Definition according to GVP Annex I (Rev 3):
An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this association has not been confirmed.
Explanatory wording provided in GVP module V (Rev 2):
Undesirable clinical outcomes for which there is scientific evidence to suspect the possibility of a causal relationship with the medicinal product, but where there is currently insufficient evidence to conclude that this association is causal.
