definiens: shall mean Adverse Drug Reaction . In the pre - approval clinical experience with a new medicinal product or itsnew usages, particularly as the therapeutic usages, particularly as the therapeutic dose(s ) may not be established : allnoxious and unintended responses to a medicinal product related to any dose should be considered adverse drugreactions . For authorised products, adverse drug reactions, as established by regional regulations, guidance, and practices, concern noxious and unintended responses to a medicinal product . All adverse reactions, in contrast to an adverse event, are characterized by the fact that a causal relationship between the medicinal product and the occurrence is at leastsuspected . Adverse reactions also include clinical consequences associated with the use of the product outside the termsof the SPC . For regulatory reporting purposes, if an event is spontaneously reported, even if the relationship is unknownor unstated, it meets the definition of an adverse drug reaction