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Medicinal Products Act (Arzneimittelgesetz – AMG)
Germany_AMG_English.pdf

AMG Fee Regulation (AMGKostV)
Germany_AMGKostV_English.pdf

GCP Ordinance (GCP-V)
Germany_GCP-V_English.pdf

Application Form Module 1
Germany_Module 1_English.pdf

Application Form Module 2
Germany_Module 2_English.pdf

Joint Pilot Project in accordance with Regulation (EU) No. 5362014 under consideration of the AMG and GCP-V
Germany_Regulation (EU) No. 536_2014 incl AMG and GCP-V_Guideline joint project NCA and ECs.pdf

Regulatory and Start-up Guideline
Regulatory and Start-up Guideline Clinical Trials Germany_final_2019.pdf