European Commission and Directorate-General for Health and Food Safety 2 September 2025, COMMISSION STAFF WORKING DOCUMENT Summarising evidence supporting the legislative proposal laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicines of common interest and amending Regulation (EU) 2024/795
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European Union · · · 02-09-2025
Contents 1.Introduction 2.Background 2.1.Political and legal context of shortages of medicines 2.2.Relevant existing EU legislation and related initiatives 2.3.Critical medicines and other medicines of common interest 2.3.1.The EU pharmaceutical industry 2.3.2.Critical medicines: a diverse set of pharmaceuticals 2.3.3.Medicines of common interest 3.Problem definition 3.1.
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