NLClinicalTrialsIMP object

Applicable national regulations

Transposition of (CT) Directive 2001/20/EC
Transposition of (GCP) Directive 2005/28/EC
Other

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

Medicinal Products Act (Arzneimittelgesetz AMG): (see also: unofficial English translation)

Transposition of (GCP) Directive 2005/28/EC

Available as separate legal text

Act transposing (GCP) Directive 2005/28/EC

GCP-Ordinance - GCP-V (GCP Verordnung)- currently only in German

Additional Information

In particular, sections 40-42a AMG in connection with the GCP ordinance are relevant for the conduct of a clinical trial.

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
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