Health Canada’s NNHPD hosted various trade associations, including CA, in a session on March 30 to present their proposed OTC Drug Action Plan and seek feedback to inform further development of the plan. In attendance for Cosmetics Alliance were Beta Montemayor and Richard Parcels. This initiative follows CA’s request for further interim relief measures in light of the delays in finalizing the Self-Care Framework due to the pandemic.
NNHPD informed attendees that their focus at this early stage is to define interim measures based on clear principles, and how to operationalize them will come at a later stage. Any interim measure will align with the principles of the Self-Care Framework, reduce administrative burden for industry, and maintain safety for Canadians. Interim measures must be within Health Canada’s “non-regulatory” or administrative authority as changes requiring amendments to regulations or legislation must be addressed through the formal amendment process.
NNHPD proposed the following interim measures and timeframes:
Short Term (Fall 2022)
• Flexibilities that simplify mock-up requirements for OTC PLL in certain situations
Medium-Term (Spring 2023)
• NMI Policy for OTCs, clarifying the purpose of the NHPID, integration of INCI for OTC NMIs
Long-Term (Fall 2023-Spring 2024)
• Foreign monograph integration policy
• Monograph modifications
• Human-Use Antiseptic Drugs Guidance Document Update
• Brand name assessment changes
• Division 8 alternative pathways
Cosmetics Alliance will be engaging in further discussions with the NNHPD and ROEB for outcome-based GMPs in the OTC space to advance flexibilities which are not hard-wired into GMP regulations. We will also be following up with our PCMA and FCM Committees in the next few weeks to discuss the proposed interim measures, understand which are priorities for our members, and how they might be best operationalized.
If you are not already a part of our PCMA or FCM Committees and are interested in joining, please don’t hesitate to reach out to your CA Regulatory Team at regulatory@cosmeticsalliance.ca
