Adverse Drug Reaction (ADR)

Adverse Drug Reaction (ADR)

In the pre-approval clinical experience with a new medicinal product or its new usages,

particularly as the therapeutic dose(s) may not be established: all noxious and unintended

responses to a medicinal product related to any dose should be considered adverse drug

reactions. The phrase responses to a medicinal product means that a causal relationship between

a medicinal product and an adverse event is at least a reasonable possibility, i.e. the relationship

cannot be ruled out.

Regarding marketed medicinal products: a response to a drug which is noxious and unintended

and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of

diseases or for modification of physiological function

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