Batch data not uploaded in NMVS – lessons learned

We would like to highlight the importance of ensuring that batch data has been successfully uploaded in the NMVS prior to releasing the batch for distribution. Failure to do so is a violation of the Delegated Regulation (EU) 2016/161, Art. 33, and may cause harm to patients as it may lead to delays in them receiving their prescribed medications.

The situation will further escalate if the MAH/OBP chooses not to communicate the issue to all distribution chain actors. This lack of communication is especially critical if packs belonging to the batch have already been distributed to pharmacies, but pharmacies are not notified that every single pack will raise an alert when decommissioned.

The following lessons learned have been drawn up by FiMVO as a result of a recent incident which involved 1) the failure of the MAH/OBP to upload batch data before releasing the batch for distribution, 2) the apparent lack of understanding of the MAH/OBP regarding the cause for the alerts, and 3) the failure of the MAH to communicate the issue to distribution chain actors.

Lessons learned:

• The MAH/OBP must ensure that the batch data has been successfully uploaded in the EMVS before releasing the batch for sale or distribution (refer to Article 33 of Commission Delegated Regulation (EU) 2016/161).
• Finnish wholesalers voluntarily verify one pack from every new batch they receive, and this prevents similar incidents. However, if/when the MAH/OBP notifies the wholesaler that the issue of missing batch data upload has been corrected, and requests the batch to be released for distribution, wholesalers may not verify the pack again to confirm that the issue has been corrected. The MAH/OBP should always confirm that the upload of the batch has been successful by requesting the wholesaler to verify at least one pack before releasing the batch for distribution.
• MAHs/OBPs should ensure that their quality unit, logistics unit and serialization unit understand the reasons behind different types of alerts. In this case, an alert caused by missing batch data (NMVS_FE_LOT_03 Failed to find a batch for the given data / #A2) means that none of the UIs belonging to that batch have been uploaded in the EMVS. In other words, all packs belonging to that batch will raise an alert.
• MAHs/OBPs should have sufficient resources and competence to manage this type of incidents. If the issue cannot be solved within a working day or two, pharmacies and other distribution chain actors (including FiMVO) should be notified of the issue and the corrective actions planned or implemented. In this case, the batch had been quarantined at the wholesaler level, but the MAH/OBP seemed to ignore the fact that many packs had already been distributed to pharmacies and hospital pharmacies and would raise an alert when decommissioned. The confusion possibly leading to the patient not receiving his/her prescribed medication could have been avoided had the MAH/OBP communicated the issue to the distribution chain.

We also hope that our Alert Handling Guideline is helpful. It includes guidelines also for the OBPs/MAHs regarding all the different alerts.

Regarding alerts, data uploads and any other system related questions, please always use our email-address: nmvs@fimvo.fi