FDA Certificates and the EU - Import/Export
by
Stephanie Padly-Julien on Mar. 05, 2013
Business Government International
Summary: Depending on the product you export, you must be registered with the FDA and have a certificate. The EU now requires manufacturers/exporters to be registered as well.
If you are planning on exporting from the US to Europe, you should check whether the manufacturer of the product is certified and licensed under the FDA and under the EU. While the EU previously only required the exporter/manufacturer to be listed on the FDA list - it now also requires the manufacturer/exporter to be certified and listed in the EU list. The FDA will update the EU of it's new certifications issued quarterly; however, there can be a lag of about 30 days for the EU to recognize it and added that manufacturer/exporter to its list.
Failure to appear on the EU list places a risk on the shipment being rejected. This also means that the shipper should check the lists before accepting to ship the goods in order to minimize the risks of rejection at customs once arriving in the EU country. Please note that not all countries require the same information and certification and each country has it's individual list.
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*This information is general information that is not be considered legal advice. It does not create an attorney-client relationship or privileges. Call us directly so we can analyze your individual situation and needs.