|Alert code (FiMVS)
The pack cannot be supplied.
The pack was previously supplied at this location.
|The user attempted to dispense a pack that was already decommissioned.
|51220000, 51220200, 51220201, 51220202, 51220300, 51220301, 51220400, 51220401, 51220500, 51220501, 51220600, 51220601, 51220700, 51220701, 51220800, 51220801, 51220900
A complete list of all return / alert codes beginning with 5122 with their descriptions can be found in this document on FiMVO website.
Possible root causes of the alert:
- The same user has already dispensed the pack. Before the alert is generated the user will receive the error message “The pack was previously supplied at this location.” twice and on the third time the error message “The pack was previously supplied at this location. The next attempt will be rejected.” Furthermore, the alert message will in this case state that the pack has been dispensed at this location.
- Another user has already decommissioned the pack. The alert message will in this case state that the decommissioning was performed at another location.
- In some rare cases it is possible that two packs with identical identifiers have been released on the market by the MAH and the other one of these two packs has already been decommissioned.
|Alert handling procedure
Pharmacy/ Hospital pharmacy/ Dispensary/ Wholesaler
- Check the pack status in FiMVS, if it is not evident based on the alert message.
- Undo the previous action on the pack, i.e. reactivate the pack.
- If the undo is successful, the original transaction was performed by the same user not more than 10 days ago, which suggests that the original transaction was cancelled but the user forgot to return the pack to the system. The pack state is now active, and the pack can be dispensed/decommissioned. The user must investigate the reason for the error (e.g. a shared pack which has been opened earlier and decommissioned, or a pack which was not returned to the system after not being dispensed) and take preventive action not to repeat the error.
- If undo is not possible, and the system returns the exception “The pack cannot be reactivated. Time limit exceeded.”, the original transaction was performed more than 10 days ago by the same user and the pack cannot be reactivated anymore, see chapter 6.8. If the system returns the exception “The pack cannot be reactivated. It was decommissioned/supplied at another location.”, the original transaction was performed by a different user. This may be a falsified pack. In this case, the pack must not be dispensed until the reason behind the alert has been clarified. The pack should be set aside and clearly marked that it cannot be dispensed. See also chapter 6.9.
- If the cause of the alert cannot be solved by the user, FiMVO can be asked to review the pack audit trail (email@example.com). This alert may also be raised when the pack data is not found in FiMVS and in those cases, the MAH / supplier should be contacted to check the audit trail from the EU country where the data is found. Support requests 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. 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 via email or phone. 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
If the pharmacy / wholesaler contacts the MAH/OBP, FiMVO can be asked to review the pack audit trail (firstname.lastname@example.org). In cases where the pack data has not been uploaded to FiMVS, FiMVO cannot review the complete audit trail of the pack. FiMVO can check the transactions which were performed in Finland. 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.