WEBINAR VIDEO | Navigating Mergers and Acquisitions in Life Sciences: Insights for Success and Pitfalls to avoid
During this webinar, the experts from our assembled transactions team, Richard Liu, Mieke D’hanis and Pauline Geentjens, provide valuable insights, inform you of common pitfalls and let you in on a number of tips and tricks during an M&A process.
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New EU sample retention rules coming up for veterinary medicines repackaged for parallel trade
The Veterinary Medicinal Products Regulation (EU) 2019/6 has applied in the EU since 28 January 2022, replacing Directive 2001/82/EC. The new rules on good manufacturing practice (GMP) will in turn be fleshed out by Commission Implementing Regulation (EU) 2025/2091, which will apply from 16 July 2026. In addition, the European Commission is introducing new GMP requirements concerning the retention of samples for veterinary medicinal products that are repackaged for parallel trade. This blog post briefly examines what these new obligations entail.
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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.
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Despite 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 […]
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