Expectations for finished product specifications
Natural Health Product Licensing Bulletin No. 11, June 15, 2026
On this page:
At a glance
- Starting June 15, 2026, finished product specifications (FPS) no longer need to be submitted with Class II and III product licence applications (PLAs) and amendment applications.
- As a reminder, FPS do not need to be submitted with Class I PLAs and amendments, as outlined in the Natural Health Products Management of Applications Policy (December 2025).
Purpose and scope
This bulletin informs natural health product (NHP) applicants and licence holders of a change to the process for licensing NHPs by the Natural and Non-prescription Health Products Directorate (NNHPD). The intent is to reduce administrative burden in a manner that remains appropriate to the level of risk.
The process change removes the expectation that applicants and licence holders submit FPS with Class II and III PLAs and amendment applications. Licence holders are still required to establish and maintain FPS for their products and, upon request, provide that information to Health Canada.
Background
Class I applications already follow a model in which FPS do not need to be submitted with the application but must be kept on file and provided to Health Canada upon request.
This process change extends that approach to Class II and III applications, thus harmonizing the FPS approach across all NHP PLA classes.
Future amendments to the Natural Health Products Regulations will take this operational change into consideration.
Implementation
Beginning June 15, 2026, the following will apply:
- FPS submission no longer expected: Applicants and licence holders will no longer need to provide FPS at the time of filing Class II and III PLAs and amendments.
- FPS only changes become non-notifiable: Changes limited solely to FPS will no longer need an amendment, nor will they need notification to Health Canada. In other words, changes to FPS do not have to be submitted to Health Canada.
- FPS requests during application review: Health Canada retains the authority to request FPS for any NHP at any time. If FPS are required during a PLA or amendment review, they will be requested through an Information Request Notice (IRN). Such requests will be limited to risk‑related quality issues, such as cannabis‑containing NHPs. It is not possible to provide an exhaustive list, as such issues related to quality and risk may vary by submission and could vary as scientific knowledge and product innovation advance.
Regulated parties must continue to ensure that FPS:
- are established in accordance with the current Quality of Natural Health Products Guide;
- remain in compliance with the requirements described in that guide; and
- are provided to Health Canada upon request.
These expectations remain unchanged and are reiterated here for clarity.
This NHP product licensing process change also does not alter NHP Good Manufacturing Practices (GMP) requirements. Regulated parties must continue to meet all applicable GMP requirements as outlined in the Good Manufacturing Practices Guide for Natural Health Products (GUI-0158).
Contact us
For inquiries about this bulletin, please contact us by email: nnhpd.consultation-dpsnso@hc-sc.gc.ca.