SCHEDULES

F1SCHEDULE 12AFurther provision as to the performance of pharmacovigilance activities

Annotations:
Amendments (Textual)

PART 8Periodic safety update reports

Format of periodic safety update reports27

1

Electronic PSURs must be submitted in the following format—

a

Part I: title page including signature;

b

Part II: executive summary; and

c

Part III: table of contents which contains—

i

introduction,

ii

worldwide marketing authorisation status,

iii

actions taken in the reporting interval for safety reasons,

iv

changes to reference safety information,

v

estimated exposure and use patterns—

aa

cumulative subject exposure in clinical trials,

bb

cumulative and interval patient exposure from marketing experience,

vi

data in summary tabulations—

aa

reference information,

bb

cumulative summary tabulations of serious adverse events in clinical trials,

cc

cumulative and interval summary tabulations from post-marketing data sources,

vii

summaries of significant findings from clinical trials during the reporting interval—

aa

completed clinical trials,

bb

ongoing clinical trials,

cc

long-term follow-up,

dd

other therapeutic use of medicinal product,

ee

new safety data related to fixed combination therapies,

viii

findings from non-interventional studies,

ix

information from other clinical trials and sources,

x

non-clinical data,

xi

literature,

xii

other periodic reports,

xiii

lack of efficacy in controlled clinical trials,

xiv

late-breaking information,

xv

overview on signals: new, ongoing or closed,

xvi

signal and risk evaluation—

aa

summaries of safety concerns,

bb

signal evaluation,

cc

evaluation of risks and new information,

dd

characterisation of risks, and

ee

effectiveness of risk minimisation (if applicable),

xvii

benefit evaluation—

aa

important baseline efficacy and effectiveness information,

bb

newly identified information on efficacy and effectiveness, and

cc

characterisation of benefits,

xviii

integrated benefit-risk analysis for authorised indications—

aa

benefit-risk context: medical need and important alternatives, and

bb

benefit-risk analysis evaluation,

xix

conclusions and actions, and

xx

appendices to the PSUR.

2

In this paragraph, “signal evaluation” means the process of further evaluating a validated signal taking into account all available evidence, to determine whether there are new risks causally associated with the active substance or medicinal product, or whether known risks have changed, and that process—

a

may include non-clinical and clinical data; and

b

must be as comprehensive as possible regarding the sources of information used for that process.