Medicinal products supplied to participants in a trial, used in accordance with the protocol, which do not fall under the definition of IMPs in Directive 2001/20/EC.
Medicinal products used to minimise anticipated adverse reactions e.g. corticosteroids and/or antihistamines (NIMP) treatment given to reduce the risk of expected adverse reactions before the administration of a new anti-neoplastic agent (IMP).
Medicinal products used as rescue medication e.g. opioid pain relief treatment (NIMP) given as a rescue medication when administration of a new IMP painkiller (IMP) is found not to give adequate pain relief
Medicinal products used as challenge agents e.g. a skin prick test (NIMP) used to identify participants with allergic responses for the inclusion/exclusion criteria for a clinical trial.
Medicines used to assess primary end-points in the clinical trial e.g. PET radiopharmaceuticals (NIMP) administered to a clinical trial population to measure organ function before and after the participant has been given an IMP whose effects in this organ are the primary end-point.
Concomitant medicinal products systematically prescribed to study participants e.g. Anti-cancer treatment (NIMP) in the trial of a new anti-sickness drug (IMP), where the objective of the trial is to assess the anti-sickness effect of the new drug by testing the new drug against the gold standard anti-sickness drug (NIMP) in participants treated with the same anti-cancer treatment (NIMP).
Background treatment administered to each participant in a trial e.g. Adjuvant chemotherapy (NIMP) given to all participants in the development of a new indication for a licensed medicine (IMP).
Detailed and useful examples of NIMPs can be found in the European Commission ‘Definition of Investigational Medicinal Products (IMPs). Definition of Non Investigational Medicinal Products’.