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FDA Law in Greece focuses on the regulation of food, drugs, medical devices, dietary supplements, and cosmetics to ensure their safety, efficacy, and quality for consumers. While the term "FDA" specifically refers to the United States Food and Drug Administration, in Greece, similar functions are carried out by the National Organization for Medicines (EOF) and the Hellenic Food Authority (EFET). These authorities implement European Union regulations alongside national laws to oversee the production, import, marketing, labeling, and distribution of related products within Greece. Compliance with these laws is essential for both individuals and businesses operating in these sectors.
FDA Law in Greece is complex and ever changing, often requiring expert interpretation and guidance. Situations where you might need legal assistance include:
A lawyer specializing in this field can help interpret applicable regulations, prepare necessary documentation, represent you during official proceedings, and protect your interests in legal disputes.
In Greece, FDA Law is largely influenced by European Union legislation. Key components include the harmonization of Greek laws with EU regulations on food safety (Regulation EC No 178/2002), pharmaceutical products (Directive 2001/83/EC), medical devices (Regulation EU 2017/745), and cosmetics (Regulation EC No 1223/2009). The main Greek authorities are:
Businesses must comply with strict requirements regarding marketing authorizations, good manufacturing and distribution practices, proper labeling, and limitations on advertising. Periodic inspections, audits, and sampling are common features, and violations can result in significant fines, product withdrawal, or criminal prosecution.
The National Organization for Medicines (EOF) and the Hellenic Food Authority (EFET) are the main regulatory bodies overseeing pharmaceuticals, medical devices, cosmetics, and food products in Greece.
Yes, all pharmaceuticals must obtain marketing authorization from EOF, which can be through either a national or a European approval process.
Food labeling must comply with both EU and Greek regulations, including details on ingredients, allergens, nutritional value, expiration dates, and traceability.
Medical devices must be registered and certified according to both Greek law and EU Regulation EU 2017/745, which includes strict requirements for safety, efficacy, and postmarket surveillance.
Dietary supplements can be sold if they comply with EU and Greek requirements for composition, safety, and labeling. Certain supplements may require notification or registration with EOF.
Inspections typically review compliance with manufacturing, labeling, storage, safety, and documentation standards. Noncompliance can lead to fines, product recalls, or legal proceedings.
Yes, there are strict rules limiting claims, sponsorship, and the promotion of pharmaceuticals and specific food products, especially those targeting vulnerable populations like children.
Contact a legal expert immediately, comply with all recall orders, inform affected distributors and consumers, and prepare necessary documentation for regulatory authorities.
You have the right to challenge adverse decisions or fines through administrative procedures and, if necessary, the courts. Consulting a lawyer can help ensure you follow the correct process and meet all deadlines.
Yes, but imported products must comply with Greek and EU regulations. Customs checks and additional documentation may be required, especially for products from nonEU countries.
Here are some helpful organizations and resources for those seeking legal advice or information on FDA Law in Greece:
If you believe you need legal assistance in FDA Law in Greece, consider the following action steps:
Professional legal guidance can be crucial to understanding your obligations, protecting your rights, and ensuring your activities remain compliant with Greek and EU law.
