Refusal criteria applied to submissions for a site licence and foreign site reference number
NHP Site Licensing Bulletin No. 4, December 21, 2022, from the Natural and Non-prescription Health Products Directorate
On this page
- At a glance
- Purpose and scope
- Refusal criteria (applied at screening)
- Risk-based GMP refusal criteria (applied at assessment)
- Implementation
- Contact us
At a glance
- The Natural and Non-prescription Health Products Directorate (NNHPD) will refuse submissions based on the administrative and good manufacturing practices (GMP) deficiencies presented in this bulletin.
- Starting March 21, 2023, the refusal criteria will apply to all site licence (SL) and foreign site reference number (FSRN) submission types, such as:
- new applications
- amendments or modifications
- notifications
- renewals or GMP evidence updates
Purpose and scope
Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD) continuously strives to increase process efficiencies. This applies to processing, screening and assessing SL and FSRN submissions.
This bulletin provides information on the types of deficiencies that will result in the refusal of a submission. Except where stated, these deficiencies apply to all SL or FSRN submission types filed with the directorate.
Submissions that do not meet the administrative needs and/or requirements of the Natural Health Products Regulations (NHPR), including section 28 (application requirements) and Part 3 (GMP) will be refused. Unless otherwise noted in the following sections, the NNHPD will not issue an information request notice (IRN) before refusing the submission.
Only sites with deficiencies will be refused, and not the entire submission, unless the site in question forms the basis of the SL (for example, the Canadian importer site). These include deficiencies identified during screening and GMP compliance deficiencies identified during assessment.
The objective of this bulletin is to encourage the submission of complete and high quality applications as they will:
- help the NNHPD meet performance targets
- enable the NNHPD to prioritize submissions that are complete (less time spent obtaining unclear, missing or basic information)
- improve the quality of submissions over time to facilitate efficient reviews
Learn about submission deficiencies in section 3.1.3 of the Site licensing guidance document.
Refusal criteria (applied at screening)
SL and FSRN submissions
We will refuse SL and FSRN submissions based on the following criteria:
- submission is not received through the ePost Connectâ„¢ Applications thread for the relevant company
- recommended subject line format: "##### - New NHP Applications Conversation"
- web SLA form is missing or not finalized
- web SLA form has a duplicate tracking number (the same tracking number is generated when applicants reuse the form by clicking the "Modify in response to an IRN" button; this interferes with our IT systems)
- old version of the application form is used
- for example, PDF of paper form, old version of web SLA form
- company code or SL number on the web SLA form is incorrect
- submission is missing relevant information
- for example, applicant contact, Canadian/foreign site, warehouse or activity information
- requirement is met when the web SLA form is successfully completed
- for example, applicant contact, Canadian/foreign site, warehouse or activity information
- applicant's company name, address or senior official information does not match our records and no notification submission was received
- excludes typos, acronyms and formatting changes
- regulatory requirement (section 33 of the NHPR) is to notify us of changes to this information
- Designated Party Authorization (DPA) Form is missing (if applicable)
- a DPA form is necessary for anyone other than the senior official or the primary user denoted in the trading partner agreement or profile, regardless of whether they are employed by the same company
- this is outlined in NHP Site Licensing Bulletin No. 3
- renewal application was not submitted at least 30 days before the licence expired
- renewal application was submitted but no activities took place in the past 12 months
- for example, the company did not perform operations in the past 12 months and therefore has no relevant records to demonstrate GMP compliance
- a one-time exemption will be made for SL holders on a 1-year renewal cycle
- amendment application for an expired SL was submitted
- supporting GMP evidence was not provided
- missing records or documents as per the documentation checklist in the web SLA form
- when activities have not yet begun and records are not yet available, templates must be submitted in all instances where records are requested in the documentation checklist
Other criteria upon which we will refuse an application also include the following:
- quality assurance report, summary of net changes or supplementary quality assurance report is unsigned, expired or incomplete
- for example, sections or questions are left blank
- pre-cleared evidence is unacceptable or expired
- includes incorrect company or address, unacceptable inspection scope, requested activities that are not covered and/or the regulatory authority is not a member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) or does not have a mutual recognition agreement (MRA) with Canada
- documents are not provided in 1 of Canada's official languages (English or French)
- include complete, legible and high-quality translations as needed
- we recommend a certified translation to avoid processing delays or submission refusal
- submission contains damaged or corrupted files
- submission format and structure are incorrect (set out in NHP Site Licensing Bulletin No. 3)
IRN responses
We will refuse IRN responses based on the following criteria:
- response is not received through the ePost Connectâ„¢ Correspondence thread for the relevant submission
- subject line format: "##### - SL ApplicationType-######-Review Conversation"
- response is late (includes extension if requested and approved)
- response is incomplete
- for example, does not address each of the deficiencies listed by either providing the requested documents or responding with a written rationale or explanation
- documents are not provided in 1 of Canada's official languages (English or French)
- include complete, legible and high-quality translations as needed
- we recommend a certified translation to avoid processing delays or submission refusal
- submission format and structure are incorrect (set out in NHP Site Licensing Bulletin No. 3)
Risk-based GMP refusal criteria (applied at assessment)
GMP non-compliance will result in refusal.
Appendix 5 of the NHP Good manufacturing practices guidance document describes the risk classification of GMP observations. It also explains each risk category (risk 1 as critical, risk 2 as major and risk 3 as other or minor) within each GMP area (places, people, processes and products).
We will refuse SL and FSRN new applications, amendments and renewals (unless otherwise stated) based on the following criteria:
- compliance with 1 or more sections of Part 3 (GMP) of the NHPR is/are not demonstrated
- one or more risk 1 observations is/are identified for new applications and amendments
- renewal submissions will receive an IRN
- one or more repeated risk 2 observations is/are identified
- observations made on the last issuance letter are not corrected
- submission contains evidence that unlicensed products were imported or manufactured for the Canadian market
- standard operating procedures (SOPs) do not meet the expectations outlined in Appendix 4 of the NHP Good manufacturing practices guidance document
Implementation
The SL and FSRN submission refusal criteria introduced in this bulletin will take effect on March 21, 2023.
Contact us
For inquiries about this bulletin, please contact us by email: nnhpd-dpsnso@hc-sc.gc.ca.
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