DefinitionInNationalLaw object

1) Non-interventional post-marketing clinical trial (pharmacoepidemiological testing) is a trial that implies the medicinal product application in respect to the conditions prescribed in the marketing authorisation and where the election of the patient is not predetermined by the clinical trial protocol but is a part of a ongoing practice of the usual type of treatment; in addition, the medicinal product prescription is clearly separated from the decision to involve the patient into the trial. Additional diagnostic procedures or the monitoring procedures are not applied, and the epidemiological methods are used to analyze the derived data;