IMPStudy object

IMP - Definition available in national law


IMP - Definition

'A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorisation but used or assembled (specially formulated or packaged) in a way different from the authorised form, or when used for an unauthorised indication, or when used to gain further information about the authorized form' (Art 2 Regulation no 433/2004)

IMP Study - Definition available in national law


IMP Study - Definition

'A clinical pharmaceutical study: A systematic testing of a medicine with the purpose of finding or confirming its effects and/or finding the side effects of the medicine and/or absorption, circulation, metabolism and the excretion of the drug with the purpose of checking its security and functionality.' (Art 2 Regulation no 433/2004)

Additional Information

Non-interventional study (definition pursuant to to Art 2 Regulation no 433/2004):
'A study where the medicinal product or products are prescribed in a normal manner in accordance with the terms of its marketing authorisation. Treatment of the patient is not pre-determined by a clinical trial protocol, but rather follows current practice. The instructions concerning the medicinal product are clearly separated from the decision that the patient shall take part in the trial. No supplementary analyses or supervision shall be carried out in treating the patient and epidemiological methods used in analysing the data collected.'