2D matrix code

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”

New legislation

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:

MB-BS-OT-OA

MB-BS-OT-INAMI

MB-BS-Intervention-tegemoetkoming

 

DETAILED FMD SCOPE FOR BELGIUM

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))

  1. a) All products on prescription
  2. b) Reimbursable products that are bearing a Unique Bar Code (UBC) today
  3. c) Products on annex II of the D.R. (black list)
  4. 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.

FAGG

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.

omzendbrief

 

 

Loading specifications

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.