Effective March 10, 2023, Health Canada changed submission requirements for second-language product monographs for human drugs. This change no longer requires the second language product monograph at the time of submission filing or review. However, both English and French languages need to be on the Drug Product Database (DPD) online and Drug and Health Product Portal (DHPP).
What is included? Rx and over-the-counter pharmaceutical drugs, biologics and radiopharmaceuticals.
What is not included? Labels and package inserts.
It is also important to note that both English and French product monographs are required post-authorization without exception. While this updated requirement provides a cushion of time before the second language product monograph is required, it does not change the product monographs ultimately.
Health Canada has provided this chart for easy reference:
Health Canada is in the process of implementing regulations requiring labeling and listing to be submitted in XML PM (eXtensible Markup Language Product Monograph) format. Health Canada is currently accepting voluntary XML PM submissions and are “working hard to prepare the XML PM Guidance along with samples for public comment.”
We will provide more information about how these guidances will affect one another once it is available.