Tracking Progress: Implementation of the Falsified Medicines Directive

Paul Johnston, Regulatory Executive at G&L Scientific, examines the implementation of the EU Falsified Medicines Directive (EU-FMD) and highlights recent developments in Italy and Greece.

Falsified medicines are defined as “medicines which are falsified in relation to their identity, history or source’ (EC, 2011).

The use of such products presents significant risk, as they may contain incorrect or harmful ingredients, use counterfeit packaging, or bypass formal quality, safety and efficacy evaluations. Medicinal products most vulnerable to falsification include high-cost therapies such as anti-cancer injections, as well as so-called “lifestyle medicines”, including anabolic steroids and weight-loss products (EC, 2024).

In 2024, the World Health Organization (WHO) issued a global alert following an increase in reports of falsified Ozempic products. Since 2022, counterfeit batches have been seized across multiple countries, including the UK, the USA and Brazil (WHO, 2024).

During Europol’s Operation Shield II in 2021, over 25 million units of counterfeit medicines and doping substances, valued at approximately €63 million, were seized (Europol,2021). These cases highlight the continuing need for robust, harmonized controls to prevent falsified medicines from entering the legal supply chain.

Background

In 2011, the European Commission adopted Directive 2011/62/EU, commonly referred to as the EU Falsified Medicines Directive (EU-FMD).

The directive introduced harmonized measures across the European Union to combat falsified medicines and strengthen patient safety. It amended Directive 2001/83/EC and was subsequently supplemented by Delegated Regulation (EU) 2016/161, which specifies the mandatory safety features for medicinal products and the requirements for verifying their authenticity within the EU (EC, 2016)).

The legislation required all EU Member States to implement the necessary systems and practices by February 2019 to ensure compliance with the directive.

Mandatory safety features

Two safety features are mandated for all prescription medicines and for certain non-prescription medicines deemed at risk of falsification:

1. Unique Identifier (UI)

• A 2D Data Matrix barcode containing:

• Product code (name, pharmaceutical form, strength, pack size and pack type)

• Serial number (up to 20 alphanumeric characters)

• National reimbursement or other national product number

• Batch number

• Expiry date (YYMMDD)

2. Anti-tampering device

A device that allows verification of whether the outer packaging has been tampered with. While no specific technical design is mandated, manufacturers may refer to EN ISO 21976:2020 “Packaging - Tamper verification features for medicinal product packaging” as guidance.

Method of medicines verification

Verification is conducted at national level through the mandatory upload of Unique Identifier data by manufacturers to National Medicines Verification Systems (NMVS). These national systems are connected to the EU Hub, forming a two-tier structure collectively known as the European Medicines Verification System (EMVS).

The Unique Identifier is scanned at multiple points within the supply chain to verify authenticity. At the point of dispensing, pharmacies and hospitals scan each pack and decommission it from the repository prior to supply to the patient. In some Member States, reimbursement processes are carried out simultaneously through the same system.

Recent updates

All EU Member States were required to implement mandatory safety features and verification systems connected to the EU Hub by February 2019. Italy and Greece were granted six-year exemptions due to the existence of established national systems for medicine verification and traceability. Both countries have recently issued updates regarding their transition to full EU-FMD compliance.

Italy

Italy’s previous Bollino identification system, operated by the Italian Medicines Agency (AIFA) since 2002, was deemed sufficient to justify a transitional exemption until 9 February 2025.

On 9 February 2025, the Italian Council of Ministers introduced a two-year stabilization period during which both the Bollino system and EU-FMD verification processes may operate concurrently. Full EU-FMD-compliant serialization will become mandatory from 8 February 2027, at which point the Bollino system will be discontinued (Istituto Poligrafico e Zecca dello Stato 2025).

During this transition, AIFA, the Ministry of Health and supply-chain stakeholders will implement:

• The mandatory Unique Identifier and anti-tampering device

• EU-compliant verification and decommissioning processes at appropriate points in the supply chain

• A centralized NMVS database for verification activities

A Legislative Decree effective from 8 February 2025 will provide detailed guidance, including:

• Progressive measures to introduce safety features within 30 days

• Provisions to support manufacturer compliance and adaptation timelines

• Updates to national legislation covering surveillance, market oversight and pharmacovigilance

• Introduction of a revised sanctions framework for non-compliance

Greece

On 7 February 2025, Greece issued a ministerial decision amending existing legislation to comply with the EU-FMD and Regulation (EU) 2016/161, strengthening safety measures for prescription medicines and medicines at risk of falsification (Government Gazette Of The Hellenic Republic, 2025).

The Hellenic Medicines Verification System (HMVS) became fully operational in February 2025. It complies with EU verification processes, enabling Unique Identifier authentication and supply-chain management via a national database linked to the EU Hub as part of the EMVS.

All pharmacies and end users are now equipped with at least one scanner to verify each pack prior to distribution. Patients will increasingly see the new safety features implemented on medicine packaging. Reimbursement processing is also integrated into the HMVS and occurs simultaneously with decommissioning.

Conclusion

Prior to the implementation of the EU-FMD, neither the European Medicines Agency (EMA) nor National Competent Authorities consistently monitored cases of medicine falsification, nor did they maintain distinct records separating falsified medicines from other supply-chain incidents such as theft. The EU-FMD has introduced a harmonized, transparent system that significantly strengthens oversight across the legal supply chain.

According to the European Commission, between 2011 and 2026 there were 30 confirmed cases of falsified medicines detected in the legal supply chain, with only 11 cases confirmed between 2019 and 2024, indicating a downward trend following implementation of the directive (EC, 2024).

The recent implementation of the HMVS in Greece, alongside Italy’s forthcoming transition to full EU-FMD compliance, completes EU-wide adoption of the directive. Full harmonization of verification systems enhances patient safety by substantially reducing the risk of falsified medicines entering the legal supply chain.

References

European Commission (EC) (2011) Directive 2011/62/EU. Available at: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX%3A32011L0062 (Accessed: 08 April 2025).

European Commission (EC) (2016) Delegated regulation - 2016/161/EU. Available at: https://eur-lex.europa.eu/eli/reg_del/2016/161/oj/eng (Accessed: 09 April 2025).

European Commission (EC) (2024), Study supporting the report to the European Parliament and to the Council on trends in the falsification of medicinal products and measures provided according to Directive 2011/62/EU. Available at: https://health.ec.europa.eu/publications/study-supporting-report-trends-falsification-medicinal-products-and-measures-provided-according_en (Accessed: 08 April 2025).

Europol (2021) 544 arrests and €63 million of fake pharmaceuticals and illegal doping substances seized. Available at: https://www.europol.europa.eu/media-press/newsroom/news/544-arrests-and-%E2%82%AC63-million-of-fake-pharmaceuticals-and-illegal-doping-substances-seized#:~:text=During%20Operation%20Shield%20II%2C%20law,%2C%20antivirals%2C%20hypnotics%2C%20antihistamines%20and (Accessed: 09 April 2025).

Government Gazette Of The Hellenic Republic (2025) Ministerial Decision D3(a) 6030/2025. Available at: https://www.kodiko.gr/nomothesia/document/1114260/yp.-apofasi-d3-a--6030-2025 (Accessed: 09 April 2025).

Istituto Poligrafico e Zecca dello Stato (2025) Il portale della Legge Vigente, Normattiva. Available at: https://www.normattiva.it/uri-res/N2Ls?urn%3Anir%3Astato%3Adecreto.legislativo%3A2025%3B010 (Accessed: 09 April 2025).

World Health Organization (WHO) (2024) WHO issues warning on falsified medicines used for diabetes treatment and weight loss. Available at: https://www.who.int/news/item/...;(Accessed: 08 April 2025).