Asset Publisher

null If the research report has been submitted to Fimea in conjunction with a marketing authorisation application, should a separate report on the research findings be submitted to clinical trials?

If the research report has been submitted to Fimea in conjunction with a marketing authorisation application, should a separate report on the research findings be submitted to clinical trials?

Yes. Finding and identifying a report concerning a Finnish research project is difficult as the volume of marketing authorisation applications processed by Fimea is so high.

 

10 Nov 2015