Why Your Business Needs an EU Responsible Person under GPSR
As the European Union tightens its product safety regulations with the General Product Safety Regulation (GPSR), businesses must adapt quickly to avoid costly compliance failures. One key aspect of this new regulation is the requirement for non-EU manufacturers to designate an EU Responsible Person (RP) for their products. This role is crucial for companies looking to maintain market access and uphold product safety standards across the EU.
Understanding GPSR and the Role of the EU Responsible Person
The GPSR, which applies from December, mandates that almost all consumer products sold in the EU, including those sold online, must have a designated Responsible Person based within the EU. This individual or entity is accountable for ensuring that products meet EU safety standards and regulations. The role is similar to what’s required under the EU Market Surveillance Regulation, which governs CE-marked products.
The Key Responsibilities of the EU Responsible Person
The EU Responsible Person has several important duties, including:
Ensuring Product Safety Compliance: The RP must gather and maintain the EU declaration of conformity, ensuring all documentation is available for market surveillance authorities.
Handling Risk Management: The RP is responsible for informing authorities about any product risks and working with the manufacturer to resolve non-compliance issues, including product recalls or corrective actions.
Documentation Oversight: The RP ensures that all product-related documentation, such as safety warnings and technical information, is properly maintained and made accessible to regulatory bodies upon request
Communication with Market Surveillance Authorities: As the point of contact for regulatory bodies, the RP is critical for handling inspections and audits, helping maintain continuous compliance with EU regulations.
In addition, product labeling must now include the details of the Responsible Person, making it easier for consumers and authorities to get in touch if needed.
How AF Pharma Can Help
As a trusted partner for non-EU manufacturers, AF Pharma offers comprehensive EU Responsible Person services to ensure your business complies with the GPSR. By choosing us, you benefit from:
Expert Compliance Support: We help navigate the complexities of GPSR, ensuring your products meet all necessary regulations.
Ongoing Risk Management: We monitor and manage product safety risks, ensuring that you can take corrective actions quickly when needed.
Seamless EU Market Entry: With our EU Responsible Person services, you can confidently expand your business into the EU market without the worry of regulatory hurdles.
Ensuring Your Business Stays Compliant
By appointing AF Pharma as your EU Responsible Person, you gain access to a dedicated team of regulatory experts who will help you maintain product compliance, minimize risk, and foster consumer trust in the European market.
Ready to learn more about how our EU Responsible Person services can benefit your business? Contact us today and ensure your products meet the new GPSR requirements.
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