DefinitionInNationalLaw object

Clinical study with intervention: any investigation which includes a change, influence or programming of health care, behavior or knowledge of the participants or caregivers, in order to discover or verify the health effects, including exposure to drugs, the use of medical devices, performing surgical techniques, exposure to radiation, the application of cosmetics and body care, physiotherapy intervention, the intervention of psychotherapy, the use of transfusion, cell therapy, participation in education sessions individually or in groups, the intervention diet, the intervention organization or access health care or therapeutic intervention designated as unconventional;
Directive 2001/20/EC applies to medicinal products which are specifically addressed in the EU law on pharmaceuticals.