Interim status regarding the KMS/authorities` portal

Starting next week, the securPharm office will provide increased support to the German Federal Institute for Drugs and Medical Devices (BfArM) in a pilot project to analyse false positive alerts in the counterfeit protection system. As part of this process, BfArM will contact individual users who may be associated with the alerts to investigate the reasons for the alert.

As a reminder, BfArM and the supervisory authorities have been able to request audit trails for alerts from the securPharm office since 9 February 2019. In practice, the authorities use this service in connection with reported suspicious cases.

In a second step, the authorities will gradually be given their own direct access for querying audit trails. In future, only the manual request to the securPharm office will be eliminated.

However, other reporting functions that have been developed and finalised between the European Medicines Verification Organisation (EMVO) and a working group of the European Commission and the Member States are not yet available to the authorities. We will inform you in good time about the completion and integration of public agencies with the fully automated public agency reporting system in Germany, which is still under development.

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