As part of Health Canada’s initiative to update its approach to regulating self-care products, including non-prescription drugs (broadly, also including cosmetics and natural health products), and as a first step in advance of a regulatory proposal to simplify market access for non-prescription drug products, Health Canada has developed a Non-prescription Drug Action Plan.
The action plan introduces policy and operational solutions to remove barriers for getting non-prescription drugs (excluding ethical drugs, controlled substances, and biocides) to market, by removing repetitious and onerous requirements and introducing flexibilities for industry.
Short-term solutions were announced and effective December 2022, with updates relating to optional subheadings for the Canadian Drug Facts Table, product monograph and patient medication information leaflets, and label mock-up requirements. Medium- and long-term solutions are targeted for the end of 2023 and the end of 2024; Health Canada will publish further information once the work is completed, for example by way of notices.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.