Belgium
As previously announced, since 9th of Feb 2024, Belgium and Luxembourg switched to a full EU-FMD implementation.
The Belgian NCA (FAGG / AFMPS / FAMHP) now published Circular 654 for the attention of the inspectors involved in the control of the distribution chain of medicines. The letter concerns the handling of FMD alerts by users in the context of verifying packages of medicines using the Belgian Medicines Verification System (BeMVS) and the alert management system (NMVS Alerts).
In the circular, the FAMHP stresses the importance of the correct and effective use of the system by all relevant actors in the drug distribution system, including the necessary quarantine procedures if the system generates an alert when verifying or decommissioning medicines.
Practically speaking, therefore, the actors involved in an alert must keep the product quarantined until such time as a clear explanation is found for the alert, and it can then be confirmed that the product was correctly decommissioned.
Currently, all actors involved are connected to the system. In addition, the so-called “alert rate” appears to be smaller than 0.05% of the number of verified drugs. In addition, a system is made available by EMVO and BeMVO to enable dealing with an alert in a systematic and efficient manner.
Therefore, FAMHP expects that the correct procedures, including quarantine, are systematically followed in the event of an alert, and requests their inspectors to pay the necessary attention during inspections to ensure that:
- quarantine rules, particularly at the level of pharmacies open to the public, hospital pharmacies and distribution licensees, are correctly followed in the event of an alert. Therefore a number of rules were worked out in consultation between BeMVO and the FAMHP and communicated to users via the BeMVO website. These should be used when handling and, if necessary, escalating alerts. These rules were also communicated internally;
- working with the BeMVO system was correctly documented in the quality systems of the actors involved;
- all actors involved use the system effectively and continuously. In case of technical problems, the actors involved take the necessary measures to solve these problems as quickly as possible;
- those responsible for placing medicinal products on the market, in the event of any problems with uploading the data into the database take the necessary steps to add the missing data as soon as possible, or correct incorrect data as soon as possible;
- where required, take enforcement action through formal warnings. And if necessary, make proposals for amicable settlements, or by drawing up an official report in cases where, after warning, the actors concerned do not take the necessary action to follow them or fail to draw up and implement adequate corrective action plans.