Launching drugs in Europe requires navigating complex regulatory pathways across 27 member states, each with distinct rules, languages, and local authorities. Four main routes exist—centralized, decentralized, mutual recognition, and national—chosen based on product type, launch strategy, and market goals. Success depends on managing requirements like local representation, national codes, blue box labeling, serialization, and compliance with the EU Falsified Medicines Directive. Additional steps include notifying competent authorities of launch dates, ensuring promotional material compliance, and securing distribution licenses. IQVIA’s expertise helps companies streamline planning, minimize delays, and achieve faster, compliant market entry.

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