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Elisabet Cots

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In EU Pharmaceutical Package

EU Pharma Package: When Will the New Rules Apply?

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On 17 September 2026, the Council published its first-reading positions on the proposed EU Pharmaceutical Regulation and Directive. The texts largely preserve the compromise reached in December 2025 described in our earlier alert, and provide the clearest indication yet of the framework that will soon be adopted. Last steps of the legislative procedure  The legislative process is now at a very advanced stage. Although there is no official information on timings, it is expected that…

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In Medical Devices

Spanish Judgment May Shorten Price and Reimbursement Procedures for Medicines

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In brief On 26 June 2023, the Spanish National Court annulled the evaluation system of newly approved medicinal products based on Therapeutic Positioning Reports (“ITPs”) set up by the Spanish Ministry of Health in 2020 (“Plan”). The Court based its decision on the grounds that (1) the system was created without following the legal procedure, and (2) was approved by a body that did not have the authority to do so. The Court concludes that…

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