What improvements are being made to support NHP site licensing?
Internal template updates support: consistency between reviews-Fall 2023
Increased efficiencies in Site Licensing-Summer/Fall 2022Continue risk-based administrative renewals.
Looking to provide advance notice to lighten the burden of application and working with ROEB on leveraging inspection ratings
Targeted updates to FPS User Guide*-December 15, 2022 -Test parameters added; changes to tolerance limits; changes to parameters applied to specific ingredients in alignment with the Quality of Natural Health Products Guide
Site Licensing Bulletins–#3 and #4, effective March 21, 2023
Risk-based criteria for quality amendments-Spring 2023 Quantity tolerance limits exceeding the Prescription Drug List or Cosmetic Ingredient Hotlist, or missing an upper or lower limit
Guidance updates (Quality guide, GMP Guidance Document)-Consult Fall 2023
Tips to support NHP site license applications:
·Read Site License Bulletins-bulletin#3 (format/structure) and#4 (refusal criteria) are implemented as of March 21st & apply via the right channel
·Provide evidence for products that are intended for the Canadian Market
·Respond to an information request notice (IRN) on time (e.g., multiple requests for extensions)
·Monitor your email, including junk mail, for a notification from the ePostConnect System so you do not miss IRNs or licensing decisions.
To submit a complete and compliant application, e.g., follow the Web SLA checklist with no missing records, legible documents, or English or French documents.
NHP Site License Renewal Tips:
Apply to renew the site license at least 30 days before the permit expires.
Submit only an application to renew a site license (i.e., requests for modifications like adding a new foreign site must be submitted as amendments).
Submit a complete summary of net changes (SNC) from records 1–8 (storage, pest control, training, sanitation, finished product testing, QA release, recall, and stability) within 12 months.
If renewal is missed, a company that has previously conducted activities should submit SNC rather than QAR.
Per Bulletin #4, there is a one-time exemption not to provide evidence if no activities have been conducted for 12 monthsA site license is only needed for those performing activities, so if you’re not conducting activities beyond this, it is recommended to relinquish the site license and reapply in the future when you are ready.
NNHPD Inspections Update:
The new NNHPD will improve stability while being compliant with the Government of Canada’s Web Content Accessibility Guidelines (WCAG). The NNHPD is supporting colleagues in ROEB in their inspection work.
- The focus is on reinspecting those considered non-compliant during the pilot and new inspections.
- Similar criteria to those used during the pilot, with some exceptions regarding COVID restrictions no longer being in effect and scope (no longer limited to importers and manufacturers)
The NNHPD is exploring leveraging inspection ratings during the site license review. Click here to see the NHP GMO Inspection pilot results.
How Quality Smart Solutions can help
At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.