CALanguageOfSubmission object
Language(s) of application
Official national language
Portuguese
English
English accepted
Partly, not for all documents
For official application documents and scientific documents only
Documents mandatory to be in official national language
Cover letter
Protocol Summary
Information material, Documents and Forms intended for study participants and patient information
Documents mandatory to be in official national language: Cover Letter; Synopsis of the Protocol; Informed consent; MD label; Patient card; Any applicable scales