Greece: Serialized Medicines Mandatory by February 2025

Starting February 9, 2025, Greece has fully implemented the European Falsified Medicines Directive (FMD) 2011/62/EU. This directive, mandatory in most EU countries since 2019, is a critical measure to ensure the safety and authenticity of medicines across Europe. It requires every medicine package to have a unique serialized DataMatrix code and tamper-evident packaging, making medicines traceable from production to patient.

Counterfeit Medicines: A Major Threat

Counterfeit medicines jeopardize public health and economies alike. These fake products can contain harmful substances, incorrect dosages, or ineffective ingredients, putting lives at risk. By enforcing serialization and traceability, the FMD seeks to protect patients from unsafe treatments while ensuring the integrity of the pharmaceutical supply chain.

Implementation in Greece

Greece, along with Italy, was granted an extension to adopt the directive due to existing national systems. With the February 2025 deadline, Greek pharmaceutical stakeholders must gear up for full compliance. This includes integrating advanced technologies to apply unique identification codes and tamper-evident seals on all medicines, ensuring traceability throughout the supply chain.

To support the rollout, the Hellenic Medicines Verification Organization (HMVO) launched its official website, www.hmvo.gr, providing registration resources for stakeholders:

• End Users: Wholesalers can register directly, while pharmacies will connect later through IDIKA’s system.
• Marketing Authorization Holders (MAHs): They must register and meet financial obligations with HMVO.

Additionally, HMVO has appointed Ioanna Kontomanolopoulou as its Director General to oversee the directive's implementation. 

Serialization Architecture: The Five Levels

Pharmaceutical companies must adopt a multi-level serialization framework to comply with the directive:

1. Level 1: Packaging line devices (e.g., printers and scanners) apply and verify serial codes.
2. Level 2: Line control systems manage device operations and data capture.
3. Level 3: Production management integrates serialization data with manufacturing processes.
4. Level 4: Data management consolidates serialization information and interfaces with enterprise systems.
5. Level 5: Communication systems transmit data to regulatory authorities for traceability.

This structured approach ensures compliance, enhances supply chain transparency, and supports patient safety.

Benefits and Opportunities

Serialization safeguards medicine authenticity, improves supply chain management, and boosts trust in healthcare systems. While initial implementation is costly, companies soon benefit from enhanced efficiency, market reliability, and valuable operational insights. To ensure success, partnering with experts who understand serialization complexities and can tailor solutions to specific needs is critical.

How SEA Vision can help

The adoption of the FMD in Greece is a pivotal step in combating counterfeit medicines and enhancing patient safety. By embracing serialization and traceability, Greece strengthens its pharmaceutical market's integrity and aligns with European standards.

For pharmaceutical companies navigating this transition, solutions like SEA Vision's track and trace systems offer proven expertise in serialization technologies, supporting compliance and operational excellence in the evolving regulatory landscape.