The threat the two systems were built to fight is far from abstract. The problem of counterfeit medicines first reached the international stage in 1985 at a World Health Organization conference on the rational use of medicines in Nairobi. By 2006, with falsified products flooding markets in Asia, Africa, and developing regions—Nigeria’s market was reportedly up to 75 percent counterfeit—the WHO launched the IMPACT initiative, the International Medical Products Anti-Counterfeiting Taskforce, as its principal instrument against the trade. Until that point, the European Union had largely treated counterfeiting as a problem of the developing world. That complacency ended when falsified products began appearing inside the EU’s own legitimate distribution channels, moving through the very same manufacturers, wholesalers, and pharmacies that handle genuine medicines.

The EU’s legislative response took shape in 2007, when the European Commission initiated changes that culminated in Directive 2011/62/EU and Delegated Regulation (EU) 2016/161. The Regulation became applicable across all Member States on 9 February 2019 and mandates two safety features on prescription medicine packs: a unique identifier encoded as a two-dimensional DataMatrix barcode, and an anti-tampering device such as a security seal or perforated sticker. The unique identifier carries four data elements—product code, serial number, batch number, and expiry date—encoded according to the ISO/IEC 16022 (ECC200) standard. Turkey, however, had beaten the EU to the punch by a full decade, launching ITS in 2009 as the world’s first fully functional end-to-end medicine tracking system, developed between 2008 and 2012 under the authority of the Turkish Medicines and Medical Devices Agency, TİTCK.

The architectural contrast between the two systems is the heart of the study. The European model is deliberately not a track-and-trace system. It does not record every physical movement of a package through the supply chain. Instead, it verifies authenticity at strategic control points, chiefly the pharmacy, where the pharmacist scans the barcode, confirms the identifier is authentic and active in the registry, and then decommissions the code so it cannot be reused. The data infrastructure is a stratified network of national repositories connected through a central European Medicines Verification System hub, and—crucially—it is built and managed by stakeholders, the manufacturers and marketing authorization holders themselves, under the supervision of national competent authorities. Wholesalers in the EU perform only risk-based checks, scanning returned goods or products not received directly from the manufacturer.

Turkey’s ITS is the mirror opposite: a fully centralized, state-controlled framework in which every supply chain participant—manufacturer, importer, wholesaler, pharmacy, and hospital—scans and reports every action to a single TİTCK-managed database in real time. Every change of ownership and product status is recorded, giving the regulator a live picture of where every package sits at any moment. The system covers all packaging levels, from blister packs and bottles to cartons and pallets, and applies to all medicines on the market, not just prescription products. In the EU, serialization is largely confined to prescription medicines, with over-the-counter products exempt unless listed as high-risk for falsification under the Regulation’s annexes.

One of the study’s most striking findings concerns money. Turkey has wired ITS directly into the reimbursement machinery of the Social Security Institution, SGK: only medicines whose authenticity has been verified in real time through the system are reimbursed from public funds. This closes the loop against counterfeit products and simultaneously blocks financial fraud, duplicate payments, and misuse of public money. Bulgaria has recently moved partway down this path. Since 2024, successful decommissioning of a package’s unique code in the National Verification System has been a legal precondition for reimbursement by the National Health Insurance Fund. When a pharmacist dispenses an e-prescribed medicine, the decommissioned code data flow into the National Health Information System, and the fund automatically rejects payment for any package lacking a confirmed decommissioned code—pharmacy software blocks the transaction outright if the code is missing or already used.

The two systems also diverge sharply in how they treat the patient. Turkey has built a patient-centered verification layer through official mobile applications, İTS Mobil and ÜTS Mobil, developed by the Ministry of Health and TİTCK. By scanning the DataMatrix code on a purchased medicine, citizens can instantly confirm product authenticity and registration, check whether the package belongs to a batch under recall, and read the expiry date. The application even locates the nearest on-duty pharmacies, adding a public-health service beyond anti-counterfeiting. In the EU, by contrast, verification is almost entirely a professional affair: there is no unified patient-facing application, and access varies widely by country. In Spain there is no full consumer access, and in France verification is limited to the pharmacy level. The EU patient’s role remains largely passive, resting on the pharmacist’s scan and a visual check of the tamper-evident feature.

The study also highlights an emerging functional gap. At the start of 2026, TİTCK is expanding ITS functions as part of a broader strategic plan against medicine shortages, using the system’s real-time inventory and movement data to detect supply disruptions early and intervene with regulatory measures, alongside new electronic surveillance tools for market monitoring. The European Medicines Verification System, by comparison, was designed to verify authenticity at the package level and is not effective at tracking inventories or managing shortages—even though European regulation states the system can and should serve pharmacoepidemiology and reimbursement purposes, no clear implementation mechanisms for those functions have been identified. In Turkey, the same infrastructure that fights falsification doubles as a shortage-management and supply-chain-control instrument.

Both systems share a common technological backbone: 2D DataMatrix encoding of the Global Trade Item Number, serial number, batch, and expiry date. But the authors conclude that the management models produce fundamentally different levels of control, operational depth, and social integration. Turkey’s state-run, fully end-to-end track-and-trace model offers uniform standards, direct oversight of the entire market, and complete visibility from factory to patient, which the researchers describe as the gold standard and the only true end-to-end system in the world. The European model, with its stakeholder-run, decentralized architecture and dispensing-point focus, achieves its core anti-counterfeiting goal but leaves the middle of the supply chain less strictly observed and its broader public-health functions unrealized.

The lesson for policymakers, the study suggests, is that traceability architecture is not merely a compliance exercise—it shapes what a health system can do with its data. Turkish authorities even envision ITS evolving into a clinical safety platform that verifies whether a medicine matches a patient’s personal prescription and warns of side effects or drug interactions in real time, transforming an anti-counterfeiting tool into a personalized healthcare instrument. Whether the EU’s industry-governed model can be upgraded to match that ambition, or whether Member States will need to reconsider the balance between public oversight and stakeholder management, remains an open question the comparison now puts squarely on the European agenda.

Subject of Research: Comparative analysis of pharmaceutical serialization and verification systems in Turkey and the European Union

Article Title: Comparative analysis of serialization and verification systems between Turkey and Bulgaria – scientific, regulatory, and practical aspects

Article References: Ilyaz, D., Altinel, E., Yordanov, E., Stoyanova, S., Angelov, K., Hristov, E., Harkov, S., & Petkova, V. (2026). Comparative analysis of serialization and verification systems between Turkey and Bulgaria – scientific, regulatory, and practical aspects. Pharmacia, 73, Article e215594. https://doi.org/10.3897/pharmacia.73.e215594

Image Credits: AI Generated

DOI: 10.3897/pharmacia.73.e215594

Keywords: medicine tracking, serialization, counterfeit medicines, ITS Turkey, Falsified Medicines Directive, pharmaceutical supply chain, DataMatrix barcode, TİTCK, EMVS, drug verification, Bulgaria, public health