Best Drugs & Medical Devices Lawyers in Thivais

About Drugs & Medical Devices Law in Thivais, Greece

Drugs and medical devices law in Thivais, Greece governs how medicines, biological products, and medical devices are researched, authorized, manufactured, marketed, distributed, used, and monitored for safety. While day-to-day issues arise locally, the rules that apply in Thivais are set mainly at the national level by Greek authorities and at the European Union level. The Hellenic National Organization for Medicines, known as EOF, is the primary national regulator for both pharmaceuticals and medical devices. EU law provides the core framework for marketing authorization of medicines and for the conformity and CE marking of devices, with Greek measures filling in local procedures, inspections, advertising controls, pricing and reimbursement, and enforcement.

For consumers, patients, healthcare professionals, and companies in Thivais, this area of law affects activities such as buying medicines, reporting side effects, participating in clinical trials, running a pharmacy, selling or importing devices, hospital procurement, and handling recalls or product liability claims. The rules are technical, strict, and safety focused, and breaches can lead to administrative fines, product seizures or withdrawals, loss of licenses, and civil or criminal liability.

Why You May Need a Lawyer

You may need a lawyer if you have suffered harm potentially linked to a medicine, vaccine, implant, or other device and you want to assess liability, compensation options, and time limits. Legal help is also important if you receive an inspection notice, noncompliance finding, or fine from EOF or a regional health authority, or if you need to manage a field safety corrective action or recall.

Companies and healthcare providers often seek counsel when launching a new product, classifying a product as a medicine versus a device, preparing clinical trial agreements, negotiating with hospitals on public procurement, managing distributor or pharmacy contracts, handling advertising or promotion reviews, or responding to allegations of off-label promotion. Pharmacists, physicians, and device manufacturers may need advice on controlled substances handling, medical cannabis licensing, or e-commerce pharmacy compliance. Individuals may need guidance on importing medicines for personal use, buying from online pharmacies, or reporting suspected counterfeit products. Data protection issues also arise for health apps, telemedicine solutions, and clinical studies.

Local Laws Overview

Regulatory framework. Medicines are governed by EU pharmaceutical law, including rules on centralized and national marketing authorizations, pharmacovigilance, manufacturing and wholesale distribution, and advertising. Devices are governed by the EU Medical Devices Regulation 2017/745 and the In Vitro Diagnostic Medical Devices Regulation 2017/746, which require CE marking, conformity assessment, unique device identification, and post-market surveillance. Greece implements and enforces these frameworks through EOF and the Ministry of Health.

Approvals and vigilance. Medicines generally require a marketing authorization before sale, except for limited named-patient or compassionate-use routes authorized by EOF. Devices must meet applicable essential requirements and bear the CE mark. EOF oversees pharmacovigilance and materiovigilance, collects adverse event reports, and can order corrective actions, suspend distribution, or mandate recalls if safety issues arise.

Advertising and promotion. Direct-to-consumer advertising of prescription medicines is prohibited. Over-the-counter medicines can be advertised subject to strict requirements. Promotion to healthcare professionals is regulated, including scientific materials, samples, and interactions. Device advertising must be accurate, supported by evidence, and not misleading. Comparative claims and off-label promotion carry enforcement risk.

Clinical trials and research. Clinical trials with medicinal products are governed by EU rules with national processes for ethics review and EOF authorization. Device clinical investigations must comply with MDR requirements. Sponsors must ensure informed consent, safety reporting, data protection, and transparency.

Pricing and reimbursement. Medicine pricing and reimbursement are set through national procedures that include reference pricing and inclusion in positive lists. The National Organization for Health Care Services Provision, known as EOPYY, manages reimbursement. Hospitals follow Greek public procurement rules when buying medicines and devices, and suppliers must meet tender and quality requirements.

Controlled substances and cannabis. Narcotic drugs and psychotropics are strictly regulated under Greek narcotics legislation. Manufacturing, distribution, prescription, and dispensing require specific licenses and controls. Medical cannabis cultivation and products are subject to special licensing and EOF oversight.

Data protection. Health data are sensitive personal data under the General Data Protection Regulation and Greek implementing law. Clinical trials, patient support programs, pharmacovigilance, and health technology must follow strict consent, minimization, security, and breach notification rules.

Liability and enforcement. Product liability for defective products, including medicines and devices, is governed by Greek consumer protection law and general tort principles. There are administrative sanctions by EOF for regulatory breaches and potential criminal liability for serious violations such as falsified medicines. Time limits apply to civil claims, including a three-year period for product liability claims from the date the injured party became aware of the damage, the defect, and the producer, and a long-stop period that can bar claims after a set number of years.

Local application in Thivais. Although rules are national and EU based, businesses and professionals in Thivais interact with local pharmacies, healthcare providers, and regional health authorities for inspections and enforcement. Disputes may be heard in local courts depending on the matter and value of the claim.

Frequently Asked Questions

What is the difference between a medicinal product and a medical device in Greece

A medicinal product achieves its principal intended action by pharmacological, immunological, or metabolic means, such as a tablet, vaccine, or biologic. A medical device achieves its primary action by physical or mechanical means, such as a stent, implant, diagnostic instrument, or software as a medical device. Classification drives which rules apply, the approval route, and post-market duties.

Who regulates medicines and devices in Thivais

Regulation is national. The Hellenic National Organization for Medicines, EOF, is the primary authority for authorization, vigilance, inspections, and enforcement. The Ministry of Health sets policy. Regional health authorities support inspections and local enforcement. EU bodies are involved for centralized medicine approvals and device conformity assessments through notified bodies.

How can I report a side effect or a device problem

Patients and healthcare professionals can report suspected adverse drug reactions and device incidents to EOF and through healthcare providers or pharmacists. Manufacturers and marketing authorization holders must have systems to collect and report events and take corrective actions. Keep detailed records of what happened, product details, batch or lot numbers, and medical outcomes.

Can I buy medicines online in Greece

Only licensed pharmacies may operate authorized online pharmacy services, and they may sell non-prescription medicines subject to rules. Prescription medicines require a valid prescription and dispensing through licensed channels. Be cautious of unverified websites and suspected falsified products. When in doubt, consult a pharmacist or lawyer.

What should I do if I think a drug or device injured me

Seek medical care first. Preserve the product, packaging, instructions, and receipts, and note batch or serial numbers. Record dates, symptoms, and healthcare visits. Report the event to EOF or your healthcare provider. Consider consulting a lawyer promptly to evaluate product liability, negligence, or warranty claims and to protect your rights before limitation periods expire.

What are the rules on advertising and promotion

Advertising of prescription medicines to the public is prohibited. Over-the-counter medicine advertising is permitted within strict content limits. Promotion to healthcare professionals must be accurate, balanced, and compliant, with transparent interactions. Medical device advertising must not mislead and must be supported by evidence. Noncompliance can lead to fines and orders to cease the advertising.

How are clinical trials approved

Clinical trials of medicines require authorization and ethics approval under EU and Greek rules. Device clinical investigations follow MDR requirements, including risk management, informed consent, and safety reporting. Sponsors must ensure data protection, insurance coverage, and compliance with monitoring and transparency obligations.

Can I bring medicines into Greece for personal use

Travellers may usually carry a reasonable quantity of medicines for personal use, ideally in original packaging with a prescription or medical letter. Special rules apply to controlled substances, which may require permits or documentation. Check requirements in advance, and keep medicines in hand luggage.

How are medicines priced and reimbursed

Pricing is set through national procedures that include reference pricing and periodic bulletins. Reimbursement depends on inclusion in positive lists and criteria managed by EOPYY. Co-payments and substitution rules may apply at the pharmacy. Companies should anticipate health technology assessment and negotiation steps for reimbursement.

What are the time limits for bringing a claim

Time limits vary by claim type. Product liability claims generally must be filed within three years from when you became aware of the damage, the defect, and the producer, with a long-stop period after which claims can be barred. Other tort or contract claims may have different limitation periods. A lawyer can assess the applicable deadlines based on your facts.

Additional Resources

Hellenic National Organization for Medicines, EOF. The national regulator for medicines and medical devices, handling authorizations, vigilance, inspections, recalls, and advertising oversight.

Ministry of Health. Sets national health policy, issues implementing measures, and coordinates with regional health authorities.

National Organization for Health Care Services Provision, EOPYY. Manages reimbursement, positive lists, and relations with healthcare providers.

Greek National Ethics Committee for clinical trials. Reviews clinical research protocols for ethical compliance and patient protection.

Hellenic Data Protection Authority. Oversees compliance with data protection rules for health data, clinical trials, and digital health services.

Panhellenic Pharmaceutical Association. Professional body for pharmacists, with guidance on pharmacy practice and compliance.

Regional health authorities for Central Greece. Support local inspections and enforcement affecting pharmacies, clinics, and distributors in the wider area that includes Thivais.

Next Steps

Document your situation carefully. Keep all product packaging, instructions, serial or batch numbers, prescriptions, invoices, and correspondence. Record a clear timeline of events, symptoms, medical visits, and costs.

Seek medical advice and report safety issues. Ensure your healthcare provider records suspected adverse reactions or device incidents and consider submitting a report to EOF. Do not continue using a suspect product without professional guidance.

Consult a qualified lawyer. Choose someone with experience in medicines and devices, product liability, and regulatory compliance. Ask about experience with EOF proceedings, recalls, clinical trials, and hospital procurement if relevant to your case.

Preserve evidence and confidentiality. Avoid public posts that could compromise your case. For companies, initiate internal investigations under legal privilege, secure quality and vigilance records, and consider a corrective action plan if needed.

Check deadlines. Identify applicable limitation periods for civil claims and any strict timelines for regulatory responses. A lawyer can help you act within the required time frames.

Plan your resolution strategy. Options may include regulatory engagement with EOF, negotiation with manufacturers or insurers, mediation, or litigation in the appropriate court. For businesses, align legal strategy with quality, safety, and market access plans.

Important. This guide is for general information and is not legal advice. For advice tailored to your circumstances in Thivais, Greece, speak with a qualified lawyer.