Serialization – FMD Compliance
After 09th Feb 2019 the serialization of prescription drugs will be mandatory according to the EU – Delegated Regulation (EU) 2016/161 called the Falsified Medicine Directive (FMD). Serialization and labeling systems are intended to prevent from illicit drug counterfeiting.
We are currently developing a central software solution for the control and monitoring of serialization and track & trace processes. Lichtenheldt will be able to generate, manage and distribute unique serial numbers on manufacturing lines. By the middle of 2017, we will also start up corresponding aggregates on our packaging lines to enable serialization, control weights, tamper-evident and continuous aggregation, inline.
The basic requirement for the safety against counterfeiting of a drug is the allocation of a unique serial number in conjunction with individual production data (product identification GTIN / NTIN / PPN, expiration date and lot number) in the form of a data matrix code. This distinctive feature ensures the protection against manipulation of a medicament unit in combination with tamper evident seal labels on the folding box.
The data shall be printed both in plain text and in machine readable form. Through serialization, each packaging unit has a unique identity with an individual number. In the pharmacy, at the time of delivery to the customer, the serial number of the package is verified against the manufacturer’s data. A so-called end-to-end verification is assured.