Health Canada is seeking feedback on proposed revisions to the Questions and Answers: Plain Language Labelling for Prescription Drugs Guidance Document.
Revisions to the current guidance document have been proposed to:
- accommodate current style and format standards for web publication
- add more examples of what types of plain language labelling changes should be submitted for review and what are considered Level III – Annual/Post-DIN Notifications
- clarify the submission of second-language labelling materials
- remove reference to safety and efficacy NCs
- update guidance for abbreviated package inserts
Read the draft guidance for consultation.
Opened on September 25, 2025 and will close to new input on November 7, 2025.
