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).

On 27 July 2015, the Minister for Social Affairs and Public Health, Maggie De Block ("the Minister"), and the pharmaceutical sector umbrella organisations pharma.be and FeBelGen entered into a "Pact for the Future"...

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 Judgment of the Brussels Court of Appeal is the latest development in the saga in Belgium where a Belgian parallel importer, PI Pharma NV, imported a generic Sandoz product from the Netherlands...

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

The EU legal and policy framework regarding critical medicines and medicine shortages is rapidly changing. In the past 12 months alone, there have been numerous developments...

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.

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars.

May a dominant pharmaceutical company refuse to supply in full the orders it receives from a wholesaler in an EU country in order to limit parallel trade in its products in the European Union?

On 11 December 2025, following overnight negotiations, the Council and the European Parliament announced a political agreement on the long-awaited Pharma Package (see here).

Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes...

On 25 September 2023, one year after the publication of the proposal, the European Commission adopted the restriction of intentionally added microplastics under the European Union Registration...

On 27 April 2017, the President of the Dutch-language Commercial Court of Brussels decided a case concerning the repackaging of parallel imported pharmaceuticals, in which it applied the so-called...

FAQ explains research exemption, dual conformity assessment and clinical data obligations for devices and diagnostics

The Belgian Competition Authority ("BCA") imposed a fine of EUR 2.78 million on Novartis for disparaging its competitor's products. Following a press release in January, the full decision...

The Food Standards and Information Focus Group (FSIFG) has prepared draft guidance on how plant-based dairy companies should describe their products...

A novel form of 'named patient use' mechanism is meant to address special pharma needs and drug shortages

In a judgment of December 23, 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024

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.

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