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.