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 scope for FMD in Belgium is defined as:
For products referred to in art. 54(o) of Directive 2001/83/EC, ie, medicinal products other than radiopharmaceuticals (referred to in art. 54a(1))
- a) All products on prescription
- b) Reimbursable products that are bearing a Unique Bar Code (UBC) today
- c) Products on annex II of the D.R. (black list)
- d) With the exclusion of any product from a) or b) that appears on annex I of the D.R. (white list)
Further clarification on b):
Not all reimbursable products are requested to have a UBC today.
– Analgesics that are reimbursed for Chronicle Pain do not have a UBC and are not in scope for FMD
– Contraceptives that are not reimbursed but for which there is a specific compensation for women under the age of 21, have no UBC and are not in scope
(Note: contraceptives with the ‘standard’ Cx reimbursement are in scope)
– Chapter III medicines: more precisely, perfusions delivered through the public pharmacy have a UBC today, but will no longer need to have a UBC in the future and will not be in scope
Laxatives and calcium supplements (associated or not with vitamin D), that need to be registered by the pharmacist, do not have a UBC and are also not in scope.
The Belgian Medicines Verification System is now Live and connected to the European Hub.
Click here to read the press release
The national medicines agency in Belgium (FAGG/AFMPS) has updated his website with a set of new information elements.
You can access the FMD page on the website here
The new information contains also a document that has been emitted by the agency.
The specifications for MAHs regarding the product & pack data to be uploaded on the Belgian repository, covering Belgium and Luxembourg, have been updated. The load of the national code is NO longer mandatory.
Please find hereby the reviewed specifications.