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

 

 

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.

Joint Declaration Riziv/Inami – Fagg/Afmps – BeMVO

                                                   

Riziv/Inami and Fagg/Afmps have emitted together with BeMVO a joint declaration confirming and specifying various elements related to the implementation of FMD in Belgium.

The different aspects addressed concern amongst others the starting date, the FMD scope for Belgium , the alignment with Grand Duché du Luxembourg, Instructions for package design and submission of variations, major milestones of the implementation, …

agreement fagg_riziv_bemvo

Annex1-ScopeMatrix

Annex2-PackageDesign