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Final September 2008

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VOLUME 9A

of The Rules Governing Medicinal Products in the European Union

Guidelines on Pharmacovigilance for Medicinal Products for Human Use –

GENERAL OUTLINE OF CONTENTS

INTRODUCTION

1. Legal Basis and Structure of Volume 9A (Human Pharmacovigilance)

2. Legal Framework for Pharmacovigilance

3. The Roles of the Various Parties PART I – Guidelines for Marketing Authorisation Holders

1. General Principles

2. Requirements for Pharmacovigilance Systems, Monitoring of Compliance and Pharmacovigilance Inspections

3. Requirements for Risk Management Systems

4. Requirements for Expedited Reporting of Individual Case Safety Reports

5. Requirements for Reporting in Special Situations

6. Requirements for Periodic Safety Update Reports

7. Company-Sponsored Post-Authorisation Safety Studies

8. Overall Pharmacovigilance Evaluation and Safety-Related Regulatory Action PART II – Guidelines for Competent Authorities and the Agency

1. Undertaking of Pharmacovigilance Activities by Competent Authorities in Member States

2.A Conduct of Pharmacovigilance for Centrally Authorised Products

2.B Crisis Management Plan regarding Centrally Authorised Products

3. Conduct of Pharmacovigilance for Medicinal Products Authorised through the Mutual Recognition or Decentralised Procedure

4. Rapid Alert and Non-Urgent Information System in Pharmacovigilance

5. Referrals in Case of Safety Concerns Related to Products Authorised in the EU and Commission Decisions Following Suspension, Revocation or Variation of a Medicinal Product by a Member State

6. Principles of Collaboration with the World Health Organization in Matters of International Pharmacovigilance PART III – Guidelines for Marketing Authorisation Holders, Competent Authorities and the Agency on Electronic Exchange of Pharmacovigilance Information in the EU PART IV – Guidelines for Marketing Authorisation Holders and Competent Authorities on Pharmacovigilance Communication

1. Introduction

2. Direct Healthcare Professional Communications 2/229

ANNEXES

1. Glossary

2. Abbreviations

3. Other EU Guidelines and Relevant Terminology

4. ICH Guidelines

5. Templates

6. Distribution Requirements and Address Lists for Data Submission 3/229

DETAILED TABLE OF CONTENTS

INTRODUCTION _________________________________________________________ 14 1. Legal Basis and Structure of Volume 9A (Human Pharmacovigilance) __________ 14 2. Legal Framework for Pharmacovigilance___________________________________ 15 3. The Roles of the Various Parties __________________________________________ 16 3.1 The Marketing Authorisation Holder ________________________________________ 16 3.2 The Competent Authorities ________________________________________________ 16 3.2.1 The Competent Authorities of the Member States ______________________________ 16 3.2.2 The European Commission ________________________________________________ 16 3.3 The EU Pharmacovigilance System _________________________________________ 16 3.3.1 The Role of Competent Authorities of the Member States for Products Authorised Through National Procedures _____________________________________________________ 16 3.3.2 The Role of the Competent Authority of the Reference Member State for Products Authorised Through the Mutual Recognition or Decentralised Procedure ____________ 16 3.3.3 The Role of the Rapporteur for Products Authorised Through the Centralised Procedure 17 3.3.4 The Role of the Agency___________________________________________________ 17 3.3.5 The Role of the CHMP Pharmacovigilance Working Party _______________________ 17

PART I: GUIDELINES FOR MARKETING AUTHORISATION HOLDERS_____________ 18

1. General Principles ______________________________________________________ 19 1.1 Legal Basis of the Marketing Authorisation Holder’s Obligations for Pharmacovigilance 19 1.2 Roles and Responsibilities of the Marketing Authorisation Holder and the Qualified Person Responsible for Pharmacovigilance _________________________________________ 19 1.2.1 The Role and Responsibilities of the Qualified Person Responsible for Pharmacovigilance ______________________________________________________________________ 20 1.2.2 Responsibilities of the Marketing Authorisation Holder in Relation to the Qualified Person Responsible for Pharmacovigilance _________________________________________ 21 1.3 Contractual Arrangements_________________________________________________ 21 2. Requirements for Pharmacovigilance Systems, Monitoring of Compliance and Pharmacovigilance Inspections ___________________________________________ 22 2.1 Introduction ____________________________________________________________ 22 2.1.1 Roles of the Marketing Authorisation Holder __________________________________ 22 2.1.2 Roles of the Agency _____________________________________________________ 22 2.1.3 Roles of the Competent Authorities in Member States ___________________________ 22 2.1.4 Pharmacovigilance Inspections _____________________________________________ 23 2.1.5 Detailed Description of the Pharmacovigilance System to Be Included in the Marketing Authorisation Application _________________________________________________ 23 2.1.6 Proof of the Services of a QPPV and of the Necessary Means to Notify Adverse Reactions, to be Included in the Marketing Authorisation Application _______________________ 23 2.2 Detailed Description of the Pharmacovigilance System __________________________ 23 2.2.1 Location in the Marketing Authorisation Application and Update of the Detailed Description ____________________________________________________________ 23 2.2.2 Statement of the Marketing Authorisation Holder and the QPPV Regarding their Availability and the Means for the Notification of Adverse Reactions ______________ 23 2.2.3 Elements of the Detailed Description of the Pharmacovigilance System _____________ 24 2.2.3.a) Qualified Person Responsible for Pharmacovigilance (QPPV) ____________________ 24 2.2.3.b) Organisation ___________________________________________________________ 24 2.2.3.c) Documented Procedures __________________________________________________ 24 4/229 2.2.3.d) Databases______________________________________________________________ 26 2.2.3.e) Contractual Arrangements with Other Persons or Organisations Involved in the Fulfilment of Pharmacovigilance Obligations __________________________________________ 26 2.2.3.f) Training _______________________________________________________________ 26 2.2.3.g) Documentation _________________________________________________________ 26 2.2.3.h) Quality Management System ______________________________________________ 26 2.2.3.i) Supporting Documentation ________________________________________________ 27 2.3 Monitoring of Compliance by the Competent Authorities ________________________ 27 2.3.1 Qualified Person Responsible for Pharmacovigilance ___________________________ 27 2.3.2 Availability of Pharmacovigilance Data ______________________________________ 27 2.3.3 Change in the Evaluation of the Risk-Benefit Balance of a Product_________________ 28 2.3.4 Expedited Adverse Reaction Reporting ______________________________________ 28 2.3.5 Periodic Safety Update Reports ____________________________________________ 28 2.3.6 Information Requested by Competent Authorities ______________________________ 29 2.3.7 Submission of Safety Variations ____________________________________________ 29 2.3.8 CHMP Commitments in Respect of Centrally Authorised Products ________________ 29 2.3.9 Post-Authorisation Safety Studies___________________________________________ 30 2.3.10 Provision of Additional Data on Studies ______________________________________ 30 2.4 Pharmacovigilance Inspections _____________________________________________ 30 2.4.1 Conduct of Inspections ___________________________________________________ 30 2.4.2 Routine Inspections ______________________________________________________ 31 2.4.3 Targeted Inspections _____________________________________________________ 31 2.4.4 Pharmacovigilance System Inspections ______________________________________ 32 2.4.5 Product-Specific Inspections_______________________________________________ 32 2.4.6 Requesting and Reporting of Inspections _____________________________________ 32 2.4.7 Inspections of Contractors and Licensing Partners ______________________________ 33 2.4.8 Inspections in European Economic Area _____________________________________ 33 2.4.9 Inspections in Third Countries _____________________________________________ 33 2.4.10 Fees for Inspections Requested by the CHMP _________________________________ 33 2.4.11 Procedures for Coordination of Pharmacovigilance Inspection for Centrally Authorised Products_______________________________________________________________ 33 2.4.12 Procedures for Pharmacovigilance Inspections_________________________________ 33 2.4.13 Unannounced Inspections _________________________________________________ 34 2.4.14 Inspection Reports_______________________________________________________ 34 2.4.15 Follow-up of Inspection Findings ___________________________________________ 34 2.4.16 Sharing of inspection information ___________________________________________ 34 2.5 Regulatory Action _______________________________________________________ 34 3. Requirements for Risk Management Systems _______________________________ 36 3.1 Introduction ____________________________________________________________ 36 3.2 Description of the Risk Management System __________________________________ 38 3.3 EU Risk Management Plan (EU-RMP)_______________________________________ 38 3.4 Situations Requiring an EU-RMP ___________________________________________ 39 3.4.1 Marketing Authorisations via the Centralised Procedure _________________________ 39 3.4.2 Marketing Authorisations via the Mutual Recognition or Decentralised Procedures ____ 40 3.5 Location in the Application________________________________________________ 40 3.6 Safety Specification______________________________________________________ 40 3.6.1 Non-clinical Part of the Safety Specification __________________________________ 41 3.6.2 Clinical Part of the Safety Specification ______________________________________ 41 3.6.2.a) Limitations of the Human Safety Database____________________________________ 41 3.6.2.b) Populations Not Studied in the Pre-Authorisation Phase _________________________ 41 3.6.2.c) Adverse Events/Adverse Reactions__________________________________________ 42 3.

6.2.d) Identified and Potential Interactions including Food-Drug and Drug-Drug Interactions _ 43 3.6.2.e) Epidemiology __________________________________________________________ 43 3.6.2.f) Pharmacological Class Effects _____________________________________________ 44 5/229 3.6.2.g) Additional EU Requirements ______________________________________________ 44 3.6.3 Summary ______________________________________________________________ 45 3.7 Pharmacovigilance Plan __________________________________________________ 45 3.7.1 Routine Pharmacovigilance________________________________________________ 45 3.7.2 Additional Pharmacovigilance Activities and Action Plans _______________________ 45 3.7.3 Action Plan for Safety Concerns ____________________________________________ 46 3.8 Evaluation of the Need for Risk Minimisation Activities _________________________ 46 3.8.1 Potential for Medication Errors _____________________________________________ 47 3.9 The Risk Minimisation Plan _______________________________________________ 47 3.10 Risk Minimisation Activities_______________________________________________ 48 3.10.1 Risk Communication_____________________________________________________ 48 3.11 The Marketing Authorisation ______________________________________________ 48 3.12 Ensuring the Effectiveness of Risk Minimisation Activities_______________________ 49 3.12.1 Assessment of Risk Minimisation ___________________________________________ 49 3.13 Summary of Activities in the EU-RMP_______________________________________ 49 3.14 Submission of Updated EU-RMP Documents _________________________________ 50 TABLE I.3.A: METHODS FOR RISK MINIMISATION ___________________________________________________________ 52 4. Requirements for Expedited Reporting of Individual Case Safety Reports _______ 56 4.1 Introduction ____________________________________________________________ 56 4.2 Reporting Time Frames___________________________________________________ 57 4.3 Requirements by Reporting Source__________________________________________ 58 4.3.1 Spontaneous Reports from Healthcare Professionals ____________________________ 58 4.3.2 Reports Published in the Worldwide Literature ________________________________ 60 4.3.3 Information on Adverse Reactions from the Internet ____________________________ 61 4.3.4 Reports from Organised Data Collection Systems ______________________________ 61 4.3.5 Reports from Patients and Other Consumers __________________________________ 62 4.3.6 Reports from Other Non-Medical Sources ____________________________________ 62 4.4 Data Elements for the Report ______________________________________________ 62 4.5 Method of Reporting _____________________________________________________ 63 5. Requirements for Reporting in Special Situations ____________________________ 64 5.1 Introduction ____________________________________________________________ 64 5.2 Reporting in the Period between the Submission of the Marketing Authorisation Application and the Granting of the Marketing Authorisation _____________________ 64 5.3 Reporting Following Suspension or Withdrawal of the Marketing Authorisation for Safety or Commercial Reasons___________________________________________________ 64 5.4 Reporting of Outcomes of Use of a Medicinal Product During Pregnancy ___________ 65 5.5 Reporting of Adverse Reactions during Breastfeeding ___________________________ 66 5.6 Reporting of Data on Use of Medicinal Products in Children _____________________ 66 5.7 Reporting from Compassionate/Named-Patient Use_____________________________ 66 5.8 Reporting of Lack of Efficacy______________________________________________ 66 5.9 Reporting of Suspected Transmission of Infectious Agents _______________________ 67 5.10 Reporting in Relation to Overdose, Abuse and Misuse___________________________ 68 5.11 Reporting of Medication Errors ____________________________________________ 68 5.

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