How do you show that what is inside the carton is your product?

Packaging grows easier to copy every year. When the carton, colour and print are reproduced exactly, no distinguishing mark is left in hand.

Implementation

Lumvex in pharmaceuticals.

A signature is applied to the packaging and, where needed, to the product itself; your packaging design does not change. At the wholesaler, in the pharmacy and during audits, the product is shown to be yours on the spot. Every reading is recorded with its place and time, ready for audits and legal proceedings.

We support pharmaceutical manufacturers so they can show in the field that their product reaches the patient exactly as it left them.

Situations met often in this industry: a counterfeit carton cannot be told from the real one by eye; you cannot decide on a suspect product at the wholesaler; you cannot confirm that a returned carton came from you; you keep no record to support a counterfeiting claim.

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Data

The scale of counterfeit risk.

1 in 10

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, 2024

$30.5 billion

Estimated annual spending by countries on substandard and falsified medical products

Source: World Health Organization, Substandard and falsified medical products fact sheet, 2024

4.4%

Share 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, 2016

Risks

Risks in pharmaceuticals.

Patient safety

A counterfeit medicine is directly a health matter; the speed of detection decides the outcome.

Channel integrity

Product leaving the authorised channel creates both reputational and legal exposure.

Audit expectations

Auditors and large buyers want proof of the product safety measures you take.

Example scenario

A product’s journey from production to verification.

Signed in production
The signature is applied while the carton is printed; the fixed reader on the line catches a carton with a missing or weak signature before the packaging closes.
Leaving the site
Cases are read as they are shipped; each reading is recorded with its place and time.
Warehouse intake
At the wholesaler, the arriving product is confirmed as yours on the spot at intake.
Field check
In the pharmacy and during audits your field team reads the carton with a handheld reader; the result arrives on the spot and lands in your reports.

Regulation

Regulations relevant to traceability.

Pharmaceutical Track and Trace System (İTS)

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.

Official source

Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161

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.

Official source

This section is for information only; official sources prevail for current obligations.

FAQ

Questions about pharmaceuticals

Does the signature change how the product or packaging looks?

No. The signature cannot be seen with the naked eye; the colour, texture and packaging design of your product stay exactly as they are.

Who can carry out verification?

At the wholesaler, in the pharmacy and during audits, your teams get a result on the spot with registered readers. Every reading is recorded with its place and time, ready for audits and legal proceedings.

Other industries

All industries