IMPStudy object

Investigational Medicinal Product (pursuant to Art Rulebook Application 2011):
'is the pharmaceutical form of the active substance being tested, or the placebo used for comparison with the tested substance, as well as the medicine with an authorization for placement on the market of its form or packaging is changed, and/or if it is used in a way different to the approved method of use as per the authorization for placing the medicine on the market, when the medicine is tested for application for new indications and when the medicine is used to provide new information on its approved use'

Definition of a MP and the various types (e.g. ATMP) are specified in Art 14-24 Law on MP & MD 2010

Clinical trial (pursuant to Art 59 Law on MP 6 MD 2010):
'a medicinal product examination performed on humans there to be determined or confirmed clinical, pharmacological or pharmacodynamic effects of one or more investigational medicinal products, and/or to be identified any adverse reactions to one or more investigational medicinal products, and to be examined the absorption, distribution, metabolism and excretion of one or more medicinal products, in order their safety and efficacy to be determined'

Interventional post-marketing clinical trial (pursuant to Art Law on MP & MD 2010):
'a trial that implies the medicinal product application in respect to the conditions prescribed in the marketing authorisation, and that requires additional diagnostic procedures, as well as the monitoring procedures defined by the clinical trial protocol'

Non-interventional post-marketing clinical trial (pharmacoepidemiological testing) (pursuant to Art 2 Law on MP & MD 2010):
'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'