WEBINAR VIDEO | The New EU Deforestation Regulation: Stay Compliant, Succeed Sustainably
In this Life Sciences session, the experts from our agri-food law team Philippe de Jong and Bart Junior Bollen provided valuable insights into the Regulation’s implications and equiped businesses with the necessary knowledge to ensure compliance in this evolving landscape. you
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EU General Court bars patient association from challenging medicine authorisation refusal
In Case T‑278/25, the EU General Court recently dismissed as inadmissible a challenge brought by a patient advocacy association against the European Commission’s refusal to renew the conditional marketing authorisation for a treatment against Duchenne muscular dystrophy (DMD). The case is significant because it adds to the case law on contesting Commission decisions relating to the marketing of medicinal products. In this blog post, we look at how the Court came to the conclusion that the association lacked standing to litigate and use this as a basis for an informal categorisation of the existing case law.
Read onDespite EU harmonisation, Member States may impose authorisation requirements on pharmacy-prepared medicines, rules EU Court of Justice
Under EU pharmaceutical law, certain medicines fall outside the scope of Directive 2001/83/EC (i.e. the Community code on medicinal products for human use). This includes “magistral formulae” (prepared in a pharmacy for an individual patient on prescription) and “officinal formulae” (prepared in a pharmacy in accordance with a pharmacopoeia and supplied directly to that pharmacy’s […]
Read onEU General Court: technical vaccine data does not have to be disclosed on request
The EU General Court delivered a significant judgment concerning access to documents held by the European Medicines Agency (EMA), this time relating to a conditionally authorised COVID-19 vaccine. This case (T-623/22) serves as an addition to the elaborate case law on the balance between transparency in health matters and the protection of companies' commercial interests. On this (rare) occasion, the commercial interests of the conditional marketing authorisation (‘MA’) holder prevailed, although an appeal is currently pending (C-38/26 P).
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