Conference Halle A4 CHEManager / Wiley-VCH Verlag GmbH & Co. KGaA
10:00-11:30 h | Hall A4 Forum III
Subjects: rail freight | pharmaceutical / chemicals logisitcs | infrastructure / transport policy | dangerous goods | digitalization
Speech: German, English
We cannot afford false economies in the quality and security of pharmaceutical transport. What is directly at stake here is the health of patients. To increase the security of the pharmaceuticals supply chain, the EU GDP (good distribution practice) Directive was amended in 2013. This was followed, on 9 February 2019, by the entry into force of another EU Directive, the Falsified Medicines Directive (FMD). Among other things, it stipulates that prescription-only medicines should henceforth be brought onto the market exclusively in packaging showing the serial number with a tamper-evident closure. The goods have to be validated at the point of sale before they are issued to the customer.
But what happens if serialised goods are damaged, contaminated, sabotaged or stolen during transport? What security technology is available? When should the authorities be called in and who bears the liability risks?
Implementing the FMD continues to raise questions. But the effectiveness of the GDP amendment itself has caused controversy. Not least, there is the question of whether its implementation is being adequately supervised to guarantee the required quality of pharmaceutical transport.