|Alert code (FiMVS)
|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.
Possible root causes of the alert:
- The information printed on the pack differs from the data uploaded to EMVS.
- The transaction data differs from the information on the pack.
- The manually entered expiry date is in the wrong format (DDMMYY) and should be in the correct format YYMMDD.
- A typing error made whilst manually entering the expiry date.
|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 expiry date) to the human readable data on the pack. If the data are the same, the most probable cause is that the expiry date in the system differs from the one printed on the pack. In this case, move directly to point 5.
- If the data of the transaction (expiry date) 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, enter the information manually in the correct format, YYMMDD. If the 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 human readable data on the pack.
If needed, FiMVO will respond to inquiries as to what expiry date has been uploaded to FiMVS (firstname.lastname@example.org).
|MAH / OBP
- Check the alert message: Is this the same expiry date as in the system?
- If the data is different, the expiry date printed on the pack may differ from the expiry date uploaded to the system, or there is an error with the scanner or an error in manual data entry.
- If the end user is in contact and has provided a photograph of the pack, check that the 2D code on the pack has the correct information. Check that the 2D code data is the same as data uploaded to EMVS.
- If the data on the pack differs from the data uploaded, 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 with the situation and to ensure uninterrupted treatment and patient safety.
- If the investigation confirms 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…).
- If the end user does not contact the MAH, 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. FiMVO can also contact the end user in question, if necessary.