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.

Safer Europe Without Falsified Medicines – Talinn conference November 8-9, 2017

Safer Europe Without Falsified Medicines Conference will be held during the period of the Estonian Presidency of the EU Council and supports Estonia’s priorities as the ICT projects leader in Europe.

The aim of the Conference:

  • To understand the current state of implementation of the safety features of medicinal products at the European Union level and in Member States
  • To identify the challenges for stakeholders and governments in implementing the safety features of medicinal products
  • To develop ideas for coping with challenges

read more

 

Registration for Marketing Authorisation Holders – Wave 2 open

The Wave 2 registration to the Belgian Medicines Verification System for Marketing Authorisation Holders is open.
MAHs who register before end December 2017 will benefit from a 25% discount on the registration fee if the payment of the fee is received latest by end January 2018. We invite the MAH’s who desire to register to do so as soon as possible.

Please consult the MAH Registration section on this website for more information on the procedure and download the appropriate documents.

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