Since February, 9th 2019, Germany has been subject to the European regulations on the protection of medicinal products against counterfeiting. Prescription drugs that are placed on the market from this date on, must now have individual identification features.
The following 3 features are intended to increase protection in the future:
- Data Matrix Code: Each new package carries a small square code that can be read by pharmacies. Only if the ‘test’ is positive may the drug be handed over to the customer.
- Individual package number (SN): Each package now also contains a sequence of 20 digits and letters that make each package unique. This number is also hidden in the Data Matrix code.
- First opening protection: To prevent packages from being opened unnoticed and contents from being falsified, each package is provided with first opening protection. This consists of glued flaps and a plastic seal or perforation line.
- Medicinal pack with new safety features (sample pack; a drug called “Tripapolon” does not really exist)
- The securPharm system
In future, pharmaceutical manufacturers will save all package numbers they have printed on medicines in the protected securPharm database. Wholesalers, pharmacies and clinics are also connected to this system so that the medicines can be traced.
As the changeover will take several months, previous packaging (until February 9th 2019) may continue to be sold and used until the end of its shelf life.
Do you need advice on your products? Our pharmaceutical laboratories will be happy to support you!
Contact Dr. Yvonne Pfeifer:
P +49 30 206 038 164