New Requirement: Canadian Agent Now Mandatory for Cosmetic Notification Forms (Effective March 1, 2025)
Information for a designated Canadian Agent:
- Full name
- Civic (physical) address
- Email address
- Phone number
Who is a Canadian Agent?
A Canadian Agent is a person or entity residing in Canada who acts as the official point of contact for Health Canada regarding the notified cosmetic. While the Canadian Agent does not bear responsibility for product compliance or safety, they must be capable of:
- Receiving and responding to regulatory correspondence
- Facilitating communication between Health Canada and the foreign notifier
Why This Requirement Has Been Introduced
Health Canada’s intent with this requirement is to ensure:
- A reliable and accountable contact is available within Canada
- Efficient regulatory communication, particularly during inspections, compliance reviews, or enforcement actions
Labeling & Notification Considerations
- The Canadian Agent’s information must be included in the CNF.
- Their address is not required on the product label, unless they are also acting as the importer or distributor.
Impact on Previously Submitted CNFs
- CNFs submitted before March 1, 2025, remain valid and are not retroactively impacted.
- However, any amendments or updates made to such CNFs after the effective date will require the designation of a Canadian Agent.
Consequences of Non-Compliance
Failure to comply with the Canadian Agent requirement may result in:
- Rejection of the Cosmetic Notification Form
- Prohibition of the sale of the product in the Canadian market
How MCS Associates Can Support You
MCS Associates is an internationally respected regulatory affairs consulting group, proudly serving clients in the North American market for over 40 years. We specialize in delivering pragmatic and cost-effective regulatory solutions, with a deep commitment to responsiveness and results.
As part of our core competencies, MCS Associates can help interpret Health Canada guidance documents to assess their impact on companies engaged in the manufacturing, packaging, labeling, importation, and distribution of cosmetic products.
Our cosmetic regulatory experts can support your team with:
- Being your Canadian agent.
- Technical studies for product reformulation and development
- Product and facility registration
- GAP assessments of your current quality management system
- Implementation of robust risk assessment strategies
- GMP audits and internal compliance reviews
- Customized training for regulatory and quality personnel
- Direct communication and submissions to regulatory authorities
- Support with product stability programs and analytical testing
To learn more or to request regulatory or quality support, please contact us at: enquiries@mcs-associates.com
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