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Which products qualify for Central Authorisation in the EU/EEA?

  • Products derived from biotechnology

  • Orphan medicinal products

  • Medicinal products for human use which contain an active substance authorised in the Union after 20 May 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorders or diabetes.

  • All medicinal products that contain an active substance not authorised before 20 May 2004, or constitute a significant therapeutic scientific or technical innovation, or for which an EU authorisation would be in the interest of patients.