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Advanced Therapy Medicinal Products (ATMP)

General overview of Advanced Therapy Medicinal Products, transplants and procedures  

Legal texts

Laws, ordinances

Teilrevision der Heilmittel-Gebührenverordnung vom 15. März 2007

Internationale Guidelines

Working documents/forms /instructions /information sheets

Instructions /information sheets

Authorization Holder

Documents and Forms

  • 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 

Further information

Federal Office of Public Health

European Medicines Agency (EMA)

PIC/S - Pharmaceutical Inspection Convention / Pharmaceutical Inspection Cooperation Scheme

WHO - The World Health Organisation

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