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Drug and medical device matters in Agia Paraskevi are governed by a mix of Greek national law, European Union regulation and administrative practice applied by national authorities. Rules cover product authorization, safety monitoring, manufacturing and distribution, advertising, pricing and reimbursement, clinical trials, professional conduct and criminal sanctions for illegal activity. For individuals and businesses in Agia Paraskevi the practical effect is that approvals, complaints and enforcement actions are handled through national bodies based in Athens while courts and administrative tribunals decide civil, criminal and administrative disputes.
Lawyers with expertise in drugs and medical devices can help in many common situations:
- If you or a family member suffered harm from a medicine or device - to assess liability and bring a claim for compensation.
- If a manufacturer, distributor or pharmacy faces regulatory enforcement, inspections, or product recall procedures.
- If you are a company seeking marketing authorization, CE marking, conformity assessment or compliance with the EU Medical Device Regulation.
- If you participate in or run a clinical trial and need help with contracts, patient consent, or regulatory approvals.
- If you face criminal investigation for alleged illegal distribution, smuggling or possession of controlled substances.
- If you need help with pricing, reimbursement disputes with the national payer, or parallel trade and import/export permissions.
- If a healthcare professional faces disciplinary proceedings for prescription or handling of medicines and devices.
Key legal aspects relevant locally include the following points:
- Market authorization and conformity - Medicines require marketing authorization granted under Greek law following EU rules. Medical devices must meet EU Medical Device Regulation requirements and obtain CE marking via a notified body.
- Pharmacovigilance and vigilance - Manufacturers and healthcare providers have mandatory reporting duties for adverse drug reactions and device incidents to the national competent authority.
- Clinical trials - Clinical research is regulated by EU clinical trial rules and by national procedures for ethics committee review and authorization.
- Advertising and promotion - Strict limits regulate promotion of prescription medicines and certain rules apply for medical device promotion to professionals and the public.
- Pricing and reimbursement - The Ministry of Health and national payers determine reimbursement rules and price controls for pharmaceuticals and some devices; decisions can be administratively challenged.
- Manufacturing and distribution standards - Good Manufacturing Practice and Good Distribution Practice are enforced by national inspectors.
- Criminal and administrative sanctions - Illegal distribution, smuggling or unauthorized manufacture may attract criminal prosecution. Administrative fines and market suspensions can be imposed by the national authority.
- Civil liability - Victims can sue under tort and product liability principles for defective products or negligent care. Greek courts apply national law and relevant EU directives.
- Data protection and consent - Processing health data requires compliance with GDPR and Greek data protection law; informed consent rules apply in clinical settings and trials.
Seek immediate medical care first. Preserve packaging, labels, prescriptions and any medical records. Report the incident to the manufacturer and to the national competent authority. Contact a lawyer experienced in product liability and clinical negligence to assess whether you have grounds for compensation and to preserve evidence and expert reports.
The principal national authority is responsible for medicines and medical devices and enforces regulatory compliance, inspections, and reporting obligations. Enforcement is coordinated with EU frameworks and may involve administrative sanctions, recalls and communication with manufacturers.
Yes. Administrative decisions by regulatory authorities can usually be challenged through administrative appeal procedures and, if necessary, in the administrative courts. A lawyer can advise on deadlines, grounds for appeal and the evidence needed.
Possible remedies include civil claims for tort or breach of product safety obligations, claims under product liability laws for defective products, and professional negligence claims if care was substandard. Compensation can cover medical costs, lost earnings and pain and suffering subject to proof.
Participants must provide informed consent. Ethics committee approval and national authorization are required before trials begin. There are rules on safety reporting, insurance and compensation for trial-related injury. A lawyer can help review consent forms and contracts and advise on remedies for breaches.
Advertising of prescription medicines to the public is prohibited. Promotion to healthcare professionals is permitted but regulated. Medical device advertising must not mislead and must comply with labeling and instruction requirements. Sanctions can apply for breaches.
Illegal distribution and trafficking of controlled substances are criminal offenses under Greek law and can result in prosecution, imprisonment and heavy fines. Administrative sanctions and professional disciplinary measures may apply to pharmacists or healthcare workers involved.
Limitation periods vary depending on the type of claim - civil tort, contract or product liability - and specific circumstances. Some periods run from the date of the harmful event, others from the date the harm was discovered. Consult a lawyer promptly to avoid losing the right to bring a claim.
Manufacturers must monitor safety, report adverse events, maintain quality systems, conduct corrective actions or recalls when necessary, and cooperate with regulators. They must also ensure post-market surveillance and keep technical documentation up to date.
Medicine manufacturers typically obtain marketing authorization through national or centralized EU procedures depending on the product. Medical device businesses must follow the conformity assessment process required by the EU Medical Device Regulation, work with a notified body where applicable, and register with national authorities before placing products on the market.
Helpful institutions and organizations for people in Agia Paraskevi include national and EU bodies and professional organizations that provide guidance, oversight and complaint channels:
- The national competent authority responsible for medicines and medical devices - for reporting adverse events and regulatory matters.
- The Ministry of Health - for policy, reimbursement and public health information.
- The national payer and reimbursement agency - for disputes about coverage and reimbursement.
- Ethics committees and clinical trial offices - for information on trial approvals and participant protections.
- Professional associations - local medical and pharmacy associations for professional conduct and disciplinary questions.
- Consumer protection bodies and ombudsman services - for consumer rights and product complaints.
- European Medicines Agency and EU medical device regulators - for overarching EU rules and guidance that affect national practice.
- Data protection authority - for questions about processing health data under GDPR.
If you need legal assistance in Agia Paraskevi for drugs or medical device issues follow these steps:
- Gather documents - keep labels, prescriptions, invoices, medical records, correspondence with manufacturers and any incident reports.
- Preserve evidence - retain the product, packaging and any devices, photos and witness contact details.
- Report promptly - notify the manufacturer and file a report with the national competent authority for adverse events or safety incidents.
- Seek medical and expert assessment - obtain medical reports and, if needed, expert technical evaluations to support any claim.
- Consult a specialized lawyer - look for attorneys or firms with experience in pharmaceuticals, medical devices, regulatory law and product liability to discuss remedies and next steps.
- Be mindful of deadlines - ask your lawyer about limitation periods and administrative appeal deadlines to protect your rights.
- Consider dispute resolution options - your lawyer can advise whether administrative appeal, mediation, settlement negotiations or court proceedings are most appropriate.
Engaging a lawyer early improves your chances of preserving evidence, meeting procedural requirements and achieving a favorable outcome. A specialist will explain the options, likely timelines and costs so you can make an informed decision.
