The Good Manufacturing Practices Guide for Natural Health Products (GUI-0158) version 4 has just been released and posted on Heath Canada’s website under the Site Licensing Bulletin page (SL Bulletin No. 7) located here.
Here are the pdf copies of the French & English.
IMPORTANT TAKE-AWAY: It is imperative for importers to ensure sites located outside of Canada are informed of these changes. We suspect domestic manufacturers, packagers and labellers would have received the notice as they should have Site Licences, but you may wish to check.
Health Canada has released the following information associated with their announcement in case you have not received it individually:
About the publication
On Septembre 4, 2025, Health Canada published the following guidance document:
The updated guidance follows a 60-day consultation period that took place Octobre 15, 2024 to Décembre 16, 2024. We reviewed the feedback from stakeholders and implemented changes where applicable.
Learn more about the consultation process here:
This revised guidance document contains new information to make the document clearer and align with current industry practices. This guidance takes effect Mars 4, 2026.
Overview of key changes
Version 4.0 of the guide reflects Health Canada’s commitment to modernizing regulatory guidance and:
- includes helpful notes and tips throughout
- was reorganized to follow the order of the regulations
- uses clear, user-friendly language and accessible formatting
- aligns guidance with the Quality of natural health products guide
- incorporates guidance on records, GDP, and SOPs for better flow and clarity
- includes an updated risk classification section aligned with appropriate risk levels
This new version provides additional guidance on:
- CAPA plans
- quality agreements
- translating GMP records
- quality assurance systems
- developing a stability program
- recall systems and mock recalls
- cleaning and sanitizing equipment
- maintaining relevant GMP evidence
- equipment suitability and calibration
- water supply and distribution systems
- deviations and out-of-specifications (OOS)
- batch records and certificates of manufacture
- contract manufacturers and outsourcing activities
- electronic signatures and records and data integrity
- roles of senior management, consultants, QAP and designates
- transporting, storing, sampling and testing materials and products
- requirements for importers of homeopathic medicines and sterile products
- reduced and rotational testing, testing exemptions and quantification by input (QBI)
Transition period
The transition period is 6 months: Septembre 4, 2025 to Mars 4, 2026. During this time, you are encouraged to refer to the new version of the guide and to adjust your procedures as applicable. Version 3 of the guide will remain available and in use by Health Canada until Mars 4, 2026 at which time it will be removed.
Contact us
If you have questions, contact the Natural Health Products Licensing and Inspection Division of the Regulatory Operations and Enforcement Branch by email: hpcd.nhp.sl-dcps.psn.le@hc-sc.gc.ca.
