In pharmaceutical products it is vital that the source and the distribution chain can be verified.
Implementation
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.
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.
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Data
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
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.
Regulation
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; official sources prevail for current obligations.
FAQ
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.
Company staff, distributors, pharmacists, patients and auditors can verify with the mobile app installed on a smartphone. No special reader device is needed.
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Meeting request
The first meeting reviews your product, sales channels and the risks you face, and recommends a suitable method.
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