DefinitionInNationalLaw object

Definition in national law

No official definition found.
Legal definition exists in the German Medicinal Product Act §67 for studies with drugs: (6) The pharmaceutical entrepreneur shall immediately give notice to the Federal Panel Doctors' Association, the Central Federal Association of the health insurance funds, as well as the competent higher federal authority of tests which serve the purpose of gathering knowledge on the application of authorized or registered medicinal products. In this regard, the location, time, purpose and observation plan of the non-interventional study shall be stated and the names of the participating doctors revealed to the Federal Panel Doctors' Association and the Central Federal Association of the health insurance funds. Further, definitions exist in other documents but are not legally binding.

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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