definiens: means, with respect to a Product, ( a ) any report, including from any individual case safety reports from clinicaltrials / studies ( including interventional investigator initiated trials ), of a suspected adverse drug reaction which may arise from the use withinthe terms of the marketing authorisation or outside the terms of the marketing authorisation, including overdose, off - label use, misuse, abuseand medication errors, occupational exposure or complaints regarding Product quality or falsified Product, ( b ) any report of the followingevents or patterns of use, even those which do not result in an adverse drug reaction : intentional or accidental overdose, misuse, abuse, off - label use, medication errors, occupational exposure, failure of expected pharmacological action ( lack of therapeutic efficacy ), exposureduring pregnancy or breast feeding, suspected transmission via a medicinal product of an infectious agent, or unintended therapeutic benefit, or ( c ) any information which does not fall within the definition of an individual case safety report but may, however, need to be collected for theinterpretation of safety data or for the benefit risk evaluation of the Products