Best Drugs & Medical Devices Lawyers in Elliniko

About Drugs & Medical Devices Law in Elliniko, Greece

This guide explains the legal landscape that applies to drugs and medical devices for people in Elliniko - a municipality in the Athens metropolitan area - and for anyone interacting with Greek regulatory, clinical or commercial systems. Regulation of medicines and medical devices in Greece follows a mix of national law and European Union rules. National authorities implement and enforce EU law where applicable and also apply Greek statutes and administrative decisions on licensing, safety monitoring, manufacturing, distribution, clinical trials and professional practice.

Key themes you will encounter are regulatory approvals for marketing and clinical investigation, safety reporting and recalls, professional and pharmacy regulation, product liability for defective products, criminal rules for controlled substances, and administrative remedies for decisions by public authorities. Local courts in Athens handle civil and criminal disputes and the Administrative Court of First Instance in Athens hears challenges to regulatory decisions. If you live in Elliniko and face an issue connected to drugs or medical devices you will commonly deal with national regulators, hospital ethics committees, health-care providers and Greek courts.

Why You May Need a Lawyer

Legal issues connected to drugs and medical devices are often technical, time-sensitive and procedurally strict. A lawyer with experience in regulatory, administrative, product-liability or criminal law can help in many situations, including:

- Challenging a licensing, inspection or enforcement decision issued by the national medicines authority or the Ministry of Health.

- Responding to pharmacovigilance or vigilance actions - for example, handling adverse-event investigations, field safety corrective actions or recalls.

- Bringing or defending claims for injury caused by a defective medicine or medical device - including civil compensation claims, expert evidence and settlement negotiations.

- Advising manufacturers, distributors and importers on compliance with EU Medical Device Regulation and national requirements for placing products on the market.

- Assisting sponsors and investigators with clinical trial approvals, ethics committee processes and participant-safety obligations.

- Defending criminal investigations or prosecutions involving unlawful possession, distribution or trafficking of controlled substances.

- Advising pharmacies, health professionals and companies on licensing, advertising rules, prescription requirements, and disciplinary matters.

- Drafting and negotiating commercial agreements - supply, distribution, agency, manufacturing and clinical trial contracts - with attention to regulatory risk allocation.

Local Laws Overview

The legal framework relevant in Elliniko is primarily national Greek law working alongside EU regulation. Important features that commonly affect individuals and organisations include:

- National regulator and enforcement - The national medicines and medical devices authority administers approvals, inspections and post-market surveillance. It applies EU rules and national implementing measures when authorising medicines or overseeing medical devices.

- EU Medical Device Regulation and IVDR - Medical devices and in-vitro diagnostics are regulated under EU Regulation 2017/745 and Regulation 2017/746 respectively. These set conformity assessment, clinical evidence, post-market surveillance and labelling obligations that manufacturers and authorised representatives must meet.

- Medicines regulation and pharmacovigilance - Marketing authorisations for medicinal products must comply with EU and Greek requirements. Holders of approvals have ongoing pharmacovigilance duties - including reporting adverse reactions to the national authority.

- Clinical trials - Clinical studies require prior approval from the competent authority and local ethics committees. Trials must follow Good Clinical Practice and relevant national procedures for informed consent and participant protection.

- Product liability and civil claims - Civil law governs claims for personal injury and property damage caused by defective products. Plaintiffs commonly rely on contract, tort and product liability principles to claim compensation.

- Controlled substances and criminal law - Possession, distribution and trafficking of certain substances are regulated under national narcotics legislation and the Greek criminal code. Administrative and criminal penalties, including fines and imprisonment, may apply depending on the facts.

- Pharmacy practice and prescription rules - Retail and hospital pharmacies, prescribing practices, and professional conduct are regulated by national law and professional bodies. Some medicines are controlled and require special prescription forms or monitoring.

- Advertising and promotion - Promotion of medicines and certain device claims are restricted by law. Advertising to the public, and promotion targeted at healthcare professionals, must respect statutory and regulatory limits.

- Administrative remedies and courts - Administrative decisions by regulators can be challenged through administrative procedures and in the Administrative Courts. Civil and criminal disputes are heard in the relevant courts in Athens. Time limits and formal requirements apply to regulatory appeals and court filings.

Frequently Asked Questions

How do I report an adverse reaction to a medicine or a medical device?

If you experience a suspected adverse reaction, collect all relevant details - product name, batch or lot number, date of use, treating practitioner, and medical records if available. Report the event to the treating health professional and the national medicines authority - the regulator coordinates safety monitoring and can advise on follow-up. Reporting is important even when causation is uncertain because regulators rely on reports to identify safety signals. A lawyer can help preserve evidence and advise on legal steps if harm was severe.

Can I bring a compensation claim if a medical device harmed me?

Yes - if you suffered injury or loss because of a defective device you may have civil remedies. Claims can be brought against manufacturers, importers, distributors, hospitals or health professionals depending on the circumstances. Successful claims generally require evidence showing the device was defective, that the defect caused the harm and that the claimant suffered damages. Cases often involve technical expert reports, medical records and regulatory documentation. Time limits and procedural rules apply, so seek legal advice promptly.

What should I do if the regulator revokes or suspends a license for a drug or device I use or sell?

First, obtain the formal decision and any enforcement notices. Administrative decisions often include grounds and information about appeal rights and deadlines. You can challenge the decision through the administrative procedure and, if necessary, in the Administrative Court. A specialised lawyer can advise on interim measures - for example requesting a temporary suspension of the revocation - and prepare the administrative or judicial appeal, including technical submissions addressing regulatory compliance.

Are there special rules for importing medicines or devices into Greece?

Yes. Importation typically requires that the products comply with EU and Greek regulatory requirements, including valid marketing authorisation or legal basis for special import. Non-EU manufacturers usually need an authorised representative established in the EU. Importers must also comply with customs, labelling and pharmacovigilance obligations and ensure proper storage and distribution practices. Failure to comply can trigger administrative sanctions and seizure of goods.

What happens if the police seize medication from me?

If police seize medication - particularly controlled substances - there may be criminal and administrative consequences. Ask for a written record of the seizure and the legal basis. Do not destroy evidence. You should contact a lawyer immediately - especially if the matter involves prescription-only or controlled substances - to ensure your rights are protected and to arrange any required documentation to demonstrate lawful possession, such as prescriptions or medical records.

How are clinical trials regulated in Greece and what protections exist for participants?

Clinical trials require prior approval from the competent national authority and local ethics committees. Trials must follow Good Clinical Practice and applicable laws on informed consent and data protection. Participants have rights to information, to withdraw consent, and to be informed about risks. If you believe your rights as a participant were breached or you suffered harm, a lawyer can help evaluate potential claims against the sponsor or investigators and advise on reporting to the regulator and ethics committee.

Can I buy prescription medicines online and have them shipped to Elliniko?

Buying prescription medicines online is possible only from authorised pharmacies and sellers that meet legal requirements. Many medicines cannot be supplied without a valid prescription and some controlled medicines are prohibited from online sale. When ordering medicines online verify the seller is authorised and ensure you retain prescriptions and transaction records. If in doubt about legality or safety, consult a health professional or a lawyer.

Who enforces advertising rules for medicines and devices?

National authorities and professional bodies enforce advertising and promotion rules. Advertising that makes unapproved therapeutic claims or that targets the public with prescription-only medicines is typically prohibited. Enforcement can include fines, corrective orders, product withdrawal and professional disciplinary measures. Companies and healthcare professionals should review promotional materials with legal and regulatory counsel before distribution.

What are the typical timelines and costs for challenging a regulator's decision?

Timelines and costs vary depending on the nature of the decision and the forum - administrative appeal processes and judicial review in the Administrative Court can take months to years. There are court fees, lawyer fees and costs for technical experts. A specialised lawyer can provide an initial assessment, estimate likely timelines and costs, and discuss funding options, including staged fee arrangements or contingency-fee structures where appropriate and allowed.

Do I need a Greek-speaking lawyer for matters in Elliniko?

Proceedings before Greek administrative or civil courts and most dealings with national regulators are conducted in Greek. For practical and procedural reasons it is strongly advisable to engage a lawyer who is fluent in Greek and experienced with the national regulatory system. If you are not a Greek speaker, an experienced bilingual lawyer can help bridge the language gap and coordinate any necessary translations of documents and witness statements.

Additional Resources

Below are types of organisations and public bodies that can be helpful when dealing with drugs and medical devices issues in Elliniko:

- The national medicines and medical devices authority - the competent body for marketing authorisations, inspections, safety reporting and enforcement.

- The Ministry of Health - sets national health policy, coordinates public health actions and implements certain regulatory measures.

- Local hospital ethics committees - review and approve clinical trials and can receive complaints about trial conduct.

- National reimbursement and health insurance bodies - authorities that decide on pricing and reimbursement for medicines and devices used in the public system.

- Professional and trade associations - pharmacy associations, medical device industry groups and medical professional bodies provide guidance, standards and practitioner support.

- Patient support organisations and advocacy groups - these organisations often provide practical help and guidance to people affected by adverse events or needing information about clinical trials and compensation.

- Consumer protection authorities - handle complaints about unfair commercial practices, counterfeit or unsafe products.

- Courts and administrative tribunals in Athens - where civil, criminal and administrative disputes are litigated.

Next Steps

If you believe you need legal assistance concerning drugs or medical devices in Elliniko, consider the following practical steps:

- Preserve evidence - keep the product, packaging, batch numbers, prescriptions, medical records, photographs and any correspondence. Do not alter or destroy potential evidence.

- Obtain the formal documents - request and keep copies of any administrative decisions, inspection reports, police reports or hospital records related to the issue.

- Report safety concerns - notify your treating clinician and the national regulator about adverse events or device failures. Make a note of the report date and any reference numbers.

- Contact a specialised lawyer - look for counsel experienced in regulatory, product liability, administrative or criminal law depending on your situation. Ask about experience with health regulators and cases in Athens courts.

- Prepare for a consultation - gather documents, write a clear timeline of events and prepare questions about remedies, timing and costs. Ask the lawyer about likely strategies and interim measures to protect your interests.

- Consider expert assistance - many cases require technical or medical expert reports. Your lawyer can help identify appropriate experts and arrange opinions that support your position.

- Check deadlines - administrative and court processes have strict time limits. Early legal contact helps ensure you do not miss critical windows for appeals or preservation orders.

- Understand fees and funding - discuss fee arrangements, likely costs for experts and court fees, and whether alternative fee arrangements are available.

If you need help finding the right specialist lawyer, look for attorneys or firms with demonstrable experience in medicines and medical devices regulation, product liability and administrative litigation in Greece. An early, well-documented approach maximises your options for remedy and protection under Greek law.