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Information on serialisation alerts "NMVS_NC_PCK_22 Pack is already inactive.”
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Many of you are currently receiving alerts of type NMVS_NC_PCK_22. This is a critical alert in our campaign against counterfeiting because it signals that the unique identifier of a pack has already been decommissioned in the supply chain. In other words, you potentially have a pack in your hands that requires further investigation to determine whether it is a valid pack or a counterfeit pack.
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Unfortunately, the triggering of this alert is also very often linked to situations of avoidable process or system errors that we have listed below as well as to cases where the user's computer system is running in a loop and repeatedly decommissioning the same pack. These computer errors may require the software supplier to identify, diagnose, and fix the problem.
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Situations that can trigger a NMVS_NC_PCK_22 alert:
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- When the same unique identifier is decommissioned on 2 different packs, which can lead to a counterfeit confirmation after analysis of the 2 packs.
- When the same pack is decommissioned several times by the same end user.
- When the same pack is decommissioned once by the end user after already being decommissioned by another actor upstream in the supply chain (MAH, designated wholesaler, wholesaler).
- When the same pack is decommissioned by two different end users (in case of troubleshooting for example).
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What you should be aware of and how to avoid inappropriate triggering of this alert?
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- Please make sure that end users at your site only decommission each pack once:
When a pack has been decommissioned once, if the same end user scans the same pack two more times, he will get a "NMVS_NC_PCK_23 Re-setting of the property via double scan is registered" each time. Then, if the user scans the same pack a fourth time, the PCK22 alert will be triggered.
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- Please coordinate the decommissioning of the packs with your partners in the distribution chain:
- The same unique identifier can be decommissioned throughout the distribution chain by wholesale distributors, particularly under Article 22 (decommissioning for export outside the European Union) or Article 23 (decommissioning on behalf of the structures provided for in Decree No. 2019-592 of June 14, 2019). In these two cases, the end user located in France and not concerned by either Article 22 or art 23 who receives the packs of medicines already decommissioned cannot know the status of the packs and may decommission them again, which would trigger a PCK22 alert.
- The same pack may be the subject of the same transaction either by the MAH/OBP holder via his EMVS access and by the designated wholesaler via his NMVS access due to a breakdown of communication or an insufficient definition of the roles and responsibilities of the actors. This case is encountered for decommissioning in the framework of Article 22 or 23, and for the destruction of packs for example. Only one of the two actors must perform this transaction and this must have been perfectly defined beforehand. Only actors who have the packs physically in their hands can carry out transactions on these packs.
- Please remember to not decommission (even for destruction) the packs that have expired:
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Packs whose expiration date has been reached are automatically decommissioned in the NMVS. If a request is made to physically destroy these packs, do not perform the decommissioning for destruction transaction in the NMVS, which would trigger a PCK22 alert.
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* Decommissioning: do not confuse scanning and decommissioning, the scan of a pack can be performed for different purposes: validation, decommissioning, undo decommissioning, etc ... This newsletter concerns a scan to deliver a pack to a patient, so a decommissioning scan.
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Sérialisation : a requirement to ensure the safety and quality of medicines provided to patients
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