Best Drugs & Medical Devices Lawyers in Santorini

1. About Drugs & Medical Devices Law in Santorini, Greece

Santorini follows Greece's national laws that implement and enforce European Union rules on medicines and medical devices. The regulatory framework combines EU-wide regulations with Greek administrative procedures carried out by national authorities. In practice, pharmacists, clinics, hospitals, and manufacturers in Santorini must comply with both EU directives and Greece's national regulations.

Key responsibilities include ensuring safety and efficacy of medicines, proper labeling and advertising, and post market surveillance for drugs and devices. Local enforcement is carried out by Greek health authorities, the Hellenic Police for criminal matters, and the National Organization for Medicines for medicines supervision. For individuals and businesses, understanding the overlap between EU rules and Greek implementation is essential to avoid penalties.

“Regulatory oversight of medical devices in the EU rests primarily on Regulation (EU) 2017/745 and Regulation (EU) 2017/746, with member states implementing these rules through national authorities.” - EUR-Lex

“The Hellenic National Organization for Medicines (EOF) is the national regulator for medicines and oversees pharmacovigilance, licensing, and market surveillance in Greece.” - EOF official site

2. Why You May Need a Lawyer

Disputes or compliance issues in Santorini involving drugs or medical devices can trigger investigations, fines, or courtroom actions. A lawyer helps navigate complex rules, reduce penalties, and protect your rights.

• A local pharmacy importer in Santorini receives a deficiency notice from EOF alleging improper labeling of a medicine imported for the tourist season and seeks corrective action and potential fines.
• A small Santorini hospital is audited for post market surveillance compliance after a device-related adverse event, requiring a legal plan to manage documentation and regulatory responses.
• A Greek startup in Santorini develops a medical device and must secure CE marking and national approval, including conformity assessment and technical documentation requirements.
• A physician in Santorini faces a regulatory investigation for suspected off-label use of a prescription drug, with potential sanctions and licensing implications.
• A pharmacy in Santorini is challenged by a dispute over theft, counterfeit medicines, or suspicious dispensing patterns, triggering criminal and civil investigations.
• An international tourist resident in Santorini requests access to a controlled medicine while traveling and needs guidance on legal import, possession limits, and documentation.

3. Local Laws Overview

Greece implements EU medicine and medical device rules through national governance, with the most relevant EU-wide regulations listed below. Local practice in Santorini follows these rules via Greek authorities and courts.

• Regulation (EC) No 726/2004 on medicines for human use - centralised marketing authorization and EU-wide oversight of medicines; applies across Greece, including Santorini. Effective since 2004, with ongoing amendments to align with EU practice.
• Regulation (EU) 2017/745 on medical devices (MDR) - comprehensive controls on device classification, conformity assessment, surveillance, and post-market monitoring; entered into force on 26 May 2021 with transitional provisions for certain devices. Greece implemented MDR through national authorities and EOF oversight.
• Regulation (EU) 2017/746 on in vitro diagnostic devices (IVDR) - governs IVD devices, including classification, conformity assessment, and post-market surveillance; applicable in Greece with transitional timelines aligned to the EU schedule. Greece updated its regulatory framework to reflect IVDR requirements.

Recent changes emphasize stronger post-market surveillance, traceability, and stricter advertising controls for medicines and devices. In Santorini, these updates affect how distributors, clinics, and pharmacies document supply chains and report adverse events. For concrete steps, consult an attorney familiar with EU and Greek regulatory practice.

4. Frequently Asked Questions

What is Regulation (EU) 2017/745 and why does it matter in Santorini?

It defines how medical devices are placed on the market in the EU, including safety, conformity assessment, and post-market surveillance. In Santorini, this means local distributors and hospitals must follow MDR requirements and engage notified bodies when necessary. Non-compliance can lead to product recalls or penalties.

How do I check if a medicine is approved for sale in Greece?

Check the Hellenic Organization for Medicines (EOF) database for marketing authorization status and product labeling. Greek authorities require correct labeling, dosage information, and safety data sheets. Non-authorised medicines cannot be legally sold in Santorini.

What documents are needed to register a new medical device in Greece?

Prepare device technical documentation, risk management files, clinical evidence if required, and a conformity assessment report. Registration is handled by Greek authorities with input from notified bodies for MDR compliance. Expect a multi-week to multi-month process depending on device class.

Do I need a Greek lawyer to handle regulatory submissions?

While not always legally mandatory, having a local attorney with regulatory experience simplifies interactions with EOF and health authorities. A lawyer helps prepare documents, translate technical details, and protect your rights in possible enforcement actions. This reduces delays and errors in submissions.

How long does a marketing authorization process typically take in Greece?

For medicines, the centralized EU process can take several months to over a year depending on whether the application is complete and if questions arise. For medical devices, the timeline varies by class and conformity assessment, often months. Realistic planning should assume several months at minimum.

What is the difference between a device being CE marked and compliant with MDR in Santorini?

A CE mark indicates conformity with EU health and safety requirements. MDR adds renewed emphasis on ongoing surveillance and stricter technical documentation. In Santorini, distributors must verify MDR compliance for devices rather than relying on older CE marks alone.

Is advertising of medicines regulated in Santorini and how?

Yes. Advertising is regulated by EU and Greek laws, with strict rules governing promotional claims and patient-targeted materials. Violations can lead to penalties, corrective actions, and reputational harm. Always align marketing with regulated guidelines and obtain proper approvals.

What should I do if a device I sell in Santorini is recalled?

Immediately halt distribution and notify EOF and the relevant hospital or clinic partners. Prepare a root-cause analysis and documentation for post-market surveillance. Cooperate with authorities to implement recalls or field actions as required by MDR.

How can I determine if a drug importation into Santorini is lawful?

Confirm that the drug has proper marketing authorization and is imported by an authorized distributor. Maintain import records, licenses, and supplier certifications. In case of doubt, consult EOF and a regulatory attorney before proceeding.

What is the role of the Hellenic Police in drug and device enforcement in Santorini?

The Hellenic Police enforce criminal and safety-related provisions, including trafficking, counterfeiting, and unsafe devices. They collaborate with EOF and health authorities on investigations and enforcement actions. Involvement can lead to investigations, seizures, and court proceedings.

Can a medical device be used off label in Santorini?

Using a device off label may create legal risk and could violate regulatory requirements. Clinicians should follow approved indications unless authorized by appropriate regulatory pathways. Consult a regulatory attorney before considering off-label use or expanded indications.

What costs should I expect when pursuing device registration in Greece?

Costs include conformity assessment fees, notified body charges, and potential consulting fees. Additional expenses arise from translation, dossier preparation, and post-market surveillance. Budget for several thousand euros for small to mid-range devices, with higher costs for complex classifications.

Do I need to understand Greek or hire a translator for regulatory filings?

Yes. Regulatory filings often require Greek translation of technical documentation and labeling. Using a translator or bilingual regulatory counsel reduces miscommunication and speeds up processing. Accurate documentation is critical for approvals and audits.

5. Additional Resources

• - Greek regulator for medicines, cosmetics and related products; provides licensing, pharmacovigilance, and market surveillance information; official site: https://www.eof.gr
• - EU-wide regulator for medicines, with guidance on authorization procedures and safety monitoring; official site: https://www.ema.europa.eu
• - international guidance on medical device regulation and harmonization; official site: https://www.imdrf.org