Article 2
Unless other requirements have been laid down as a condition of granting the marketing authorization by the Community, suspected unexpected adverse reactions which are not serious shall be reported by the holder of the marketing authorization in a distinct and clearly identified section of the periodical reports referred to in Articles 22 (2) and 44 (2) of Regulation (EEC) No 2309/93 ('safety updates'). These safety updates shall consist of a line listing of individual case reports accompanied by an overall scientific evaluation including a narrative review of the nature and other relevant characteristics of reactions, with special attention to any change in frequency.