2011/62/EU

Also outside line production

The EU Falsified Medicines Directive (FMD) 2011/62/EU was published in 2011 and applies to all prescription-only as well as selected OTC drugs in the European Union with effect from February 2019.



Drug safety is a valuable asset, but also one which is repeatedly endangered by falsified drugs. According to an estimate by the US Food and Drug Administration (FDA), more than 10% of all drugs in circulation worldwide are believed to be counterfeit. A community code has therefore been established at EU level to prevent the infiltration of falsified medicinal products into the legal supply chain.


Implementation of the Directive affects not only pharmaceuticals which are produced and packed on large-scale production lines, but also small batches. In most cases, however, it is not cost-

effective to continually change the production line. With the udaFORMAXX, Koenig & Bauer

Coding here offers an ingenious solution. Solupharm Pharmazeutische Erzeugnisse GmbH, based in Melsungen in Germany, is one of the companies which rely on this offline system.

Millions of glass ampoules and vials

As a modern and efficient family-owned company with state-of-the-art production facilities, Solupharm is a strong and reliable partner for national and international customers. Millions of glass ampoules and vials are filled, inspected and packaged every year.

2011/62/EU

The udaFORMAXX at Solupharm processes folding cartons – including also complex designs with crash-lock bases and insertable flaps – which must be identified with a unique, serialised code for compliance with Directive 2011/62/EU.


Each individual pack must be marked with the following information:

  • Product identification number, in the format GTIN, NTIN (or PPN for Germany)
  • Batch number
  • Use-by date
  • Individual serial number of the single pack
  • National product numbers, where appropriate

Track & Trace

Equipped with a DOD inkjet for coding and an inspection system with corresponding Track & Trace software, the udaFORMAXX offers an extremely compact and cost-effective solution for separation, serialisation and aggregation. Every printed code is verified with a camera system and recorded in the database. Folding cartons whose codes are rated as “poor” during camera scanning are automatically ejected via the udaFORMAXX reject station and subsequently removed from the database on the software side.

Solupharm GmbH

The name Solupharm has been synonymous with the responsible, high-quality contract manufacturing of sterile preparations in glass ampoules and vials for more than 40 years. The new building in Melsungen is one of the most modern production facilities in Germany. Solupharm here operates in a market where the highest manufacturing and quality standards are essential..

Alexandra Keßler