Notice to stakeholders: Development and release of non-prescription drug Cough, Cold and Flu labelling standard

March 2025

In advance of a regulatory proposal amending the Food and Drug Regulations to simplify market access for non-prescription drug products, Health Canada has developed a Non-prescription Drug (NPD) Action Plan. This Action Plan aims to reduce burden where possible and to align the level of oversight of NPDs based on their level of risk. This Action Plan introduces policy and operational- based solutions to remove barriers for getting NPDs (excluding ethical drugs, controlled substances, and biocides) to market.

Through this notice, Health Canada is announcing the publication of a Non-prescription Oral Adult Cough, Cold and Flu Labelling Standard (CCF LS). The CCF LS captures single and multi-ingredient orally administered non-prescription products for use in adults (12 years and older) to provide relief of symptoms associated with the common cold. A draft version of the CCF LS was released for consultation in Spring 2024.

Information Resources

Guidance document: Non-prescription Oral Adult Cough, Cold and Flu Labelling Standard

Contact Information

Questions can be sent to:
Email: nnhpd-dpsnso@hc-sc.gc.ca