Products of unknown source
A product entering the chain from outside may be indistinguishable in original packaging.
Proof of source in pharmaceuticals and health products.
Being able to prove a product's source along the chain calls for a definitive result at the moment of dispute.
The current picture
Deeptrace in pharmaceuticals and health products.
In pharmaceuticals and health products, track-and-trace systems show which points a product passed through; that the product in your hand is the product the record describes is proven by the product itself. Fast field checks and definitive lab matching can be used together.
Request a meetingData
The scale of the problem.
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, 20244.4%
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, 2016Risks
Risks in pharmaceuticals and health products.
Evidence needed in disputes
In legal proceedings, a quick field result is often not considered enough.
Content compliance
Whether the product carries its declared composition may be questioned.
Approach
How Deeptrace approaches it.
Fast checks in the field
With Lumvex, the product's source is seen within seconds wherever it is.
Definitive matching in disputes
DNA-based marking seeks an exact match in the lab; the result is yes or no.
Measure the content
Molevex compares the composition with a reference accepted as genuine.
Regulation
Regulations relevant to the industry.
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.
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.
This section is for information only; official sources prevail for current obligations.
FAQ
Questions about pharmaceuticals and health products
Does it replace our existing traceability system?
No. The records system shows the product's path; marking and analysis prove that the product itself is that product. The two work together.
Which layer is used for daily checks?
Daily checks use a fast mark; the DNA-based layer comes in at the moment of dispute.
Does the mark added to the product affect it?
The mark is added in trace amounts; suitability is assessed per product group in the technical review.
Meeting request
The right method for your product comes from the product itself.
The first meeting reviews your product group, your production flow and the points where verification will take place, and recommends a marking or analysis method.
Request a meeting