of key data and study rational for further evaluation For explanatory notes, please refer to GVP Module VII on PSURs section VII.B.5.15 and appendix 2. The LMS should comment on the signals classified by the MAH(s) as new, ongoing and closed during the reporting interval. The LMS should critically assess the evidence presented in support of MAH(s) conclusions on the safety signals. It should be made clear where the LMS does not agree with the outcome of the MAH’s signal evaluation and/or considers further actions are needed. The LMS should also consider whether other signals should have been evaluated by the MAH(s) (e.g. further to review of Eudravigilance data). Lead Member State assessment comment: Evaluation of risks and new information This sub-section should assess the critical appraisal provided by the MAH of new information relevant to previously recognised risks that is not already included in sub-section 2.2 (“Signal evaluation”). The aim is to provide new information (e.g. information arising from studies to further characterize an important potential risk) and not to present all the information related to the list of safety concerns. Where new risks are identified, there should be consideration of whether these might be classified as ‘important’ or ‘other’ risks and whether any action (e.g. update of product information) are warranted. Lead Member State assessment comment: Characterisation of risks This section should reflect a characterization of the important identified and/or potential risks for the product based on cumulative data (i.e. not solely based on information received during the
of key data and rational for further evaluation study For explanatory notes, please refer to GVP Module VII on PSURs section VII.B.5.15 and appendix 2. The LMS should comment on the signals classified by the MAH(s) as new, ongoing and closed during the reporting interval. The LMS should critically assess the evidence presented in support of MAH(s) conclusions on the safety signals. It should be made clear where the LMS does not agree with the outcome of the MAH’s signal evaluation and/or considers further actions are needed. The LMS should also consider whether other signals should have been evaluated by the MAH(s) (e.g. further to review of Eudravigilance data). Lead Member State assessment comment: Evaluation of risks and new information This sub-section should assess the critical appraisal provided by the MAH of new information relevant to previously recognised risks that is not already included in sub-section 2.2 (“Signal evaluation”). The aim is to provide new information (e.g. information arising from studies to further characterize an important potential risk) and not to present all the information related to the list of safety concerns. Where new risks are identified, there should be consideration of whether these might be classified as ‘important’ or ‘other’ risks and whether any action (e.g. update of product information) are warranted. Lead Member State assessment comment: Characterisation of risks This section should reflect a characterization of the important identified and/or potential risks for the product based on cumulative data (i.e. not solely based on information received during the
WC500199651.docx