Product Licensing Update
Health Canada has released an update for the Class III PLA performance standards. Additionally, the online Finished Product Specifications User Guide was updated to reflect the changes to the testing requirements introduced in 2015. See additional details below.
-
New performance standard for Class III product licence applications is 310 days (increase from 210 days). Applicants should expect delays in processing times and are encouraged to submit their applications at least a year prior to the product’s launch.
-
The online guide update includes the following changes:
elemental impurities: maximum daily values updated for lead, chromium IV, and for tolerance limits for topical products.
microbial contaminants: revised this to indicate limits are acceptable as per the referenced pharmacopoeias indicated limits.
quantity limits and testing requirements: updated to align with the Quality Guide.
marine and non-marine oils: update to the acceptable limits for oxidative stability (peroxide value or anisidine value), PCBs, PCDDs, and PCDFs.
contaminant testing: the applicable ingredient lists for various contaminants have been updated to provide more clarity about what triggers these testing requirements.
sterility of nosodes: for homeopathic products containing nosodes the sterility technique must comply with the sterility requirements outlined in (Homœopathic Pharmacopœia of the United States) HPUS or Homöopathisches Arzneibuch (HAB). (Please note: this information is not included in the Quality of NHPs guide).
(The changes to the testing requirements were implemented in 2015, but the online guide was updated in December 2022).
Unsure what testing requirements must be met for your product? Reach out to our team today for help.
Follow us on LinkedIn