Guideline on good pharmacovigilance practices (GVP) – Module VI (Rev 2)
TABLE OF CONTENTS
VI.A. Introduction ....................................................................................... 6
VI.A.1. Terminology .................................................................................................... 6
VI.A.1.1. Adverse reaction, causality ............................................................................. 6
VI.A.1.2. Overdose, off-label use, misuse, abuse, occupational exposure, medication error,
falsified medicinal product ............................................................................................ 7
VI.A.1.3. Active substance, excipient, medicinal product .................................................. 7
VI.A.1.4. Primary source, healthcare professional, consumer ............................................ 8
VI.A.1.5. Medical confirmation ...................................................................................... 8
VI.A.1.6. Seriousness .................................................................................................. 9
VI.A.1.7. Individual case safety report (ICSR) ................................................................ 9
VI.A.1.8 nullFlavors ..................................................................................................... 9
VI.B. Structures and processes.................................................................. 11
VI.B.1. Collection of individual safety reports................................................................ 11
VI.B.1.1. Unsolicited reports ....................................................................................... 11
VI.B.1.1.1. Spontaneous reports ................................................................................. 11
VI.B.1.1.2. Literature reports ..................................................................................... 12
VI.B.1.1.3. Reports from non-medical sources .............................................................. 13
VI.B.1.1.4. Information on suspected adverse reactions from the internet or digital media . 13
VI.B.1.2. Solicited reports .......................................................................................... 13
VI.B.2. Validation of reports ....................................................................................... 14
VI.B.3. Follow-up of reports ....................................................................................... 16
VI.B.4. Data management ......................................................................................... 17
VI.B.5. Quality management ...................................................................................... 18
VI.B.6. Special situations ........................................................................................... 18
VI.B.6.1. Use of a medicinal product during pregnancy or breastfeeding .......................... 18
VI.B.6.2. Use of a medicinal product in a paediatric or elderly population ......................... 20
VI.B.6.3. Reports of overdose, abuse, misuse, medication error or occupational exposure . 20
VI.B.6.4. Lack of therapeutic efficacy .......................................................................... 20
VI.B.7. Submission of individual case safety reports (ICSRs) .......................................... 21
VI.B.7.1. Submission time frames of ICSRs .................................................................. 22
VI.B.7.2. Report nullification ...................................................................................... 22
VI.B.7.3. Report amendment ...................................................................................... 22
VI.B.8. Modalities for submission of individual case safety reports (ICSRs) ....................... 22
VI.C. Operation of the EU network ............................................................. 24
VI.C.1. Management of individual safety reports for clinical trials, post-authorisation studies,
compassionate use and named patient use in the EU ..................................................... 25
VI.C.1.1. Management of individual safety reports for clinical trials ................................. 26
VI.C.1.2. Management of individual safety reports for non-interventional post-authorisation
studies, compassionate use and named patient use....................................................... 27
VI.C.1.2.1. Non-interventional post-authorisation studies .............................................. 28
VI.C.1.2.1.1. Non-interventional post-authorisation studies with a design based on primary
data collection .......................................................................................................... 29
VI.C.1.2.1.2. Non-interventional post-authorisation studies with a design based on
secondary use of data ............................................................................................... 30
VI.C.1.2.2. Compassionate use and named patient use .................................................. 30