IMPStudy object

IMP - Definition available in national law

Yes

IMP - Definition

"Prüfpräparat" (according to Art 2a (14) AMG): The pharmaceutical form of a drug or placebo tested in a clinical trial or used as comparator; further any approved human medicine if applied in a form different from marketed approval or in a different therapeutic indication or if used to acquire additional information for the approved form.

IMP Study - Definition available in national law

Yes

IMP Study - Definition

"Klinische Prüfung": see Art 2a (1) AMG

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