Any noxious and unintended response to an unapproved medicinal product, related to any dose. The phrase “response to an unapproved medicinal product” means that a causal relationship between the product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out. (‘Unapproved medicinal product’ here includes approved products used at levels or in ways that are unapproved)
A noxious and unintended response to a drug that occurs at doses of marketed medical products normally used in humans for prophylaxis, diagnosis or therapy of diseases or for modification of physiological function.