Belgium: Food and Drugs Law

Belgium's federal Chamber of Representatives has adopted a comprehensive bill introducing significant changes to pharmaceutical reimbursement procedures, including simplified approval tracks, new combination therapy rules, and an 80 million EUR annual industry contribution. The legislation also addresses drug unavailability issues and postpones certain 2024 reforms until 2028, fundamentally reshaping the financial and operational landscape for pharmaceutical companies operating in Belgium.

The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations ("MA") for medicinal products) ("Variations Guidelines").

The drug agency's new guidance focuses on regulatory authorities but holds relevance for the industry...