Possible root causes of this alert:
- The pack is already inactive in the system, but its state is different to the transaction process (e.g. pack is marked as Sample and the end user uses the Dispense transaction)
NOTE. This only generates an alert if the pack data is not found in FiMVS and an IMT is performed (e.g. a special license product is brought to Finland from another EU country).
||Alert handling procedures
Pharmacy/ Hospital pharmacy/ Dispensary/ Wholesaler
- Check the pack state in FiMVS (Verify).
- Undo the previous action on the pack (e.g. if the pack has been dispensed, perform Undo Dispense).
- If the undo is successful, the original transaction was performed by the same end user under 10 days ago, which suggests that the original transaction was cancelled but the end user forgot to return the pack to the system. The pack state is now active, and the pack can be dispensed from the system. The end user must investigate and record the error and take preventive action not to repeat the error.
- If undo is not possible, and the system alerts, Defined timeframe between setting this property and the undo was exceeded (NMVS_NC_PCK_20) or Undo can only be executed by the same user who previously set the attribute (NMVS_NC_PCK_21) the original transaction was performed over 10 days ago or by a different end user. This may be a falsified pack. In this case the pack cannot be dispensed until the reason behind the alert is investigated. The pack should be set aside and clearly marked that it cannot be dispensed.
- If the end user cannot see when and by whom the original transaction took place, FiMVO can check the transactions which were performed in Finland (firstname.lastname@example.org). If necessary, the end user should be in contact with the MAH or the wholesaler who can check the audit trail in the EU country where the pack data has been uploaded.
- If the audit trail implies a product defect or falsification, this must be notified to the MAH either through the wholesaler’s product defect system or directly to the MAH via email or phone. Notifications must include the human readable data of the pack, i.e. product code, serial number, batch ID and expiry date. It is helpful to send a photograph of the pack as an attachment. The photo should include the 2D code and the human readable data on the pack. N.B. The pack should not be returned to the wholesaler before the cause of the alert has been resolved and / or before the return has been agreed with the MAH.
|MAH / OBP
In this case as the pack data was not uploaded to FiMVS, FiMVO is incapable of following the audit trail. FiMVO can check the actions which were performed in Finland (email@example.com). If necessary, the MAH / OBP can check the audit trail in another EU country by contacting the support of the medicines verification organisation of that particular country.