The Natural and Non-prescription Health Products Directorate (NNHPD) has published a new bulletin on finished product specifications for natural health products.
Effective Juin 25, 2026, NNHPD has updated its process to remove the requirement for applicants and licence holders to submit finished product specifications (FPS) when filing:
Class II and Class III product licence applications (PLAs) and amendments.
This process change aligns Class II and III applications with the existing framework for Class I applications, streamlining the licensing process and reducing administrative burdens while remaining appropriate to product risk levels.
Under this new model, changes made solely to an FPS no longer require an amendment or formal notification to Health Canada. However, it is still expected of stakeholders to maintain and ensure that their FPS comply with the current Quality of Natural Health Products Guide.
Furthermore, Health Canada retains the authority to request an FPS at any time, including via an Information Request Notice (IRN) during application reviews to address specific risk- or quality-related issues, such as those involving cannabis-containing products. This operational adjustment strictly alters the submission process and does not impact existing Natural Health Products Good Manufacturing Practices (GMP) requirements.
