Site License Guidance

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A site licence is required for the physical site in Canada where businesses plan to manufacture, package, label or import natural health products (NHPs) for sale in Canada. Similar to a Drug Establishment License a site license confirms compliance of NHP supply chains with Canadian Good Manufacturing Practices.

The timelines  assigned by Health Canada for processing and review of site license applications are listed in Table 1 of the 2015 Site Licensing Guidance Document. Over the past few years there have been periods where reviews have taken longer than the established timelines. Given the current slow down associated with resource limitations and high application volumes, it is critical to submit a site license application that is not refused as that can result in unnecessary  delays.

In order to understand which deficiencies trigger a refusal, close attention should be paid to The Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletins. The criteria for a high quality submission covered in these bulletins are used by the Health Product Compliance Directorate to screen and assess site license applications, amendments and renewals.  

NHP Site Licensing Bulletin 3 outlines the required file format, file names and recommended structure of site license submissions. Specific file names and folder structure are addressed in this bulletin. Applicants should ensure these instructions are followed to avoid having their submissions refused.

Additionally, the following are considered significant administrative deficiencies that would result in immediate refusal:

  • failure to provide documents in English or French
  • failure to provide documents in the acceptable file types
  • failure to present information and evidence as individual files

NHP Site Licensing Bulletin 4 also provides examples of findings that may result in a refused application. Deficiencies may be detected during screening or during the scientific assessment of the file, which occurs after screening.  Some commonly seen deficiencies are listed below:

  • Good Manufacturing Practices (GMP) evidence is missing for one or more sites.
  • Documents required to demonstrate GMP compliance are missing, for example Standard Operating Procedures (SOPs) for finished product testing or product recall.
  • A Quality Assurance Report form is missing or is submitted with some sections left blank.
  • The Harmonized Site Licence and FSRN Application form, required with all transactions is missing information or hasn’t been finalized.
  • Standard operating procedures (SOPs) do not meet the expectations of Health Canada.

Site  licenses communication has transitioned from the ePost Connect system to LiquidFiles secure file transfer system.  Applications sent through the ePost system will not be processed or reviewed  by the Health Product Compliance Directorate.