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When people refer to "FDA law" in Greece they are usually referring to laws and regulations that govern the safety, marketing, manufacturing and distribution of food, medicines, medical devices, cosmetics and related products - the areas that the US Food and Drug Administration regulates in the United States. In Greece those fields are regulated by a mix of European Union law and national Greek law and enforced by Greek authorities such as the National Organization for Medicines - EOF, the Hellenic Food Authority - EFET, and other public health bodies. Nea Smyrni is a municipality in the Athens region, so regulatory matters are handled by national agencies and relevant courts based in Athens rather than by a separate local regulator. This guide explains the practical legal landscape, common situations that call for legal help, relevant local law themes, frequently asked questions and suggested next steps for people in Nea Smyrni who need legal advice in this area.
Regulatory matters for food, drugs, medical devices and cosmetics are complex, technical and highly regulated. You may need a lawyer when you face any of the following common situations:
- Product registration and market authorization - obtaining marketing authorizations, notifying authorities for cosmetics or food supplements, and complying with EU registration systems.
- Compliance and labeling - ensuring labels, leaflets and advertising meet Greek language, content and health-claim rules.
- Inspections and enforcement - responding to inspections, administrative fines, seizure of products or suspension of manufacturing or distribution.
- Recalls and safety incidents - managing product recalls, coordinating notifications to authorities and minimizing liability exposure.
- Clinical trials and research - getting approvals from EOF and ethics committees, drafting contracts and informed consent documents, and handling data protection issues.
- Manufacturing and distribution contracts - drafting and negotiating contracts, quality agreements, supply-chain obligations and liability allocation.
- Import-export and customs - navigating import permits, customs classification and compliance with EU rules when importing into or exporting from Greece.
- Advertising and promotion - defending against regulatory challenges or consumer complaints about misleading claims or unlawful promotion.
- Litigation and administrative appeals - appealing administrative sanctions before administrative courts in Athens or handling product liability claims in civil or criminal courts.
- Cross-border and EU law issues - managing interactions with EU bodies such as the European Medicines Agency and complying with directly applicable EU regulations.
Key legal themes and rules that apply in Nea Smyrni are driven by EU law and implemented through Greek statutes, ministerial decisions and administrative practice. Important aspects include:
- EU primacy and direct effect - Many rules on medicines, medical devices and food safety come from EU regulations and directives that apply across member states. Some EU rules are directly applicable; others require national implementation.
- National licensing and oversight - The National Organization for Medicines - EOF - oversees medicines, medical devices and clinical trials. EFET enforces food law and hygiene rules. The Ministry of Health issues implementing acts and guidance.
- Language and labeling requirements - Consumer-facing information and labeling often must be in Greek. Health claims are tightly regulated and must be authorized per EU law.
- Good manufacturing practice and quality systems - Pharmaceutical and certain medical device manufacturers must comply with Good Manufacturing Practice - GMP - standards inspected by EOF and EU inspectors.
- Clinical trial approvals - Clinical studies require EOF approvals and local ethics committee approval. Data protection and patient consent are essential, with oversight by the Hellenic Data Protection Authority in some cases.
- Administrative sanctions and criminal liability - Regulatory breaches can lead to administrative fines, product seizure or destruction, and in serious cases criminal prosecution. Appeals typically go to administrative courts in Athens.
- Importation and customs - Imports from outside the EU must meet EU safety, inspection and documentation requirements. Authorized economic operators and customs procedures are administered through Greek customs authorities.
- Consumer protection and advertising rules - The General Consumer Protection Code and specific sectoral rules govern advertising, unfair commercial practices and product liability.
The National Organization for Medicines - EOF - is the primary Greek regulator for medicines and medical devices. EOF is responsible for market authorizations, inspections, clinical trial oversight and enforcement of pharmaceutical law in Greece.
The Hellenic Food Authority - EFET - is the main body enforcing food safety, hygiene and labeling standards. EFET conducts inspections of food businesses, assesses risks and issues sanctions for non compliance.
Yes. EU regulations and directives form the foundation of health product law in Greece. Some EU regulations are directly applicable without national legislation, while directives are transposed into Greek law by national acts.
In most cases consumer-facing labels, instructions and safety information need to be available in Greek. Specific requirements depend on the product category and applicable EU or national rules.
Do not ignore official notices. Preserve documentation, take corrective actions as required, and contact a lawyer experienced in regulatory defense to assess options for administrative remedies or appeals. Strict deadlines often apply for responses and appeals.
Timelines vary. National procedures can take several months to over a year depending on the submission quality and whether additional data is requested. Centralized EU procedures via the European Medicines Agency often have defined review periods but can also extend if questions arise.
Smaller businesses can market certain products but must comply with notification or registration obligations, labeling rules and safety standards. For cosmetics, a product information file and responsible person in the EU are required. For supplements, composition, claims and labeling must meet legal limits.
Distributors and retailers face risks from selling non compliant products, improper storage or handling, misleading advertising and failing to act on recall notices. Liability can be civil, administrative or, in severe situations, criminal depending on the breach.
Yes. Administrative decisions can be challenged through administrative remedies and by filing an appeal with the administrative courts. Time limits for filing complaints are strict, so consult a lawyer promptly.
Yes. Clinical trials require coordination with EOF and local ethics committees, a clear protocol, informed consent processes in Greek, and compliance with data protection rules. Legal advice helps ensure regulatory compliance, contract structuring and patient safety obligations are met.
Useful institutions and types of organizations to consult or research include the following:
- National Organization for Medicines - EOF - for medicines, medical devices and clinical trial matters.
- Hellenic Food Authority - EFET - for food safety, hygiene and labeling matters.
- Ministry of Health - for national policy, implementing acts and guidance.
- Hellenic Data Protection Authority - for data protection issues in clinical research and consumer data processing.
- European Medicines Agency - EMA - and European Food Safety Authority - EFSA - for EU level guidance and centralized procedures.
- Athens Bar Association and local law firms - for lawyers experienced in regulatory law, product liability and administrative litigation. Nea Smyrni residents typically consult lawyers practicing in Athens courts.
- Local hospital ethics committees and university research offices - for clinical trial practicalities and approvals.
- Trade associations and industry groups - for practical compliance guidance and sector specific best practices.
If you need legal assistance in Nea Smyrni for matters related to food, medicine, medical device or cosmetic regulation, use the following stepwise approach:
- Identify the problem clearly - gather all documents such as licenses, inspection reports, product specifications, labels, correspondence with authorities and contracts.
- Seek an initial consultation - look for a lawyer or law firm with experience in regulatory law, administrative litigation and the specific sector involved. Confirm whether they have experience with EOF, EFET or EU procedures.
- Prepare key questions - ask about likely legal risks, administrative remedies, timelines, potential sanctions and options for interim measures if immediate action is required.
- Clarify fees and engagement terms - agree a clear fee arrangement, whether fixed, hourly or retainer, and understand who will handle the matter day to day.
- Take immediate compliance steps if needed - follow legal advice on product holds, recalls or corrective labeling to reduce enforcement exposure while the legal process proceeds.
- Consider multidisciplinary support - some matters require technical experts such as pharmacists, toxicologists, quality managers or regulatory affairs consultants in addition to legal counsel.
- Keep records and meet deadlines - administrative appeals and court filings have strict time limits. Maintain an organized file and act quickly when advised.
Working with a qualified lawyer who understands Greek and EU regulatory frameworks will help protect your business, ensure compliance and respond effectively to inspections or disputes. If you are in Nea Smyrni, prioritize advisors who regularly operate in the Athens regulatory and judicial environment and who can coordinate with technical specialists as needed.
