Medicinal Product (Definition provided in part 1, section 2 of the Danish Medicines Act).
Health Research Project/ Clinical trial of Medicines (Definition according to part 2, section 2(1) of the Committee Act):
„Any trial on humans with the aim of uncovering or verifying the clinical, pharmacological or other pharmacodynamic effect of one or several trial medicines or to identify adverse reactions to one or several trial medicines or to investigate absorption, distribution, metabolism or excretion of one or several trial medicines with a view to assessing their effect or safety.“
• The MP(s) in the trial are prescribed in the usual manner in accordance with the terms of the marketing authorization
• The decision to prescribe the medicine concerned is clearly separated from the decision to include a specific patient in the trial
• The actual treatment follows normal practice and is not decided by a trial protocol
• No additional diagnostic or control procedures are carried out (in Denmark, questionnaires are not considered to be additional procedures)
• Epidemiological methods are used for the analysis of the gathered data.