GVP – Module VI: Collection, management and submission of reports of suspected adverse reactions to medicinal products

REVISION 2 in force from: 22. 11. 2017

MODULE - FULL TEXT

MODULE - DETAILS

VI.A. Introduction

VI.A.1. Terminology
VI.A. Introduction

VI. B. Structures and processes

VI.B.1. Collection of individual safety reports
VI.B.2. Validation of reports
VI.B.3. Follow-up of reports
VI.B.4. Data management
VI.B.5. Quality management
VI.B.6. Special situations
VI.B.7. Submission of individual case safety reports (ICSRs)
VI.B.8. Modalities for submission of individual case safety reports (ICSRs)

VI.C Operation of EU network

VI.C. Operation of the EU network
VI.C.1. Management of individual safety reports for clinical trials, postauthorisation studies, compassionate use and named patient use in the EU
VI.C.2. Collection of individual safety reports
VI.C.3. Submission time frames of ICSRs in EU
VI.C.4. Submission modalities of ICSRs in EU
VI.C.5. Collaboration with the World Health Organization and the European Monitoring Centre for Drugs and Drug Addiction
VI.C.6. Electronic exchange of safety information in the EU

VI. Appendix

VI. Appendix 1 Process for follow-up of ICSRs
VI.App.1.2. Follow-up of ICSRs by competent authorities in Member States with involvement of marketing authorisation holders
VI.App.2.1. When to start and stop searching in the medical literature
VI.App.2.2. Where to look
VI.App.2.3. Database Searches
VI.App.2.4. Record keeping
VI.App.2.5. Outputs
VI.App.2.6. Review and selection of articles
VI.App.2.7. Day zero
VI.App.2.8. Duplicates
VI.App.2.9. Contracting out literature search services
VI.App.2.10. Electronic submission of copies of articles on suspected adverse reactions published in the medical literature
VI.App.2.11. Examples for the submission as ICSRs of suspected adverse reactions described in the medical literature and referring to more than one patient
VI.App.3.1. Modalities applicable to competent authorities in Member States and to marketing authorisation holders
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.App.3.4. Rerouting to competent authorities in Member States of ICSRs submitted to EudraVigilance by marketing authorisation holders
VI. Appendix 5 Nullification of cases
VI. Appendix 6 Data quality monitoring of ICSRs transmitted electronically
VI.App.7.1. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders – Duplicate ICSRs submitted to EudraVigilance by the same sender and identified by the Agency
VI.App.7.2. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders– Duplicate ICSRs submitted to EudraVigilance by different senders and identified by the Agency
VI.App.7.3. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders – Duplicate ICSRs submitted to EudraVigilance by the same sender and identified by the sender organisation prior to the detection by the Agency
VI.App.7.4. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders – Duplicate ICSRs submitted to EudraVigilance by different senders and identified by an organisation prior to the detection by the Agency
VI.App.7.5. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders – Duplicate ICSRs identified as part of signal management as outlined in GVP Module IX