NLClinicalTrialsIMP object

Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)

Arzneimittelgesetz AMG: applicable for clinical trials on medicinal products and ATMP; transposition of Directives 2001/20/EC and 2005/28/EC into national law.

Transposition of (GCP) Directive 2005/28/EC

Incorporated in transposition act(s) of Directive 2001/20/EC

Act transposing (GCP) Directive 2005/28/EC

Arzneimittelgesetz AMG

Other applicable regulations/ implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

-Krankenanstalten- und Kuranstaltengesetz §8c KAKuG-Hospital Act.
-Datenschutzgesetz 2000 (DSG2000)- Data Protection Act: Federal Act concerning the Protection of Data (English version available)
-Ärztegesetz: code of conduct for physicians