In pharmaceutical products it is vital that the source and the distribution chain can be verified.
Industry overview
In pharmaceuticals, authenticity is directly a matter of patient safety. According to the World Health Organization, at least one in ten medicines in low- and middle-income countries is substandard or falsified, and these products are often sold through online or unregistered channels. A falsified medicine deliberately misrepresents its identity, composition or source; it can leave treatment ineffective and put the patient's health at risk. That is why having every change of hands in the supply chain on record is a basic expectation in this sector.
In Türkiye, the Pharmaceutical Track and Trace System (İTS), running since 2010, makes medicine packs unique with a data matrix code and records their movements; in the EU, the Falsified Medicines Directive requires a unique identifier and an anti-tampering device on the outer packaging. While these statutory systems continue unchanged, pharmaceutical companies may also need to monitor distribution in export markets, the authenticity of the outer carton and how their brand is used in online channels. Spectrace provides a layer of evidence and records that works alongside the statutory systems.
Figures
Minimum share of medicines that are substandard or falsified in low- and middle-income countries
Source: World Health Organization, Substandard and falsified medical products fact sheet, 2024Estimated annual spending by countries on substandard and falsified medical products
Source: World Health Organization, Substandard and falsified medical products fact sheet, 2024Share of sales lost by the sector in the EU because of falsified medicines (around €10 billion a year)
Source: EUIPO, The economic cost of IPR infringement in the pharmaceutical industry, 2016Risks
Every industry has its own risk profile; solutions are configured around those risks.
A product with no active ingredient or the wrong composition can leave treatment ineffective and put the patient's health at risk. When the outer packaging is printed very close to the original, a falsified product becomes hard to spot.
The World Health Organization notes that online sales on unauthorised sites make the problem worse. Sites and social media accounts using the brand name and carton images can broker uncontrolled sales.
Products sent abroad can be counterfeited in markets where the tracking infrastructure is different or absent. In those markets an additional verification tool may be needed to show the pharmacist and the patient that the carton is genuine.
Products allocated to a particular country or tender can be diverted to other markets. This weakens control over storage conditions and the distribution chain.
Our approach
Grafex, Tagvex and Authex can be used together or separately in any industry.
Smart packaging
An invisible signature is worked into the packaging; a copy cannot pass verification.
Grafex sitesi
The invisible signature is worked into the existing design of the outer carton and printed on your existing line; the İTS data matrix code and the statutory packaging information stay exactly as they are. A pharmacist, a distributor, a field team member or a patient can scan the carton with the mobile app and confirm that the packaging is the company's own print.
Secure labels
A unique number for every product; every step from production to customer is recorded.
Tagvex sitesi
It does not replace the statutory data matrix code; it provides an additional layer of records at batch or unit level, particularly in export markets and for sample products. Line exit and deliveries to the warehouse, the distributor and the pharmacy are recorded. Unexpected or repeated scans are flagged as possible duplicate codes.
Digital monitoring
Brand risks in digital channels are detected, prioritised and turned into action with evidence.
Authex sitesi
Online sales sites, marketplace listings, social media accounts, digital advertising, domain names and app store records using the brand or product name without authorisation are monitored. Detections are documented with their date and content. Takedown requests are filed and followed to conclusion; whether removed content reappears is also monitored.
Example scenario
The outer carton is printed with the invisible signature on the existing line; alongside the statutory data matrix code, a Tagvex number is assigned to export batches.
Cases are scanned on leaving the warehouse and on delivery to the distributor in the destination country; which batch went to which market is recorded.
The pharmacist in the destination market scans the delivered carton with the mobile app and sees that it is genuine and came through the right channel.
The patient or a relative scans the carton with their phone. Meanwhile Authex continues to monitor unauthorised online sales of the same product.
Regulation
The main rules that apply in your industry, or will soon take effect.
Established by the Ministry of Health in 2010, İTS makes medicine units unique with a data matrix code and records production, import, export, purchase and sale movements with location and time information. Citizens can also check a medicine through the mobile app and online enquiry services.
Requires a unique identifier and an anti-tampering device on the outer packaging of medicines; the detailed rules on these safety features have applied since 9 February 2019. The directive also introduces a common EU logo for legal online pharmacies and strengthened record-keeping obligations for wholesale distributors.
This section is for information only; rely on official sources for current obligations.
FAQ
No. The İTS data matrix code and the EU's unique identifier and anti-tampering device are legal obligations and continue to apply unchanged. Spectrace is an additional layer alongside those systems that proves the authenticity of the packaging and keeps the brand owner's own distribution records.
The invisible signature is worked into the existing design and printed on your existing line; the look of the carton and the placement of statutory information do not change. Assessing any change to packaging from a marketing-authorisation perspective remains the responsibility of your regulatory affairs team.
In markets with different tracking infrastructures, the pharmacist, the distributor and the patient can confirm the carton is genuine with the same mobile app. Tagvex records show which batch was sent to which distributor and country.
Company staff, distributors, pharmacists, patients and auditors can verify with the mobile app installed on a smartphone. No special reader device is needed.
Authex detects these sites, listings and accounts and documents them with their date and content. Takedown requests are sent to the relevant platforms and domain providers and followed to conclusion; whether removed content reappears is also monitored.
Blog
How Türkiye's İTS and the EU Falsified Medicines Directive run serialisation, and what supplement and cosmetics brands can learn.
8 min read
What batch numbers, unique serial numbers, GTIN, SSCC, GS1 DataMatrix and GS1 Digital Link each cover, and when each one is enough.
8 min read
Smart packaging, secure labels and digital monitoring: how to choose the right method, or the right combination, by looking at where your product struggles.
3 min readOther industries
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In the first meeting we review your product, sales channels and the risks you face, then recommend a verification method that fits.
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