QAR, GMP certificate, etc) and records.
  • Handle the request for further information & documentation from Health Canada after the application submission.
  • Assist you for the annual renewal after site licence approval.