Navigating Amazon's Requirements to Sell in the EU: How AF Pharma Can Support Your Success
Selling on Amazon in the European Union offers immense opportunities for businesses to tap into a diverse and lucrative market. However, meeting Amazon’s stringent requirements can be challenging, especially for companies in regulated industries like medical devices, cosmetics, and dietary supplements. This blog outlines the key requirements for selling on Amazon in the EU and highlights how AF Pharma's specialized services can streamline your compliance journey.
Key Amazon Requirements for Selling in the EU
Amazon enforces strict guidelines for sellers to ensure compliance with EU regulations and to maintain customer trust. Below are the primary requirements for entering this market:
1. Business Documentation
To sell on Amazon in the EU, you must provide:
A valid VAT (Value Added Tax) registration for applicable countries.
Proof of business registration or a valid trade license.
2. Product Compliance
Products must comply with the EU’s regulatory frameworks:
Medical Devices:Â Must adhere to the Medical Device Regulation (MDR 2017/745). This includes a valid CE Mark and documented clinical evaluation reports.
Cosmetics:Â Require compliance with the EU Cosmetics Regulation (EC No 1223/2009), including product safety reports and a designated Responsible Person in the EU.
Dietary Supplements:Â Must comply with Directive 2002/46/EC, including proper labeling and safety assessments.
3. Labeling and Packaging
EU regulations mandate specific labeling standards:
Labels must be in the language of the target market.
Include mandatory details, such as CE marking for medical devices, ingredient lists for cosmetics, or nutritional information for dietary supplements.
4. Product Listings
Amazon mandates accurate and detailed product listings:
High-quality product images.
Compliance with specific content guidelines for medical, cosmetic, or dietary supplement products.
Verified claims supported by scientific data.
5. Logistics and Fulfillment
Amazon requires sellers to comply with:
Local storage regulations under the VAT OSS scheme.
Safe transportation and packaging for regulated products.
How AF Pharma Supports Sellers on Amazon EU
Expanding into the EU market via Amazon can be overwhelming, but AF Pharma offers tailored services to ease the process. Here’s how we can assist:
Regulatory Expertise
With years of experience in regulatory compliance across the EU, UK, US, and Australia, AF Pharma ensures your products meet Amazon’s and the EU’s stringent requirements. Whether it’s CE marking for medical devices, safety assessments for cosmetics, or proper documentation for dietary supplements, we’ve got you covered.
Product Labeling and Packaging
Our team specializes in developing compliant labels and packaging that adhere to EU standards. From including the required CE mark to ensuring accurate translations, we handle it all.
Authorized Representation
As an EU-based company, AF Pharma can act as your European Authorized Representative for medical devices or your Responsible Person for cosmetics. This fulfills one of Amazon’s core requirements and establishes your compliance with EU law.
Leverage AF Pharma for Seamless Amazon EU Sales
Selling on Amazon in the EU is a significant opportunity to grow your business, but compliance challenges can slow you down. With AF Pharma's extensive expertise in regulated industries, you can confidently meet Amazon’s requirements and expand your reach in the European market.
From regulatory advice to product labeling and authorized representation, AF Pharma is your trusted partner for navigating EU regulations and achieving Amazon success.
For more information about how AF Pharma can help, visit our website at AF Pharma Services. Let’s turn your EU expansion dreams into a reality!
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