A report on the research findings must be submitted to Fimea within one year of the project concluding. Should the report follow the same format as the research report submitted as part of a marketing authorisation application?
No. A summary, synopsis, offprint or abstract is sufficient. A complete research report shoul dbe submitted only upon request by Fimea. If the research subjects include persons undder the age of 18 or the sponsor is the investigational medicinal product marketing authorisation holder, the report must be submitted within six months.