|Alert code (FiMVS)
|The batch identifier mismatches the recorded batch identifier.
|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.
Possible root causes of the alert:
- The information printed on the pack differs from the data uploaded to EMVS.
- The data of the transaction differs from the information printed on the pack.
- Scanner configuration error (batch ID contains capital and small letters which interchange or special characters change).
- Scanning errors or erroneous data change after the barcode has been scanned (batch ID is missing one or more characters, or extra characters have appeared after the batch ID, often the EAN code or the beginning of it).
- Manual data entry error.
|Alert handling procedure
Pharmacy/ Hospital pharmacy/ Dispensary/ Wholesaler
- Check the data of the transaction in the pharmacy system (if possible).
- Compare the data of the transaction (especially the batch data) to the human readable data on the pack. If the data matches, the most probable cause is that the batch data differs from what has been uploaded to the EMVS. In this case, move directly to point 6.
- If the transaction data (batch data) does not match the data on the pack, scan the 2D code again. If this is successful and does not generate an alert, the pack can be dispensed.
- If this still fails, try using another scanner or enter the information manually. If the 2D code scanning or manual entry is successful and no alert is generated, the pack can be dispensed. NOTE. If the 2D code cannot be scanned and the human readable data is also illegible, the pack must not be dispensed. The pack must be reported to the MAH as a product defect.
- If scanning is successful with one scanner but not another, the problem could stem from the scanner’s configuration. Check that the scanner has been correctly configured. Contact your IT supplier to solve this. The scanner should read and transact data without changing it in any way.
- If the pack cannot be dispensed, it should be put aside, and investigations should continue with the MAH. Alerts should be notified to the MAH through the wholesaler’s product defect system or directly via email or phone. Notifications must include the pack’s human readable data, 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.
|MAH / OBP
- Check the batch ID and serial number in the alert message, is the serial number linked to the batch and does the data match the data uploaded to EMVS?
- If the data differs, the batch data printed on the pack may differ from the batch data uploaded to the system, or there is an error with the scanner or an error in manual data entry.
- If the end user does not contact the MAH/OBP, FiMVO (email@example.com) may be asked to check the pack’s audit trail. Often the alerting pack has been successfully verified and/or decommissioned after the alert. In this case the end user does not usually contact the MAH/OBP. FiMVO can also contact the end user in question, if necessary.
- If the end user requests clarification with an attached photograph of the pack, check that the 2D code on the pack has the correct information. In addition, check also that the 2D code data is the same as data uploaded to EMVS.
- If the data on the pack differs from the data uploaded to FiMVS, the MAH should, if necessary, request the distributor to place a sales ban on the batch for the duration of the investigation and work with the OBP to solve the situation. The MAH should pay particular attention to informing pharmacies, wholesalers and Fimea in order to keep them up to date of the situation and to ensure uninterrupted treatment and patient safety.
- If the investigations confirm that this is a genuine falsified medicine, the product defect process should be followed (Class 1 product defect). The MAH is responsible for the planning and implementation of the required actions. Fimea oversees that the measures are adequate and appropriate. (https://www.fimea.fi/web/en/supervision/pharmacovigilance/product_defec…).