CATimelineAuthorisation object

General timespan (max nr days)

60 (IMP Type A+B) or 30 (IMP Type C)

Mode of approval (General)

Explicit (IMP Type A) or Tacit (IMP Type B+C)

ATMP/GMO trials (max nr days)

90

Mode of approval (ATMP/GMO trials)

Explicit

External expert advice required (max nr days)

180

Applicable national legal framework/ Reference

Section 55 Act on Pharmaceuticals

Additional Information

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 authorisation

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
Feedback