Best Drugs & Medical Devices Lawyers in Vouliagmeni

About Drugs & Medical Devices Law in Vouliagmeni, Greece

Drugs and medical devices in Vouliagmeni are governed by Greek law and European Union rules, since Greece is an EU member. The National Organization for Medicines, commonly known by its Greek acronym EOF, is the primary regulator for medicines, medical devices, cosmetics, and related health products. EU regulations set the technical and safety framework, most notably the EU Medical Device Regulation 2017/745 and the In Vitro Diagnostic Regulation 2017/746, while medicines are regulated under the EU system that covers marketing authorizations, pharmacovigilance, and manufacturing standards. Local practice in Vouliagmeni aligns with national procedures centered in Attica, where many regulatory bodies, courts, and healthcare institutions operate. Businesses and individuals must comply with strict rules on authorization, safety monitoring, advertising, distribution, pricing and reimbursement, and data protection.

Why You May Need a Lawyer

You may need legal support if you plan to place a medical device on the Greek market, apply for a marketing authorization for a medicine, or run a clinical trial in a local hospital or clinic. Legal guidance is also important for product recalls and field safety corrective actions, distribution and wholesaling licenses, GDP and GMP compliance, pricing and reimbursement negotiations, and interactions with healthcare professionals. Patients and consumers may seek a lawyer for product liability and compensation claims, issues with counterfeit or defective products, problems with pharmacy or hospital dispensing, or privacy concerns linked to health data. Companies often engage lawyers to review promotional materials, manage inspections and audits by EOF, structure agreements with distributors and authorized representatives, and respond to enforcement actions.

Local Laws Overview

Regulatory framework: EOF supervises medicines and devices, approves clinical trials together with the National Ethics Committee, monitors safety, and enforces advertising rules. EU law applies directly for devices under MDR and IVDR, and EU procedures apply for medicines, including centralized marketing authorizations managed by the European Medicines Agency, as well as national or mutual recognition procedures managed by EOF.

Market access: Medicines require a marketing authorization and Greek language labeling and leaflets. Devices must have CE marking under MDR or IVDR with appropriate conformity assessment, a Unique Device Identification code, and Greek language labeling and instructions. Non-EU manufacturers must appoint an EU authorized representative and importers in Greece must meet MDR obligations.

Safety and vigilance: Companies must operate pharmacovigilance systems for medicines and device vigilance systems for incident reporting and field corrective actions. Adverse reactions are reported via the EOF Yellow Card program, and device incidents are reported to EOF with timelines based on seriousness.

Manufacturing and distribution: Manufacturers, importers, and wholesalers need appropriate licenses and must comply with GMP or GDP standards. Retail sale of medicines is restricted to licensed pharmacies. Online sale is limited and requires specific conditions. Only certain non-prescription medicines may be sold online by licensed Greek pharmacies that meet regulatory requirements.

Advertising and promotion: Direct-to-consumer advertising is generally prohibited for prescription-only medicines. OTC medicine advertising must be accurate, pre-cleared where required, and compliant with EOF rules. Device promotion must be consistent with the device’s intended purpose and CE marking. Transfers of value to healthcare professionals are regulated with transparency and ethics requirements, subject to data protection rules.

Pricing and reimbursement: Medicine prices are set by the Ministry of Health through pricing bulletins. Reimbursement decisions for medicines and certain devices are handled via national processes, including a positive list and negotiations with the public payer EOPYY. Companies may face statutory rebates and clawbacks tied to public spending limits.

Clinical trials and research: Clinical trials require approvals from EOF and the National Ethics Committee, insurance coverage for participants, and robust informed consent and data protection measures. The EU Clinical Trials Regulation applies, using the EU portal and database for submissions and transparency.

Data protection: Health data are special category data under the EU GDPR and Greek implementing law. Sponsors, investigators, pharmacies, and manufacturers must ensure lawful bases for processing, implement safeguards, and respect patient rights.

Product liability and consumer protection: Greek law implements EU strict product liability. A producer can be liable for a defective product that causes damage regardless of fault. Claims are subject to limitation periods that typically run three years from the date the injured party knew of the damage, the defect, and the producer, and a 10-year long stop from when the product was put into circulation. Separate rules apply for medical malpractice and contractual claims.

Frequently Asked Questions

Who regulates medicines and medical devices in Vouliagmeni and throughout Greece

The National Organization for Medicines, EOF, regulates medicines, medical devices, cosmetics, and certain health products nationwide. It oversees approvals, pharmacovigilance and device vigilance, inspections, advertising, and enforcement. Local matters in Vouliagmeni fall under the same national system, with cases typically handled through the Attica region.

What approvals do I need to market a medical device in Greece

A device must comply with the EU MDR, have CE marking through the appropriate conformity assessment route, meet UDI requirements, and carry Greek language labeling and instructions. Non-EU manufacturers need an EU authorized representative. Importers and distributors must fulfill MDR economic operator obligations, keep technical documentation available, and report incidents to EOF.

How do I obtain a marketing authorization for a medicine

You may use the centralized EU procedure for eligible products or apply through national, mutual recognition, or decentralized procedures with EOF. You will need a complete dossier covering quality, safety, and efficacy, risk management plans, and pharmacovigilance arrangements, as well as Greek labeling and patient information.

Can I advertise medicines or devices to the public

Prescription-only medicines cannot be advertised to the public. OTC medicine advertising is allowed under strict EOF rules and often requires prior clearance. Device advertising must be truthful, consistent with the device’s intended use, and must not mislead. Promotion to healthcare professionals is regulated, and interactions with them are subject to ethical and transparency requirements.

How are adverse reactions and device incidents reported

Suspected adverse reactions are reported through the EOF Yellow Card system by patients or healthcare professionals. Device incidents are reported to EOF by manufacturers, importers, or users, with expedited timelines for serious incidents. Companies must maintain vigilance systems and cooperate with investigations and corrective actions.

Can I sell medicines online in Greece

Only licensed Greek pharmacies may sell certain non-prescription medicines online, and they must meet specific regulatory conditions. Prescription medicines cannot be sold online to the public. Devices can be sold online if compliant with MDR and local consumer rules, but advertising and claims must remain accurate and lawful.

What are the rules for clinical trials in Greece

Clinical trials must be submitted through the EU portal under the EU Clinical Trials Regulation, with approvals by EOF and the National Ethics Committee. Trials require insurance, informed consent, data protection compliance, safety reporting, and transparency obligations. Contracts with sites and investigators should address responsibilities, indemnities, and data management.

What should I do if I suspect a medicine or device is counterfeit or unsafe

Do not use the product and report it to your pharmacist, healthcare provider, or EOF. Provide batch numbers, purchase details, and any adverse effects experienced. Companies must initiate recalls or field safety corrective actions when necessary and inform EOF and the supply chain promptly.

How do product liability claims work for defective medicines or devices

Under Greek law implementing EU rules, liability for defective products is strict. You typically have three years from when you became aware of the damage, the defect, and the producer to file a claim, with a 10-year long stop from when the product entered the market. Evidence such as medical records, packaging, and expert opinions is important. A lawyer can assess whether to claim under product liability, negligence, contract, or consumer protection.

Are CBD products and medical cannabis legal in Greece

Industrial hemp and certain CBD products are permitted under strict conditions, including very low THC thresholds and correct classification as food, cosmetic, or device as applicable. Claims must not be medicinal unless the product has a marketing authorization. Medicinal cannabis is subject to controlled substances rules and can only be supplied under specific authorizations. Always confirm classification and permissions with EOF before marketing.

Additional Resources

National Organization for Medicines EOF for approvals, safety reporting, advertising, and enforcement. Ministry of Health for policy, pricing bulletins, and public health rules. National Ethics Committee for ethics approvals of clinical research. EOPYY the national health insurance organization for reimbursement and contracts. Hellenic Medicines Verification Organisation for serialization and anti-counterfeit measures. Hellenic Data Protection Authority for guidance on GDPR compliance in health data. Professional bodies such as the Hellenic Medical Association and the Panhellenic Pharmaceutical Association for professional standards and practice guidance. Industry associations such as SFEE and PEF for self-regulatory codes and best practices.

Next Steps

Clarify your objective, whether it is market entry, compliance review, dispute resolution, or a claim for injury or loss. Gather key documents, such as technical files, CE certificates, clinical data, batch records, promotional materials, contracts, prescriptions, purchase receipts, medical records, and any communications with authorities. Note critical dates to protect limitation periods, for example the three-year limit for product liability claims and procedural deadlines for regulatory submissions or appeals. Seek a consultation with a lawyer experienced in medicines and devices in the Attica region, explain your case and goals, and request a scope, timeline, and cost estimate. Agree an engagement plan that may include regulatory filings, safety reporting, negotiations with EOPYY, audit or inspection readiness, contractual amendments, or litigation strategy. Implement corrective actions, train staff, and set up monitoring to maintain ongoing compliance. If urgent safety or enforcement issues arise, contact EOF promptly and follow legal advice to mitigate risk.