In order to contain counterfeit pharmaceuticals, the authorities have established internationally uniform standards (Directive 2011/62/EU and the Delegated Act) for the serialization of prescription drugs. Since 2019, every pharmaceutical package must therefore be marked with a unique and counterfeit-proof serial number. The EU directive provides four indications: PPN/NTIN (01 GTIN), expiry date (17 EXP), batch number (10 LOT) and an individual serial number (21 SN). In addition, the packaging must have tamper evident protection.
For pharmaceutical contract manufacturers, this results in new requirements for the serialization of drug packaging:
The IT infrastructure must therefore ensure simple and efficient data exchange with other systems. It requires a system that supports communication both with the client's systems and with its own printing facilities. SecIdent Pharma fulfills exactly these requirements and offers a solution for secure serialization that is precisely tailored to the pharmaceutical industry.
The requirements resulting from the Counterfeiting Directive offer CMOs the unique opportunity to make a greater contribution to value creation through the holistic and secure process, thereby expanding their business model.