ECLanguageOfSubmission object
Language(s) of application
Hungarian
English accepted
Full protocol, product information
Documents mandatory to be in official national language
Application letter, agreements concerning the Hungarian arrangement of the investigation (Declaration of Authorization, etc.), protocol summary/synopsis, patient information brochure, informed consent, product label/packaging, IFU (Instructions for Use)
Additional Information
NB!
Submission only via HRTC. There is no possibility of direct submisson to the EC!
