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Centralised Procedure

Meaning

The Centralised Procedure refers to a mandatory regulatory pathway for the authorization of medicinal products across all member states of the European Union (EU), culminating in a single marketing authorization valid throughout the entire EU territory. This critical process ensures a unified, high-standard assessment of the safety, efficacy, and quality of new and innovative therapies, including many advanced hormonal agents and complex peptide treatments. It serves as a vital mechanism for facilitating patient access to new medications while maintaining stringent pharmaceutical standards. This regulatory route is essential for ensuring clinical consistency across a broad European patient population.