February 2022: Hungary Update

OGEYI, Hungary, specified the requirements in English for the documents to be submitted with Part I and II  application for clinical trial authorization on February 23, 2022.

Requirements to be entered into Clinical Trial Information System (CTIS) in Part I and II are elaborated for following sections:

  • Annex I
  • Cover Letter
  • Protocol
  • Labelling of Investigational Medicinal Product
  • Subject Information and Informed Consent
  • Suitability of Investigator
  • Suitability of Facilities

Additionally, templates for investigator CV and site suitability have also been uploaded on the website.

More information can be found here.