The Belgian Medicines Agency (FAGG/AFMPS) has published a document with practical recommendations for the implementation of FMD
Please find the information here
The Belgian Medicines Agency (FAGG/AFMPS) has published the legislation related to FMD.
You can find the information here (NL) (FR)
This document sets out frequently-asked questions and answers regarding the implementation of the rules on the safety features for medicinal products for human use
Reminder from the Belgian Authorities (Medicines Agency) with regards to the Human Readable text next to the 2D matrix code:
The product code (GTIN) must always be preceded by “PC”
The serial number (UI) must always be preceded by “SN”
The Belgian national institute for health insurance RIZIV/INAMI has published new legislation related to the implementation of the Falsified Medicines Directive, more specifically concerning the replacement of the linear unique barcodes with the 2D matrix information (FMD unique codes).
Hereby the related documents:
Technical document for End Users and Software Suppliers on how to handle incidents and alerts being generated by the Verification system.
NMVS – Incidents mngt – 20181001
Procedure to be followed by all stakeholders in case of an alert indicating a potential falsification.
FMD – Falsification alerts – 20181001
This document sets out frequently-asked questions and answers regarding the implementation of the rules on the safety features for medicinal products for human use https://bemvo.be/qa_safetyfeature_en_v11/
The Belgian Medicines Verification System is now Live and connected to the European Hub.
Click here to read the press release
L’agence fédérale des médicaments et des produits de santé a mis à jour son site web avec de nouvelles informations.
Cliquez ici pour la mise à jour.
Les nouvelles informations contiennent également une lettre circulaire