Belgium: Food and Drugs Law

In our fifth alert in this EU Pharma Package Series, we provided an analysis of the background and ongoing legal debates regarding the concept of the global marketing authorization (GMA).

Addressing antimicrobial resistance (AMR) is one of the key objectives of the EU’s legislative reform. However, the development pipeline for new effective antimicrobials is obstructed, primarily due to a profound market failure: the low commercial value of the antimicrobial medicinal product market (costly development versus naturally limited market). In short, the market alone cannot deliver the solutions urgently needed to address AMR.

With formal adoption by both the Council of the EU and the EU Parliament expected by summer 2026, stakeholders should start looking into implementation preparations...

In our first alert in this weekly series on the EU Pharma Package we provided some important background and general information about the status of the Pharma Package and how the trilogues work...

Although the European Commission, European Parliament and the Council of the European Union all agree on reducing the baseline protection period, the three institutions differ as regards the modulation system for extensions to the baseline period.

Stakeholder input will influence guidelines for AI Act implementation in healthcare and medical technologies

On 21 September 2023, the EU Court of Justice (‘CJEU') handed down its ruling in the Apotheke B. case (C-47/22), and it is a good example of the high threshold set by the EU Court of Justice...

During this webinar, Kirian Claeyé and Bart Junior Bollen guide you through the eagerly anticipated reform of the reimbursement procedures for medicines in Belgium.

Despite the delay in implementing marketing and advertising restrictions for products high in fat, salt or sugar (HFSS), there have been some important developments in relation to HFSS.