Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2):
Introduction:
VI.A.1.1.
Adverse reaction, causality
VI.A.1.3.
Active substance, excipient, medicinal product
VI.A.1.4.
Primary source, healthcare professional, consumer
VI.A.1.5.
Medical confirmation
VI.A.1.7.
Individual case safety report (ICSR)
VI.B.
Structures and processes
VI.B.1.
Collection of individual safety reports
VI.B.1.1.1.
Spontaneous reports
VI.B.1.1.2.
Literature reports
VI.B.1.1.3.
Reports from non-medical sources
VI.B.1.1.4.
Information on suspected adverse reactions from the internet or digital media.
VI.B.6.1.
Use of a medicinal product during pregnancy or breastfeeding
VI.B.6.2.
Use of a medicinal product in a paediatric or elderly population
VI.B.6.3.
Reports of overdose, abuse, misuse, medication error or occupational
exposure
VI.B.6.4.
Lack of therapeutic efficacy
VI.B.7.
Submission of individual case safety reports (ICSRs)
VI.B.7.1.
Submission time frames of ICSRs
VI.B.7.2.
Report nullification
VI.B.8.
Modalities for submission of individual case safety reports (ICSRs)
VI.C.
Operation of the EU network
VI.C.1.1.
Management of individual safety reports for clinical trials
VI.C.1.2.1.
Non-interventional post-authorisation studies
VI.C.1.2.2.
Compassionate use and named patient use
VI.C.2.
Collection of individual safety reports
VI.C.2.1.
Responsibilities of Member States
VI.C.2.2.
Responsibilities of the marketing authorisation holder in the EU
VI.C.2.2.1.
Spontaneous reports
VI.C.2.2.3.
Case reports published in the medical literature
VI.C.2.2.3.1
Monitoring of the medical literature by the European Medicines Agency
VI.C.2.2.3.2
Exclusion criteria for the submission of ICSRs published in the medical
literature
VI.C.2.2.4.
Suspected adverse reactions related to quality defect or falsified medicinal
products
VI.C.2.2.5.
Suspected transmission via a medicinal product of an infectious agent
VI.C.2.2.6.
Emerging safety issues
VI.C.2.2.8.
Period after suspension, revocation or withdrawal of marketing authorisation
VI.C.2.2.9.
Period during a public health emergency
VI.C.2.2.10.
Reports from class action lawsuits
VI.C.2.2.11.
Reports from patient support programmes and market research programmes
VI.C.2.2.12.
Reporting of off-label use
VI.C.3.
Submission time frames of ICSRs in EU
VI.C.4.
Submission modalities of ICSRs in EU
VI.C.6.
Electronic exchange of safety information in the EU
VI.C.6.1.
Applicable guidelines, definitions, international formats, standards and
terminologies
VI.C.6.2.
Electronic submission of individual case safety reports
VI.C.6.2.1.
EudraVigilance Database Modules
VI.C.6.2.1.1.
Adverse reaction data collected in the EudraVigilance Post-Authorisation Module
VI.C.6.2.1.2.
Adverse reaction data collected in the EudraVigilance Clinical Trial Module
VI.C.6.2.2.
Preparation of individual case safety reports
VI.C.6.2.2.1.
General principles
VI.C.6.2.2.2.
Information on suspect, interacting and concomitant medicinal products
VI.C.6.2.2.3.
Suspected adverse reactions
VI.C.6.2.2.4.
Case narrative, comments and causality assessment
VI.C.6.2.2.6.
Supplementary records/information
VI.C.6.2.2.7.
Follow-up information
VI.C.6.2.2.8.
Amendment of cases
VI.C.6.2.2.9.
Nullification of cases
VI.C.6.2.2.10.
Data protection laws
VI.C.6.2.2.11.
Handling of languages
VI.C.6.2.3.
Special situations
VI.C.6.2.3.1.
Use of a medicinal product during pregnancy or breastfeeding
VI.C.6.2.3.2.
Suspected adverse reaction reports published in the medical literature
VI.C.6.2.3.4.
Lack of therapeutic efficacy
VI.C.6.2.3.5.
Suspected adverse reactions related to quality defect or falsified medicinal
products
VI.C.6.2.3.6.
Suspected transmission via a medicinal product of an infectious agent
VI.C.6.2.3.8.
Receipt of missing minimum information
VI.C.6.2.5.
Electronic re-transmission of ICSRs between multiple senders and receivers
VI.C.6.3.
Electronic submission of information on medicinal products
VI.
Appendix 1 Process for follow-up of ICSRs
VI.
Appendix 2 Detailed guidance on the monitoring of the medical literature
VI.App.2.1.
When to start and stop searching in the medical literature
VI.App.2.3.1.
Precision and recall
VI.App.2.3.2.
Search construction
VI.App.2.3.3.
Selection of product terms
VI.App.2.3.4.
Selection of search terms
VI.App.2.3.5.
Limits to a search
VI.App.2.6.
Review and selection of articles
VI.App.2.9.
Contracting out literature search services
VI.
Appendix 3 Modalities for the submission of ICSRs in EU
VI.App.3.2.
Requirements applicable to marketing authorisation holders
VI.App.3.3.
Requirements applicable to competent authorities in Member States
VI.
Appendix 4 Submission of ICSRs to the World Health Organization (WHO)
VI.
Appendix 5 Nullification of cases
VI.
Appendix 6 Data quality monitoring of ICSRs transmitted electronically