The Latvian Medicines Verification Organization (LZVO) provides guidance on the actions to be taken by the end user when the system displays an NMVS_NC_PC_01 (Unknown product) error notification with the package status "UNKNOWN" during the verification process of a medicine package, but no alert is generated.
In general, different types of transaction errors in the medicines verification system can generate various system notifications. These notifications are categorized into 5 levels, and only the highest level, L5, generates alert that require an alert investigation. The other lower-level L1-L4 errors also generate system notifications that are visible to end users. In these cases, end users should act on the notification received and correct the error, such as changing the password, not distribute the expired medicine, etc.
PC_01 is an L3 error. The NMVS_NC_PC_01 code indicates that the scanned product could not be found either in the Latvian system or in any other national verification system.
In the case of a PC_01 error:
- Only the end user can see both the package and the information written on it, as well as the notification (L1-L4) with the error code on the screen, and they must initiate the investigation.
- The end user is advised to check whether the product is subject to the EU Falsified Medicines Directive (FMD), and if so, compare the data available in the system with those printed on the package in human-readable form.
- The end-user checks whether the medicine was purchased from within the EU.
- If the product is subject to the FMD, it cannot be dispensed.
- The end-user contacts the MAH regarding the product's status, its correct data upload, and/or correction.
- If it is not possible to successfully upload the medicine into the system, the end-user follows their quarantine and return procedure for medicines.
- If the manufacturer correctly uploads the medicine data into the system and the end-user can verify this, the medicine can be sold or used/realized.
- If necessary, the end user involves LZVO and/or the competent authorities.
Possible reasons for the PC_01 error notification:
- This product is not subject to the FMD, such as a medical device or a dietary supplement.
- This product was purchased from a non-EU country, such as the United Kingdom.
- The manufacturer has not correctly uploaded the product data into the system.
- The product code is being interpreted incorrectly by the end-user's scanner/software.
In Latvia, the investigation of alerts (L5 level errors) should follow the EMVO Alert Handling Guidelines.