4. Alerts returned by the Medicines Verification System
Depending on the malfunction / error situation, different levels of exceptions can occur in the FiMVS system. The distribution of exceptions in these different levels L1 to L5 (described in more detail below) is based on a general definition of the architecture of the EU medicines verification system. From a technical point of view, the FiMVS system always reverts the actual return / alert code in exceptions, not the level. A complete list of all return / alert codes with their descriptions can be found in this document on FiMVO website. NOTE! The description provided by the end user software may differ from the description provided by FiMVS. Users are advised to consult their IT-supplier with regards to this aspect.
- L1: An exception that the system repairs itself. This exception is not visible to the user in any way.
- L2: The user receives notice of the exception.
- L3: In addition to the user the System Administrator (EMVO or FiMVO) receives notice of the exception.
- L4: In addition to the user more than one system administrator (EMVO or FiMVO) receives notice of the exception.
- L5: In addition to the user and system administrators, the OBP is also notified of the exception. This may be a falsified pack. L5 exceptions are alerts and each and every alert must be investigated before the pack is dispensed to the patient. If the alert is confirmed to be a false alert and/or if falsification is not suspected, the pack can be dispensed to the customer. N.B. The pack should not be returned to the wholesaler before the reason for the alert is resolved and/or return has been agreed with the marketing authorization holder. All L5 alerts are described in more detail in the table below and following paragraphs.
All L5 level alerts with messages are described in more detail in the following table:
| Alert message | Explanation | Alert code (FiMVS) | Alert code (EU Hub) | Guidelines for investigating the alert |
|---|---|---|---|---|
Unknown serial number OR The serial number is unknown. The length or format does not match what has been uploaded. Possible scanner or software malfunction. | The serial number used for the transaction does not exist in the system for this product code. Product code and batch ID exist in the system but the serial number is incorrect. | 41020001, 41020010, 41020011, 41020012 | #A3 | First check if reading the 2D code was successful. Firstly, contact the MAH, see chapter 6.2 |
| The serial number is unknown. The batch has not been found. | Neither the batch ID nor the serial number used for the transaction exist in the system for this product number. The product code used for the transaction exists in the system. | 41020002 | #A2 | First check if reading the 2D code was successful. Firstly, contact the MAH, see chapter 6.3 |
The batch identifier mismatches the recorded batch identifier. OR The batch identifier mismatches the recorded batch identifier. The length or format does not match what has been uploaded. Possible scanner or software malfunction. | The serial number used for the transaction was found for the product code, but it does not match with the batch ID uploaded to the NMVS. | 41020003, 41020007, 41020008, 41020009 | #A68 | First check if reading the 2D code was successful. Firstly, contact the MAH, see chapter 6.4 |
| The expiry date mismatches the recorded expiry date. | The expiry date used for the transaction does not match the expiry date uploaded to the NMVS. The product code, expiry date and serial number can be found in the NMVS, but the expiry date differs. | 41020005 | #A52 | First check if reading the 2D code was successful. Firstly, contact the MAH, see chapter 6.5 |
The pack cannot be supplied. OR 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 | #A7 / #A24 | Firstly, contact FiMVO, see chapter 6.6 |
The pack cannot be decommissioned. OR The pack is already decommissioned at this location. | The user attempted to decommission (not dispense) a pack that was already decommissioned. | 51320000, 51320200, 51320201, 51320300, 51320301, 51320400, 51320401, 51320500, 51320501, 51320600, 51320601, 51320700, 51320701, 51320800, 51320801, 51320900 | #A7 / #A24 | Firstly, contact FiMVO, see chapter 6.7 |
A complete list of all return / alert codes beginning with 5122 and 5132 and their descriptions can be found in this document on FiMVO website.