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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 IN 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 PR IN CANADA
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 AN RP 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
Evaluación de Riesgos y Seguridad
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Monitorear la seguridad de los productos en el mercado.
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Estar al tanto de informes de incidentes adversos y tomar medidas proactivas.
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Presentar informes de vigilancia postmercado, como los Mandatory Problem Reports (dispositivos médicos) o Adverse Reaction Reports (medicamentos).
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Implementar acciones correctivas en caso de problemas de calidad o seguridad, como retiros de producto.
04
Representación Ante Health Canada
Actuar como punto de contacto oficial entre la empresa y Health Canada:
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Facilitar auditorías, inspecciones y proporcionar documentación solicitada.
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Responder a consultas regulatorias y solicitudes de información de las autoridades.
05
Management
quality
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.
Monitor the recall of products that pose a risk to public health or violate regulations.
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