6.3 The serial number is unknown. The batch has not been found

Alert message	Explanation	Alert code (FiMVS)
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

Possible root causes of the alert:

Batch data has not been uploaded to the EMVS system.
The data used for the transaction (batch ID AND serial number) differs from the data printed on the pack.
- Scanner reading error or erroneously changed scanned data.
- Manual data entry error.

Actor	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 batch ID and serial number) to the human readable data on the pack. If the data (both batch ID and serial number) are the same as the human readable data on the pack, the most probable cause is that the batch data has not been uploaded to EMVS. In this case, move directly to point 5. If the transaction data (batch ID and serial number) 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 data 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 the transaction is not successful, the pack 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 alert message: Is this the correct batch number for this product? a) If no: it could be a scanning error by the end user or incorrect manual data entry by the end user. If you have received a photograph of the pack, ensure that the 2D code data on the pack is correct. Also, make sure that the 2D code data is identical to the data uploaded to EMVS. If the end user has not made contact, FiMVO (nmvs@fimvo.fi) can check the audit trail in the FiMVS system. Often the alerting pack has been successfully verified after the alert due to a data entry error. If needed, FiMVO can also contact the end user. NOTE! If incorrect batch data has been printed on the pack, this is a product defect or a possible suspected falsification. The responsible MAH should request the wholesaler, if necessary, to place a sales ban on the batch for the duration of the investigation and perform the investigation together with the OBP. The MAH should pay particular attention to informing pharmacies, wholesalers and Fimea in order to keep them up to date with the situation and to ensure uninterrupted treatment and patient safety. If the investigations confirm that this is a 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…). b) If yes: it is likely that the data for this batch has not been uploaded to the EMVS. The MAH should, if appropriate, ask the distributor to place a sales ban on the batch for the period of the investigation. If the reason for the alert is that the OBP has not uploaded the batch data to FiMVS or if the data upload has been unsuccessful, the data should be uploaded without delay, and the MAH should inform all actors in the supply chain and FiMVO of the situation, and when the data has been uploaded successfully. If needed, FiMVO will respond to inquiries as to whether the batch data has been uploaded to the FiMVS system: (nmvs@fimvo.fi).

Actor

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 batch ID and serial number) to the human readable data on the pack. If the data (both batch ID and serial number) are the same as the human readable data on the pack, the most probable cause is that the batch data has not been uploaded to EMVS. In this case, move directly to point 5.
If the transaction data (batch ID and serial number) 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 data 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 the transaction is not successful, the pack 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 alert message: Is this the correct batch number for this product?

a) If no: it could be a scanning error by the end user or incorrect manual data entry by the end user. If you have received a photograph of the pack, ensure that the 2D code data on the pack is correct. Also, make sure that the 2D code data is identical to the data uploaded to EMVS. If the end user has not made contact, FiMVO (nmvs@fimvo.fi) can check the audit trail in the FiMVS system. Often the alerting pack has been successfully verified after the alert due to a data entry error. If needed, FiMVO can also contact the end user.

NOTE! If incorrect batch data has been printed on the pack, this is a product defect or a possible suspected falsification. The responsible MAH should request the wholesaler, if necessary, to place a sales ban on the batch for the duration of the investigation and perform the investigation together with the OBP. The MAH should pay particular attention to informing pharmacies, wholesalers and Fimea in order to keep them up to date with the situation and to ensure uninterrupted treatment and patient safety. If the investigations confirm that this is a 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…).

b) If yes: it is likely that the data for this batch has not been uploaded to the EMVS. The MAH should, if appropriate, ask the distributor to place a sales ban on the batch for the period of the investigation. If the reason for the alert is that the OBP has not uploaded the batch data to FiMVS or if the data upload has been unsuccessful, the data should be uploaded without delay, and the MAH should inform all actors in the supply chain and FiMVO of the situation, and when the data has been uploaded successfully.

If needed, FiMVO will respond to inquiries as to whether the batch data has been uploaded to the FiMVS system: (nmvs@fimvo.fi).