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
|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 (email@example.com) 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: (firstname.lastname@example.org).