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 that is closely harmonized with European Union rules. The National Organization for Medicines - EOF is the competent authority for medicines, medical devices, and related products across Greece, including the municipality of Vari - Voula - Vouliagmeni in Attica. EU rules apply for marketing authorization, safety, and vigilance, while national rules manage pricing, reimbursement, inspections, advertising, and enforcement.

Medicines are authorized either centrally through the European Medicines Agency for EU - wide use or through national - mutual recognition - decentralized procedures supervised by EOF. Medical devices must bear the CE mark under the EU Medical Device Regulation - MDR and In Vitro Diagnostic Regulation - IVDR. After products reach the market, companies must comply with pharmacovigilance and materiovigilance, report adverse events, conduct recalls when needed, and cooperate with EOF inspections.

Local healthcare providers, pharmacies, clinics, and distributors in the Vouliagmeni area must follow these national - EU standards, including Greek language labeling, storage and distribution rules, advertising restrictions, and transparency in interactions with healthcare professionals. Patients benefit from safety monitoring frameworks and have avenues for compensation if harmed by defective products.

Why You May Need a Lawyer

You may need a lawyer in Vouliagmeni for several reasons related to drugs and medical devices. Companies often seek counsel to obtain marketing authorizations, register devices, set up distribution or parallel trade, comply with labeling and vigilance obligations, and respond to EOF inspections. Legal guidance is also vital for clinical trials and device investigations, drafting agreements with contract research organizations and healthcare providers, and ensuring GDPR - compliant handling of health data.

Marketing and promotion raise legal questions, including what claims are permitted, how to engage with healthcare professionals, sponsorships of scientific events, and required disclosures. Pricing and reimbursement strategy requires specialized knowledge of the positive list, health technology assessment, and negotiations with EOPYY. In disputes, lawyers handle product liability claims, recalls and corrective actions, insurance coverage, tenders and procurement challenges, and competition or parallel import issues.

Patients and healthcare providers may need counsel to evaluate injuries allegedly caused by medicines or devices, navigate adverse event reporting and medical records, and pursue or defend civil claims. Pharmacies and clinics may require advice on online sales, pharmacy practice limits, device maintenance obligations, and responses to regional health inspections in the Attica prefecture.

Local Laws Overview

Regulatory framework. Medicines are governed by EU Directive 2001 - 83 - EC and Regulation 726 - 2004, as implemented in Greece, with EOF as the national competent authority. Medical devices are governed by EU MDR 2017 - 745 and IVDR 2017 - 746, which apply directly, supported by Greek implementing measures and EOF guidance. Products must meet quality - safety - efficacy or performance requirements and be manufactured and distributed in line with Good Manufacturing Practice and Good Distribution Practice where applicable.

Authorizations and registrations. Medicines require a marketing authorization before sale, obtained via the national, mutual recognition or decentralized routes through EOF, or the EMA central route. Most medical devices are not individually authorized by EOF but must carry CE marking based on conformity assessment with a notified body for higher - risk classes, while EOF oversees market surveillance and vigilance.

Clinical trials and investigations. Interventional clinical trials with medicines are governed by EU rules and require approval by EOF and a national ethics committee. Clinical investigations for medical devices under MDR also require EOF authorization and ethics review. Local site approvals and hospital contracts are typically needed for study conduct in the Attica region.

Advertising and promotion. Advertising of prescription medicines to the public is prohibited. Over - the - counter products can be advertised to consumers under strict conditions. Promotion to healthcare professionals must be accurate, balanced, and compliant with EOF decisions and self - regulatory industry codes. Claims for devices must be supported by clinical evidence and must not mislead. Sponsorships, samples, and hospitality are restricted and subject to transparency rules.

Pricing and reimbursement. Prices of prescription medicines are set through national price bulletins, typically using international reference pricing. Reimbursement by EOPYY depends on inclusion in the positive list, health technology assessment, and negotiation outcomes. Devices used in hospitals may be procured through public tenders with technical specifications and value - based criteria. Coding and reimbursement of devices varies by category and setting.

Distribution and online sales. Wholesalers and pharmacies need EOF - issued licenses and must comply with GDP for medicinal products. The Falsified Medicines Directive requires safety features and end - user verification in pharmacies through the Hellenic Medicines Verification Organisation. Online sale of prescription medicines to the public is prohibited. Licensed pharmacies may sell certain OTC medicines online subject to Greek rules. Devices can be sold online depending on device type and consumer protection law.

Vigilance and recalls. Marketing authorization holders and manufacturers must monitor and report adverse drug reactions and serious incidents with devices to EOF within specified timelines, and perform field safety corrective actions when needed. Healthcare providers in Vouliagmeni should maintain incident logs and cooperate with reporting. Patients can report suspected adverse reactions directly to EOF or through their healthcare professional.

Early access and imports. Named - patient or compassionate use may be available under EU and Greek frameworks overseen by EOF. The Institute of Pharmaceutical Research and Technology - IFET facilitates imports of unlicensed medicines in specific cases, for example when a therapy is not marketed in Greece.

Product liability and consumer protection. Greece applies the EU Product Liability Directive through the Consumer Protection Law, imposing strict liability on producers for defective products that cause damage. General tort rules of the Greek Civil Code may also apply. Limitation periods can be short, so timely legal advice is important.

Data protection. The GDPR and Greek data protection law apply to clinical data, patient registries, pharmacovigilance records, and device logs. Health data are a special category requiring heightened safeguards and lawful bases for processing, including transparency notices and security measures.

Enforcement and inspections. EOF and the Ministry of Health perform market surveillance, advertising controls, and inspections, and can order product withdrawals, impose administrative fines, and refer matters for criminal prosecution. In the Attica region that includes Vouliagmeni, regional public health directorates may conduct facility inspections and enforce local health and safety requirements.

Language and labeling. Labels, instructions for use, patient leaflets, and advertising materials must be in the Greek language and meet format - content standards. Device UDI and registration obligations apply progressively under MDR and IVDR, with entries in EU databases as they come online.

Frequently Asked Questions

Who regulates medicines and medical devices in Vouliagmeni

The National Organization for Medicines - EOF regulates medicines and medical devices throughout Greece, including Vouliagmeni. The European Medicines Agency handles EU - wide authorizations for certain medicines. Local inspections can also involve the Attica regional health authorities.

Do I need a local entity to market a product in Greece

Medicines require a marketing authorization holder established in the EU or EEA and a local representative in Greece for pharmacovigilance and distribution coordination. Device manufacturers outside the EU must appoint an EU - based authorized representative. Local distributors in Greece must hold appropriate licenses.

How do I obtain a marketing authorization for a medicine

You can apply via the EMA central procedure for eligible products or through national, mutual recognition, or decentralized procedures coordinated with EOF. Applications require full quality, nonclinical, and clinical data, risk management plans, and proposed labeling in Greek.

What is required for medical device compliance

Devices must comply with EU MDR, be correctly classified by risk, undergo conformity assessment, and bear CE marking. Technical documentation, clinical evaluation, post - market surveillance plans, UDI assignment, and vigilance systems are required. Higher - risk devices typically need notified body assessment.

Can I advertise medicines or devices to the public in Greece

Advertising prescription medicines to the public is prohibited. OTC advertising is allowed with restrictions. Device advertising must be truthful and not misleading, with certain higher - risk professional - use devices advertised only to professionals. All promotion to healthcare professionals is regulated and must be supported by evidence.

How are prices and reimbursement decided

Prescription medicine prices are set by national bulletins using reference pricing rules. Reimbursement depends on inclusion in the positive list after health technology assessment and possible negotiation with EOPYY. Devices may be reimbursed through separate schedules or procured via public tenders for hospitals.

What should I do if a serious adverse event or device incident occurs

Seek immediate medical attention, preserve product and packaging, record batch or UDI details, and report the event. Healthcare professionals must report to EOF within required timelines. Companies must conduct investigations and, if needed, implement field safety corrective actions and inform EOF and users.

Are online sales of medicines allowed in Greece

Online sale of prescription medicines to the public is prohibited. Licensed pharmacies may sell certain OTC products online under strict rules. Devices can be sold online if compliant with consumer and product safety laws, and professional - use devices should not be marketed to consumers.

What liability exists for defective drugs or devices

Producers are strictly liable under Greek consumer protection law for damage caused by defects. Additional claims may arise under general tort law or contract. Time limits are short - typically three years from when the injured party knew of the damage, the defect, and the producer, with a ten - year long - stop from when the product entered circulation.

How do clinical trials and device investigations get approved

They require authorization by EOF and approval by a national ethics committee, plus hospital or site contracts. Applicants must provide protocols, investigator credentials, informed consent forms, safety management plans, data protection measures, and insurance coverage.

Additional Resources

National Organization for Medicines - EOF - Greece's competent authority for medicines and medical devices, responsible for authorizations, vigilance, inspections, and enforcement.

Ministry of Health - Sets health policy, issues price bulletins, and oversees national health regulations.

European Medicines Agency - Coordinates EU centralized marketing authorizations and pharmacovigilance.

Hellenic Medicines Verification Organisation - Coordinates serialization and verification under the Falsified Medicines Directive for pharmacies and wholesalers.

Institute of Pharmaceutical Research and Technology - IFET - Facilitates imports of unlicensed medicines for patient access when appropriate.

National Ethics Committee - Reviews clinical trials and device investigations for ethical compliance.

National Organization for the Provision of Health Services - EOPYY - Manages reimbursement, contracts, and the positive list for medicines.

Hellenic Data Protection Authority - Supervises compliance with GDPR and Greek data protection law, including processing of health data.

Hellenic Association of Pharmaceutical Companies - SFEE - Self - regulatory codes and guidance on interactions with healthcare professionals.

Hellenic Association of Medical Technology Companies - SEIV - Industry association for medical devices and diagnostics with compliance resources.

Next Steps

Clarify your goal. Define whether you need help with an authorization, a compliance question, an advertising review, a pricing - reimbursement strategy, a distribution agreement, a clinical study, or an injury claim.

Gather documents. Collect product information, regulatory correspondence, labeling and instructions, contracts, tender files, adverse event records, medical records, and any inspector reports. Preserve device UDI or medicine batch numbers where relevant.

Check timelines. For product liability, there is typically a three - year limitation from knowledge of damage, defect, and producer, and a ten - year long - stop. For general tort claims, limitation is often five years from knowledge, with a longer maximum period. Deadlines in tenders and pricing - reimbursement processes can be very short.

Engage qualified counsel. Choose a lawyer experienced in Greek - EU pharmaceutical and device law who understands EOF practice, Attica regional procedures, and hospital procurement. Ask for a clear scope, timeline, and budget, and request a risk - based compliance plan.

Plan compliance actions. If you are a company, confirm vigilance systems, designate Greek - speaking contacts, validate labeling in Greek, train staff on promotion rules, review GDPR measures for health data, and prepare for EOF inspections. If you are a patient or provider, ensure adverse events are reported and evidence is preserved.

Consider dispute resolution strategy. Evaluate negotiation, administrative appeals before EOF or the Ministry of Health, tender challenges, or court litigation. Review insurance coverage and notification duties early.

Stay updated. EU and Greek rules evolve, including MDR - IVDR transition timelines, HTA procedures, and transparency obligations. Monitor EOF circulars and industry codes, and schedule periodic legal reviews.

This guide provides general information only and is not legal advice. For advice on your situation in Vouliagmeni, consult a qualified Greek lawyer or regulatory specialist.