Detecting falsified medicines

16.10.2023

The BfArM is currently warning against falsified medicines. The securPharm system detects such counterfeits and makes it possible to identify and withdraw these products from circulation at wholesalers level or upon delivery to pharmacies. With an obligatory check by means of a scan immediately before dispensing to patients, it can be ruled out that they are dispensed via the regular trade.

With the securPharm system, pharmaceutical manufacturers and pharmacies in Germany are implementing the EU’s Falsified Medicine Directive (FMD). The task of the securPharm system is to check a package of medicinal products by means of an unique package number. This ensures that it has entered the supply chain of the respective European country legally. Each pharmaceutical manufacturer is obliged to provide each individual package with an individual package number and to transmit this to a higher-level database, which in Germany is the securPharm system. Security controls ensure that only legitimate companies can upload data into the system.

When a pharmacy dispenses a medicine, the characteristic is checked. If it matches and the medicine is displayed as “not booked out”, the pharmacy can be confident that the package is safe and can be dispensed to patients. In case of discrepancies, a corresponding and unambiguous warning message is issued. In these cases, the pharmacy is obliged to quarantine the package and not to dispense it.

For patients, therefore, the following applies: There are very high security standards for medicines that are obtained through the legal distribution chain. For the patient, direct purchase from a pharmacy is the safest way. On the other hand, anyone who obtains medicines from non-legal sources, e.g. via unauthorised dealers on the Internet, runs the risk of acquiring counterfeit or stolen medicines, the effects of which can be hazardous to health.

In the current case, securPharm is in exchange with the responsible supervisory authorities and supports them with corresponding analyses and information in their investigation.