Submission of applications

All information on the technical requirements for the submission of applications* for clinical trials for medicinal products is described here:

* These include:

  • Clinical trials with medicinal products
  • Clinical trials with ATMP (Advanced Therapy Medicinal Products, such as transplant products, gene therapeutics, somatic cell therapeutics, products with genetically modified organisms, among others)
  • Complex clinical trials
  • Applications for a temporary authorisation for the use of medicinal products in accordance with Article 9b paragraph 1 TPA
  • As well as all submissions during the conduct of the trials such as
    • Changes
    • Notifications
    • Reports including suspected unexpected serious adverse reaction (SUSAR)

Last modification 03.05.2022

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