CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Competent Authority/-ies (CA)
Ethics committee(s)

CA - Submission for authorisation mandatory for

Clinical IMP trials

CA - Submission required to

National CA

Additional Information

There are various types of Application:
Types of IMP obtained by biotechnology or containing substances of human or animal origin:
Type A: IMP is NOT authorised in the Czech Republic or in other EU Member States.
Type B: IMP is authorised in the Czech Republic or in other EU Member States, but not used in accordance with the terms of marketing authorization
Type C: IMP is authorised in the Czech Republic and used in accordance with the terms of marketing authorization
Accordingly, the approval mode (silent or explicit approval) and timelines may differ (further information available on SUKL website in section: Medicines > Clinical trial on pharmaceuticals > Details of clinical trials > Guidelines and Forms > KLH-20 version 5.)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395