European Union: Food and Drugs Law

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Article
Playing Loose – CJEU Asked To Decide On Combination SPCs
The EU Court of Justice faces a pivotal decision on whether medicines approved as monotherapy but labeled for use in combination with other drugs qualify for Supplementary Protection Certificate (SPC) protection as combinations of active ingredients. This referral, stemming from Genmab's attempts to secure SPC protection for loose combinations including daratumumab, could resolve over a decade of legal uncertainty and fundamentally reshape how pharmaceutical companies approach regulatory strategy for combin
Denmark IP
HL
HGF Ltd
Article
The End Of Animal Testing? The EU’s Chemical Safety Plan Explained
The European Commission has published a comprehensive roadmap to phase out animal testing for chemical safety assessments by 2026, outlining 22 concrete actions across 15 legislative domains. While the communication itself is non-binding, it signals significant regulatory changes ahead that will reshape data requirements, testing strategies, and compliance obligations for businesses operating in pharmaceuticals, chemicals, and related sectors.
European Union Government
SR
McDermott Will & Schulte
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