Pharmaceuticals are a category where counterfeiting touches patient health directly. According to the World Health Organization's 2017 estimate, one in every 10 medicines in low- and middle-income countries is substandard or falsified, and around USD 30.5 billion a year is spent on such products. That is why pharmaceuticals became the field where product-level serialisation and verification along the supply chain were applied earliest and most comprehensively.
Türkiye's Pharmaceutical Track and Trace System (İTS) and the European Union's Falsified Medicines Directive (FMD) answer the same problem with two different architectures. Understanding how both models work is instructive for brands in neighbouring categories such as food supplements and cosmetics, where the regulatory framework works differently.
İTS: the model where every pack is tracked
According to the Turkish Medicines and Medical Devices Agency (TİTCK), İTS is an adaptation of track-and-trace systems used worldwide to the pharmaceutical sector. The system was rolled out nationwide by the Ministry of Health in 2010. The inbound and outbound movements of every medicine pack are notified through a data matrix code; the product's latest location, time and status are held in a real-time database.
Scope and timeline
As reported by the Pharmaceutical Manufacturers Association (İEİS), the data matrix code became mandatory for all products manufactured from 1 January 2010; products made before that date without a code were allowed to be sold until 1 July 2010. In 2012 an identification requirement was introduced for transport packaging as well. İEİS notes that İTS was applied at this scope for the first time in the world in Türkiye.
The code is a two-dimensional DataMatrix symbol carrying four core pieces of data:
- The product's barcode number (GTIN)
- The serial number
- The expiry date
- The batch number
According to TİTCK, the system covers prescription and non-prescription medicines and medical nutrition products; saline solutions, radiopharmaceuticals and magistral preparations are out of scope. Notifications are made by manufacturers, importers, pharmaceutical warehouses, pharmacies, hospitals and reimbursement institutions. The system's aims include preventing the sale of falsified and smuggled medicines, ensuring patient safety and preventing coupon fraud.
FMD: the end-to-end verification model
In the EU the framework is set by Directive 2011/62/EU, adopted on 8 June 2011, which amends Directive 2001/83/EC. As a rule the directive requires two safety features on the packaging of prescription medicines: a unique identifier and an anti-tampering device. For non-prescription medicines these features are required only where the risk of falsification is found to be high. The directive also introduces a common EU logo for legally operating online pharmacies and a registration obligation for medicine brokers.
The technical details sit in Delegated Regulation (EU) 2016/161. Under the rules, which have applied since 9 February 2019:
- The unique identifier consists of the product code, a serial number of at most 20 characters, a national reimbursement number where required, the batch number and the expiry date.
- The probability of guessing the serial number must be negligible. In other words, the numbers are generated randomly rather than sequentially.
- The code is printed as a Data Matrix compliant with ISO/IEC 16022, and the print quality must exceed a given threshold. The data also appears in readable form where the packaging allows.
- The codes are connected to national and supranational repositories through a central data routing hub.
- Pharmacies and healthcare institutions verify the code and decommission it when dispensing the product to the patient. The same code can then no longer be used a second time; under certain conditions the operation can be reversed within 10 days.
- Wholesalers are obliged to verify returned products and products coming from outside authorised sources.
The difference between the two architectures
İTS is a track-and-trace system that records every change of hands along the chain. The FMD largely focuses on the two ends of the chain: codes are uploaded to the system and verified and decommissioned at the point of dispensing, while wholesaler checks in between are limited to defined risk situations. The first model offers more data and visibility, the second a leaner operation. What they share is an identity unique to each pack and impossible to guess, and the fact that this identity can be consumed only once.
How serialisation works, step by step
The general flow distilled from both systems can be summarised as follows:
- Identity generation: the product code (GTIN), a random serial number, the batch and the expiry date are created together.
- Printing and checking: the code is printed on the production line and its readability and print quality are checked.
- Registration: the identities created are notified to the central system.
- Events along the chain: warehouse, distributor and point-of-sale notifications (İTS) or risk-based checks (FMD) take place.
- Verification at the final point: the code is verified and closed when the product is handed to the end user.
- Anomaly detection: when a code that has already been closed, or was never registered, is read, the system raises an alert.
The strongest part of this structure is in the final steps. A copied code shows up as an identity seen a second time, because the genuine product has already been registered or consumed. The anti-tampering device protects against the scenario where the code is correct but the contents have been changed.
Lessons for food supplements and cosmetics
In neighbouring categories the regulatory framework runs through different institutions. Food supplements fall under the Ministry of Agriculture and Forestry's food legislation. Since 2 October 2024 the ministry has published imitated or adulterated foods and products that may endanger health, as identified in inspections, in real time on its Reliable Food portal. Cosmetic products are registered in the Product Tracking System (ÜTS), which TİTCK runs alongside medical devices and biocidal products. These mechanisms are important tools for registration and market surveillance. A brand's ability to verify its own product in the field, at pack level, and to see channel movements, usually calls for an additional structure.
There is data showing the risk is concrete. The 2025 OECD and EUIPO report lists cosmetics, alongside pharmaceuticals, food and toys, among the counterfeit product categories carrying health and safety risks. The WHO, for its part, notes that sales of medical products through unauthorised websites make it easier for falsified products to reach consumers.
The main lessons that can be carried from the İTS and FMD experience into these categories:
- An unguessable unique identity: sequential numbers can easily be derived. The FMD's requirement for random serial numbers is a good reference for voluntary schemes too.
- Single-use verification logic: closing the code when it reaches the end user, or flagging reads after the first one, makes copied codes visible.
- Thinking about the code and physical security together: the FMD's pairing of the unique identifier with an anti-tampering device is an acknowledgement that a printed code is not enough on its own.
- Using standards: according to GS1, GS1 DataMatrix is used to meet pharmaceutical traceability legislation in more than 75 countries, including Türkiye. Standard identifiers make integration with business partners easier.
- Linking transport packaging to the product: the extension of İTS to cover transport packaging shows the value of tying case- and pallet-level identities to individual products.
- Scaling to the risk: where there is no obligation, there is no need to start with the whole portfolio; the products most exposed to counterfeiting and with the highest unit value can come first.
For brands that want to apply these principles voluntarily, Spectrace's solutions adapt the logic used in pharmaceuticals to an existing production setup. Tagvex records every change of hands from the line to the warehouse, the dealer and the customer through unique numbering at batch or unit level, and flags a copied code as an unexpected or repeated read. Grafex makes the packaging itself verifiable with an invisible signature embedded in the existing packaging design. Staff, dealers and consumers can verify with the mobile app on a smartphone; no separate reader device is needed.
Conclusion
İTS and the FMD show that serialisation is not just a barcode: an unguessable identity, central registration, events along the chain and verification at the final point together form a system. Food supplement and cosmetics brands do not have to copy that architecture one to one. But applying these principles, tested over years, scaled to their own level of risk, is a sound way to make counterfeit products and out-of-channel movements visible.
Sources
- TİTCK, Pharmaceutical Track and Trace System (İTS) (Turkish), 2026
- İEİS, Pharmaceutical Track and Trace System (Turkish), 2026
- EUR-Lex, Directive 2011/62/EU on falsified medicinal products, 2011
- EUR-Lex, Commission Delegated Regulation (EU) 2016/161 on safety features, 2016
- WHO, Substandard and falsified medical products, 2024
- TİTCK, Product Tracking System (ÜTS) (Turkish), 2026
- Ministry of Agriculture and Forestry of Türkiye, Imitated and adulterated food lists to be shared in real time (Turkish), 2024
- OECD/EUIPO, Mapping Global Trade in Fakes 2025, 2025
- GS1, The key role of GS1 DataMatrix barcodes for product identification in healthcare, 2021
