_edited.png)
Responsible Person
for Canada
With the implementation of Amendment SOR/2024-63, effective April 2024, the definition of "Manufacturer" in the Cosmetics Regulations was expanded to include the designation of a "Responsible Person." This is a representative established in Canada, authorized to act on behalf of foreign companies and assume legal responsibilities related to regulatory compliance.
What is the Responsible Person for Canada?
The "Responsible Person" is a legal entity introduced by the Canadian government under the regulation of consumer products and cosmetics. This role ensures that products distributed in the Canadian market comply with current regulations, promoting consumer safety and transparency in the industry.
Importance of the CRP (Canada Responsible Person)
The implementation of the "Responsible Person" is part of the new Canadian regulations that seek to:
-
Ensure compliance with labeling, composition, and safety laws.
-
Facilitate direct communication with authorities in the event of inspections or audits.
-
Provide a point of contact in Canada to answer questions from authorities or consumers.
Who can be a PR in Canada?
The "Responsible Person" can be:
-
A natural or legal person established in Canada.
-
An authorized representative acting on behalf of the foreign manufacturer or distributor.
General Duties and Responsibilities of the Responsible Person in Canada
01
Regulatory Compliance
Ensure that products comply with current regulations:
-
For medical devices: Comply with the Medical Devices Regulations (SOR/98-282).
-
For drugs and biological products: Comply with the Food and Drugs Act and its regulations.
-
For cosmetics: Ensure compliance with the Cosmetic Regulations.
Verify the technical compliance of products with labeling, packaging, and acceptable ingredient requirements.
02
Registration and Licensing
Manage the licenses and notifications required by Health Canada:
-
Medical Device Licensing (MDL).
-
Cosmetic Product Registration (CNS).
-
Applications for approval of new or generic drugs.
Supervise the import/export activities of health products.
03
Risk and Safety Assessment
-
Monitor product safety on the market.
-
Be aware of adverse incident reports and take proactive measures.
-
Submit post-market surveillance reports, such as Mandatory Problem Reports (medical devices) or Adverse Reaction Reports (medicines).
-
-
Implement corrective actions in case of quality or safety issues, such as product recalls.
04
Representation before Health Canada
Act as the official point of contact between the company and Health Canada:
-
Facilitate audits, inspections and provide requested documentation.
-
Respond to regulatory inquiries and requests for information from authorities.
05
Quality Management
Establish and maintain a quality management system:
-
Verify that the manufacturing, storage and distribution processes are compliant.
-
Ensure that manufacturers (including international ones) comply with Good Manufacturing Practices (GMP).
06
Training and Supervision
Train staff in applicable regulatory requirements.
Oversee operations related to quality, importation, distribution, and handling of products.
07
Communication of Significant Changes
-
Notify Health Canada of any significant changes in the manufacturing, composition, or documentation of the products.
-
Ensure that distributors and partners are aware of legal and operational requirements .
08
Coordination of Market Recalls
Develop and implement a plan for recall management.
Oversee the recall of products that pose a risk to public health or violate regulations.
With over 10 years of experience in safety assessments for cosmetics, food supplements, homecare products, and medical devices, BELAB SERVCES offers a comprehensive and reliable solution for effectively verifying and registering your products. Our solution, based on a deep understanding of the legislation, relies on a team of scientific consultants and advanced IT tools, makes it the fastest and most reliable route to entering the European market.
