Pharma

Our firm has extensive expertise in the pharmaceutical and life sciences sector, advising clients on regulatory compliance, intellectual property (IP) rights, and market access in Greece. We specialize in navigating Greek Law 4523/2018 on clinical trials, the EU Clinical Trials Regulation (EU) No 536/2014, and GDPR requirements for health data processing.

We assist pharmaceutical companies, medical device manufacturers, and biotech firms in securing regulatory approvals from the National Organization for Medicines (EOF) and ensuring compliance with EU directives such as the Medical Device Regulation (EU) 2017/745. Our experience also includes supporting clients with pricing and reimbursement negotiations, drafting distribution agreements, and advising on M&A transactions within the life sciences sector.

We provide comprehensive legal services across the pharma and life sciences value chain, including assistance with clinical trial agreements, licensing, and compliance with advertising and promotional restrictions under Greek Law 2251/1994. Our team advises on data protection for health-related data under GDPR and Greek Law 4624/2019, ensuring that clients meet strict regulatory standards for sensitive data processing.

We assist with market access strategies, including compliance with Greek pricing and reimbursement frameworks, as well as negotiating agreements with the National Health Insurance Organization (EOPYY). Our expertise extends to IP protection for patents, trademarks, and trade secrets, ensuring that pharmaceutical innovations are adequately safeguarded. We also support clients in disputes involving IP infringement, product liability claims, and regulatory non-compliance.

Greece’s pharma and life sciences sector is a vital contributor to the national economy, supported by strong government initiatives and EU funding. The country’s regulatory framework emphasizes compliance with EU directives on clinical trials, medical devices, and pharmaceutical products, creating a robust legal environment for innovation.

Significant investments are being directed toward R&D in biosimilars, biologics, and personalized medicine, while the government’s National Recovery and Resilience Plan prioritizes digital health and e-prescription systems. Companies must navigate challenges such as meeting strict timelines for regulatory approvals, addressing pricing pressures, and ensuring compliance with transparency obligations under EU and Greek laws.

Significant opportunities exist in the development and commercialization of biosimilars, digital health solutions, and advanced therapy medicinal products (ATMPs). Greece’s robust R&D ecosystem, supported by incentives under the Investment Incentives Law 4399/2016, encourages collaboration between academic institutions and pharmaceutical companies.

The expansion of e-health services, driven by the government’s digital transformation agenda, creates opportunities for tech-driven solutions in healthcare. Additionally, investments in the manufacturing of generic drugs and the adoption of AI in clinical trials offer lucrative prospects. Greece’s strategic location as a gateway to Europe and the Middle East further enhances its appeal for life sciences companies looking to expand their market presence.