Non-prescription Drug Action Plan
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About the action plan
Health Canada is committed to simplifying market access for non-prescription drugs.
As a first step, we developed the Non-prescription Drug Action Plan. This action plan advances the concepts of the self-care framework. The framework is part of our plans to reduce burden where possible and align the level of oversight of non-prescription drugs based on their level of risk.
The action plan introduces policy and operational solutions to remove barriers for getting non-prescription drugs to market. The Non-prescription Drug Action Plan excludes:
As is the case with many regulators globally, the COVID-19 pandemic caused delays to our regulatory plans. These plans include a proposal to amend the Food and Drug Regulations related to simplifying market access for non-prescription drug products.
Learn more about:
- Self-care framework
- Regulatory proposal
- Next steps on the self-care products initiative
- What’s New: Natural and non-prescription health products
Policy and operational approach
Through the action plan, we are proposing a number of policy and operational solutions, which will be aligned with the principles of the self-care framework. These do not require regulatory changes.
These solutions will expedite market access for non-prescription drugs by:
- removing repetitious and onerous requirements
- introducing flexibilities for industry
The solutions will not affect the health and safety of people in Canada who rely on these products.
Health Canada will implement the solutions in 3 phases:
- short-term solutions (starting December 2022)
- medium-term solutions (starting June/July 2024)
- long-term solutions (targeting end of 2024)
As we implement each solution, we will be updating the action plan. We will also be providing additional information (for example, in the form of notices and updated guidance documents).
Short-term solutions
- Solution 1 – Notice to stakeholders: Optional Canadian Drug Facts Table subheadings for non-prescription drugs
- Solution 2 – Notice to stakeholders: Additional guidance on product monograph and patient medication information leaflet for non-prescription drugs
- Solution 3 – Notice to stakeholders: Additional guidance for label mock-up requirements for non-prescription drugs
Medium-term solutions
- Solution 4 - Notice to stakeholders: Clarifying Post-Authorization Requirements for Quality-related Changes to Non-prescription Drugs
- Solution 5 - Notice to stakeholders: Clarifying NPD inactive ingredient policies
- Solution 6 - Notice to stakeholders: Application of INCI® names on NPD labelling
- Solution 7 - Notice to stakeholders: Development and release of Non-prescription Drug Cough, Cold and Flu Labelling Standard
Long-term solutions
Work is under way to advance long-term solutions. We will publish notices about this work once it is completed.
Related links
General:
Information on regulations: