5.5 Unknown serial number (NMVS_NC_PC_02)

Possible root causes of the alert:

Not all serial numbers in the batch have been uploaded to EMVS.
The data in the transaction differs from the data printed on the pack.
- Scanner configuration error (serial number contains capital and small letters which interchange).
- Scanning errors or erroneous data change after the barcode has been scanned (serial number is missing one or more characters, or extra characters have appeared after the batch ID, often the beginning of the EAN code).
- Manual data entry error.

End user	Alert handling procedures
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 serial number) to the human readable data on the pack. If the data is the same as the human readable data on the pack, the most probable cause is that not all serial numbers in the batch have been uploaded to EMVS, even though the product’s master and batch data can be found N.B. The pack does not need to be verified numerous times/on consecutive days. Investigations should begin as soon as it has been confirmed, that the 2D code reading has been successful. In this case, move directly to point 6. If the data of the transaction (serial number) does not match the human readable data, 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. It may be a falsified pack. Alerts should be notified to the MAH through the wholesaler’s product default system or directly to the MAH via email or phone. The notification 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 serial number in the alert message, does it match the data uploaded on EMVS? a) If no: t could be a scanning error by the end user or incorrect manual data entry by the end user, or a genuine falsification. If you have received a photograph of the pack from the end user, ensure that the data in the 2D code 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 of the pack in the FiMVS system if the MAH/OBP can find in the batch data the serial number that differs only to a small extent from the erroneous serial number. Often the alerting pack is successfully verified after the alert due to a data entry error. If needed FiMVO can contact the user. NOTE! If the investigations confirm that this is a genuine falsified medicine, the product defect process should be followed (Class 1 product defect). 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. The MAH is responsible for the design and implementation this process. 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 not all serial numbers in this batch have 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 serial numbers to FiMVS or if the data uploaded was 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).

End user

Alert handling procedures

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 serial number) to the human readable data on the pack. If the data is the same as the human readable data on the pack, the most probable cause is that not all serial numbers in the batch have been uploaded to EMVS, even though the product’s master and batch data can be found N.B. The pack does not need to be verified numerous times/on consecutive days. Investigations should begin as soon as it has been confirmed, that the 2D code reading has been successful. In this case, move directly to point 6.
If the data of the transaction (serial number) does not match the human readable data, 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. It may be a falsified pack. Alerts should be notified to the MAH through the wholesaler’s product default system or directly to the MAH via email or phone. The notification 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 serial number in the alert message, does it match the data uploaded on EMVS?

a) If no: t could be a scanning error by the end user or incorrect manual data entry by the end user, or a genuine falsification. If you have received a photograph of the pack from the end user, ensure that the data in the 2D code 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 of the pack in the FiMVS system if the MAH/OBP can find in the batch data the serial number that differs only to a small extent from the erroneous serial number. Often the alerting pack is successfully verified after the alert due to a data entry error. If needed FiMVO can contact the user.

NOTE! If the investigations confirm that this is a genuine falsified medicine, the product defect process should be followed (Class 1 product defect). 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. The MAH is responsible for the design and implementation this process. 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 not all serial numbers in this batch have 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 serial numbers to FiMVS or if the data uploaded was 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).