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FMD compliance

Supply chain track and trace of pharmaceutical products

Track & Trace | Serialization | Aggregation - tailor-made complete solution for the pharmacy

FACTS:

According to the World Health Organization (WHO), 10 percent of medicines WORLDWIDE are counterfeit, in developing countries up to 30 percent

Counterfeit medicines pose a serious health risk. Counterfeit medicines are also a matter of safety and, in the worst case, patient survival

Counterfeit medicines no longer only affect so-called lifestyle products, but also cancer medicines, medicines to treat cardiovascular problems, antibiotics...

 

SITUATION:

In order to increase security in the regular supply chain, the EU issues additional requirements for security measures. Since February 2019, the packaging of prescription drugs must be provided with a tamper protection - e.g. a seal label.

 

The medication will be checked for authenticity by a scan in the pharmacy when it is dispensed. Before the drug is passed on to the patient, the pharmacist checks an identification code for each drug. 

 

For this purpose, medicines are given packaging-specific serial numbers that are stored in a protected database. If a pack with an unknown number or one that has already been scanned is found, the system sounds an alarm.

THE SAFE SOLUTION:

TRANSPARENCY from production to the patient through:

  • Identification of each folding box with a unique serial number

  • Aggregation of the individual folding boxes in the next packaging unit (e.g. carton)

  • Aggregation of the packaging units to the shipping unit (e.g. pallet)

  • Global delivery of serial number and aggregation data 

The advantages are apparent

  • An important step in the production of safe medicines

  • Improvement of quality management

  • Documentation of the supply chain from the manufacturer to the end user

  • Reduction in product aging within the supply chain

  • Improvement in product data accuracy and preservation of this data

  • New possibilities in CRM (customer relationship)

  • Improved product safety and increased customer confidence

  • Ensuring corporate earning power by avoiding product piracy