EMA GVP Module 6

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Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2):

Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (Rev 2):

Introduction:

This Module of GVP addresses the legal requirements detailed in Directive 2001/83/EC [DIR] and Regulation (EC) No 726/2004 [REG], which are applicable to competent authorities in Member States, marketing authorisation holders and the Agency as regards the collection, data management and submission of individual reports of suspected adverse reactions (serious and non-serious) associated with medicinal products for human use authorised in the European Union (EU). 

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TABLE OF CONTENTS

VI.A. Introduction

VI.A.1. Terminology

VI.A.1.1. Adverse reaction, causality

VI.A.1.2. Overdose, off-label use, misuse, abuse, occupational exposure, medication error, falsified medicinal product

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.1.6. Seriousness

VI.A.1.7. Individual case safety report (ICSR)

VI.A.1.8 nullFlavors

VI.B. Structures and processes

VI.B.1. Collection of individual safety reports

VI.B.1.1. Unsolicited 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.1.2. Solicited 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.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.7.3. Report amendment

VI.B.8. Modalities for submission of individual case safety reports (ICSRs) 

VI.C. Operation of the EU network

VI.C.1. Management of individual safety reports for clinical trials, post-authorisation studies, compassionate use and named patient use in the EU

VI.C.1.1. Management of individual safety reports for clinical trials

VI.C.1.2. Management of individual safety reports for non-interventional post-authorisation studies, compassionate use and named patient use

VI.C.1.2.1. Non-interventional post-authorisation studies 

VI.C.1.2.1.1. Non-interventional post-authorisation studies with a design based on primary data collection

VI.C.1.2.1.2. Non-interventional post-authorisation studies with a design based on secondary use of data

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.2.2.2. Solicited 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.2.2.7. Period between the submission of the marketing authorisation application and the granting of the marketing authorisation

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.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.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.6.2.2.5. Test results

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.6.2.3.3. Suspected adverse reactions related to overdose, abuse, off-label use, misuse, medication error or occupational exposure

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.6.2.3.7. Reports of suspected adverse reactions originating from organised data collection systems and other systems

VI.C.6.2.3.8. Receipt of missing minimum information 

VI.C.6.2.4. Data quality of individual case safety reports transmitted electronically and duplicate management

VI.C.6.2.5. Electronic re-transmission of ICSRs between multiple senders and receivers

VI.C.6.2.6. Electronic submission of ICSRs through the headquarter of a marketing authorisation holder 

VI.C.6.3. Electronic submission of information on medicinal products 

VI. Appendix 1 Process for follow-up of ICSRs

VI.App.1.1. Follow-up of ICSRs by competent authorities in Member States and marketing authorisation holders

VI.App.1.2. Follow-up of ICSRs by competent authorities in Member States with involvement of marketing authorisation holders

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.2.2. Where to look

VI.App.2.3. Database Searches

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.2.4. 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. Appendix 3 Modalities for the submission of ICSRs in EU

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.App.3.4. Rerouting to competent authorities in Member States of ICSRs submitted to EudraVigilance by marketing authorisation holders

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

VI. Appendix 7 Duplicate detection and management of ICSRs


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