Alert Handling
Using the national verification system
Using the verification system correctly prevents the occurrence of false alerts for potentially falsified medicines (i.e. alerts generated by the system that do not correspond to potential falsifications, but are caused by errors of various natures). On the other hand, the implementation of preventive and corrective measures will help to avoid errors in the future. The following documents were prepared to support users of the verification system:
- General recommendations for using the national verification system (document in Portuguese)
- Measures to eliminate and prevent alerts
- Protocol for verification of scanner configuration by End-Users (document in Portuguese)
Managing alerts for potentially falsified medicines
When discrepancies are detected between the data uploaded by the marketing authorization holder or parallel import authorization holder (Authorization Holders) into the verification system and the data read by an End-User (wholesale distributors of medicines for human use, pharmacies and hospitals), or when an attempt is made to dispense or decommission the same pack more than once, an alert is generated.
Potential alerts are visible to the user who generated it, to MVO Portugal, to INFARMED, I.P. and, depending on the nature, to the Authorization Holders (for example, product unknown alerts are not sent to any Authorization Holder, as it is not possible to identify the responsible entity).
MVO Portugal has developed a set of recommendations for investigating alerts by Authorization Holders and End-Users:
These recommendations consist of a description of actions to investigate and determine the cause of an alert generated by the national verification system. These recommendations may serve as a basis for the development of internal procedures.
The recommendations prepared for Authorization Holders complement those described in the document EMVO-00306-Best Practice on Alert Handling.
Alerts – most frequent causes
The most frequent causes of alerts for potentially falsified medicines in Portugal are the following:
| Cause | References |
| Scanner issues |
To use the protocol for verification of scanner configuration by End-Users, click here (document in Portuguese). To support the configuration of the most frequently uses scanners in Portugal, click here. |
| Data not uploaded, or uploaded after the batch has been released to the market |
The Authorization Holder must guarantee that the product and pack data is uploaded into the EMVS prior to physically have the products in the supply chain. For all batches released before 9th February 2019 bearing 2D matrix codes, and all non-FMD medicines (e.g. Indian packs) must be reported via the form MVOPT-TP-0026 Non-FMD products released to the Portuguese market, and sent by email to alertas@mvoportugal.pt. The same report must be used for reporting the release of serialized batches that are not in scope of FMD (e.g. Indian packs). More information here (document in Portuguese). |
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Wrong data encoding into the 2D code. For the Portuguese market the following must be part of the 2D code:
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To support the correct encoding, check the following documents: |
| Delivery of packs with the unique identifier already inactive, when it should be active |
With the exception of cases provided for in legislation, (namely article 23 of the Delegated Regulation), packs must arrive at the point of dispensing (pharmacies or hospitals) with the unique identifier in the Active state. Likewise, 3PL acting on behalf of Authorization Holders (or Authorization Holders themselves) deliver the packs to their respective customers (wholesalers, pharmacies or hospitals) with the unique identifiers in the Active state. |
| Repeated attempt to dispense or decommission an already dispensed or decommissioned pack, by the same End-User |
Attempting to dispense or decommission an already dispensed or decommissioned pack will trigger an alert. Before carrying out a dispensing or decommissioning operation, a verification operation must be carried out to confirm that the unique identifier is in the Active state. |
