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.

Labeling and packaging of medicinal products for human use: guidelines updated

The holders of a marketing authorization for a medicinal product for human use must follow certain guidelines for labeling and packaging. These guidelines have now been updated.

The guidelines “Labeling of medicinal products” to be applied in the context of a new marketing authorization (MA), a renewal or a variation of a medicinal product for human use have been updated. The guidelines are thus adapted to European directives and other national or international agreements.

The main changes concern:

  • sections 16, 17, 18 and 19 of the packaging text according to the QRD template;
  • definition of small packages;
  • definition and submission of mock-ups;
  • use of trademarks, symbols ® and TM or mention “brand of”;
  • use of logos and use of QR codes;
  • labeling of combination packages and labeling of homeopathic medicines.