Closed consultation: Draft guidance on the plain language labelling regulations for prescription drugs
Current status: Closed
This consultation ran from September 25, 2025 to November 7, 2025.
Health Canada sought 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Read the draft guidance for consultation.
Who was the focus of this consultation
We engaged with:
- industry
- health professionals
Key questions
Your input and ideas were sought to answer the following questions:
- Do you believe that specific sections or statements would benefit from greater clarity (if so, please identify)?
- Do you have additional suggestions for examples of Level III changes to propose for consideration?
- Do you wish to share any other general suggestions or questions for consideration?
Related information
Contact us
Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada