Information on Legacy Packs

We all are looking forward to the upcoming implementation date of the EU Falsified Medicines Directive on February 9th, 2019. Together with you, we are sure that we will master the basic requirements and experience a successful start.

In the remaining time, we would like to clarify the open issues also together with you. Following the discussions during the 11th securPharm / ACS customer symposium on November 5th, 2018, differentiation of legacy packs is one of these issues.

To clarify the addressed questions, please find our explanations here:

  1. For pharmaceutical companies, which uploaded their data (product master data and pack data) correctly and complete via the EU Hub into the EMVS from the beginning, no systemic problems will occur.
  2. For all products, which pack data were locally uploaded correctly and complete into the ACS-MAH-System, also no systemic problems will occur, if the dispensing location is established in Germany.
  3. For a transition period the following cases may lead to undesired alert messages during the dispense:

- a.    Locally into the ACS-MAH-System uploaded packs, which batch information is unknown to the EU Hub and which are dispended abroad; the problem can be remedied relatively easy by forwarding all batch information already sent to ACS-MAH-System before February 9th, 2019, to the EU Hub retrospectively.
- b.    Uploaded packs with incorrect pack data in the ACS-MAH-System or the EU Hub
- c.    Packs with Data Matrix printed, which pack data have not been uploaded to the ACS-MAH-System via the EU Hub or national upload

The batches related to 3.a. have already been identified. We will contact the companies concerned and will initiate the required steps to prevent potential problems.

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