The list of required data and documents submitted (in line with SÚKL on-line form):
- Name/business name and address of the marketing authorization holder
- Identification of the study product, a code that is assigned to the product by SÚKL
- Title of the study (and ID number of study assigned by MAH)
- Date of start of data collection, expected date of end of data collection, expected date of data analysis end and expected date of the final report submission
- Study protocol submission via online form