Advanced Therapy Medicinal Products (ATMP)

General overview of Advanced Therapy Medicinal Products, transplants and procedures  


Legal texts

Working documents/forms /instructions /information sheets

  • Authorisations TpP/GT/GMO
  • Establishment licence TpP/GT/GVO
  • GMP and GDP certificates
  • Special licence for non-authorised TpP/GT/GVO
  • Clinical trials TpP/GT/GMO
  • Biovigilance TpP/GT/GMO
  • Autologous transplants
  • Approval of procedures