The Natural Health Products Site Licensing and Good Manufacturing Practices Inspection Bulletin
The Health Product Compliance Directorate in the Regulatory Operations and Enforcement Branch oversees site licensing and good manufacturing practices inspections for natural health products in Canada.
A site licence is required for the physical site in Canada where a business or individual manufactures, packages, labels or imports a natural health product for sale. To obtain and keep a site licence, regulated parties must comply with GMPs for each site. These requirements are set out in Parts 2 and 3 of the Natural Health Products Regulations.
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To promote compliance with regulatory requirements, we provide guidance on site licensing and good manufacturing practices for natural health products. One of the ways we do this is through regular bulletins. These bulletins contain information on site licensing changes and remind stakeholders of their regulatory obligations.
The following table lists all of the bulletins that we have sent out to date. If there's a specific bulletin that you can't find or access, you can ask for a copy by emailing us at hpcd.nhp.sl-dcps.psn.le@hc-sc.gc.ca. Be sure to give us the bulletin number, date and title of the bulletin you would like to receive.
Check back often for new content. We will notify site licence holders by email when there is a new bulletin.
If you have questions about site licensing for natural health products, email us at hpcd.nhp.sl-dcps.psn.le@hc-sc.gc.ca.
For inquiries about good manufacturing practices inspections for natural health products, email us at hpcrm.nhpinspection-inspectionpsn.cpsgr@hc-sc.gc.ca.
| Bulletin number | Title | Date |
|---|---|---|
| 6 | How to develop a corrective and preventive action plan (CAPA) | 2024-09-27 |
| 5 | Transition of natural health product site licensing activities | 2024-09-11 |
| 4 | Refusal criteria applied to submissions for a site licence and foreign site reference number | 2022-12-21 |
| 3 | Format and structure of submissions for a site licence and foreign site reference number | 2022-12-21 |
| 2 | Announcing version 3.0 of the Harmonized Site Licence and FSRN Application Form (Web SLA) | 2022-04-29 |
| 1 | Foreign Site Reference Number (FSRN) interim measures | 2022-04-26 |
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