As of March 21, 2023, the Natural and Non-prescription Health Product Directorate (NNHPD) began applying new refusal criteria against Site Licence (SL) and Foreign Site Reference Number (FSRN) submissions, as outlined within Site Licence Bulletin No. 3 and Site Licence Bulletin No. 4.
Purpose & Scope
The refusal criteria apply to all Canadian manufacturers, packagers, labellers, and importers of natural health products applying for, renewing, or amending a Site Licence (SL) or a Foreign Site Reference Number (FSRN). The refusal criteria also apply to Information Request Notices (IRNs) issued to the SL holder from the NNHPD.
Site Licence Bulletin No. 3
Site Licence Bulletin No. 3 outlines the format and structure requirements when applying SLs and FSRNs. These requirements are as follows:
- Applications must have a cover letter
- Applications must use a DPA form to designate a third-party filing
- Applications must follow file naming and formatting conventions
- Applications must submit only necessary information, such as only one supporting GMP evidence piece per site
- Applications must complete the product information section of the web SLA form
Failure to meet these requirements will lead to an SL and FSRN issuance refusal
Site Licence Bulletin No. 4
Site Licence Bulletin No. 4 focuses specifically on deficiencies that could result in the refusal of an SL or FSRN application.
Refusal Criteria Applied at Screening for SL & FSRN Submissions:
- Submissions not received through ePost Connect applications thread
- Web SLA is missing information, or has a duplicate tracking number (happens when reusing an existing form for a new application)
- The old version of the application form is used
- The company code or SL number is missing or incorrect
- Relevant information is missing from submission (e.g. applicant contact, Canadian/foreign site information)
- Company information is incorrect or does not match Health Canada’s records
- The DPA form is missing
- Renewal application was not submitted at least 30 days prior to licence expiry date
- A renewal application was submitted but no activities took place in the last 12 months
- An amendment application for an expired SL was submitted
- Supporting GMP evidence was not submitted as part of the web SLA form
Refusal Criteria for IRN Responses:
- The response is not received through ePost Connect correspondence threat
- The response is late
- The response is incomplete
- The response is not provided in one of Canada’s official languages (English or French)
- The submission format and structure are incorrect (follow NHP Site Licensing Bulletin No. 3)
Refusal Criteria for GMP Evidence Submissions (Applied at Assessment):
- Compliance with 1 or more sections of Part 3 of the NHPR not demonstrated
- One or more risk 1 observation is identified
- One or more repeated risk 2 observations are identified
- The submission contains evidence that unlicensed products were imported or manufactured for the Canadian market
- Standard operated procedures do not meet expectations outlined in Appendix 4 of the NHP Good Manufacturing Practices guidance document
How to be Prepared
Because the SL & FSRN refusal criteria are already in effect, they will have an immediate impact on all SL & FSRN applications. We recommend reviewing both SL bulletins No. 3 & No. 4 in detail prior to applying for, renewing, or amending a Site Licence (SL) or a Foreign Site Reference Number (FSRN). For added assurance, we recommend having your submissions reviewed prior to filing with NNHPD.
For more information about this, or any other regulatory affairs matters, please get in touch with us using the contact form below.