Cosmetics Alliance has been informed by the Natural & Non-prescription Health Products Directorate (NNHPD) that major changes are coming to the Product Licence Application (PLA) process for Class II and III Natural Health Products (NHPs).
These changes are being introduced to address the current backlog and will focus on:
- Reducing workload for both applicants and NNHPD staff
- Accelerating application processing
- Expanding eligibility under the “to be sold and/or manufactured in Canada” provision
This update is significant and will affect all member companies involved with NHPs, including those:
- Holding existing NHP authorizations
- Planning to submit a PLA
- With applications currently in the queue
NNHPD will release full details shortly. CA will notify members immediately upon issuance of the formal notice, expected later this week. We understand NNHPD will implement a pause in processing NHP applications from December 1 to 15 to deploy these changes.
As you are aware certain changes to the PLA must be notified within 60 days of making the change. To accommodate the planned downtime of the Web PLA and Amendment and Notification Form (ANF) flexibility will be provided, allowing changes made between October 2 and October 16, 2025, to be notified within two weeks of the forms being back online.
These developments represent an important first step in reducing regulatory compliance burden (‘Red Tape Reduction Commitments’) and an important first step to simplifying the regulatory application (workload management) process, by limiting the number of administrative forms to be completed by product sponsors. These developments will also serve to reinforce and support CA’s broader strategic objective to transition cosmetic-like drugs and NHPs (as defined in the CUSMA Cosmetics Annex) to an enhanced cosmetic regulatory framework with post-market oversight. This approach would provide a more appropriate pathway for low-risk products while significantly reducing NNHPD’s workload, as CA has formally raised with NNHPD officials.
Be on the look out for NNHPD’s formal communication announcing these developments and our follow-up communiques highlighting greater details to come.
