GVP – Module XVI: Risk minimisation measures

REVISION 3 in force from: 6. 8. 2024

MODULE - FULL TEXT

MODULE - DETAILS

XVI.A. Introduction

XVI.A. Introduction

XVI.A.1. Terminology

XVI.B. Structures and processes

XVI.B.1. Principles of risk minimisation

XVI.B.2. Categories and tools of risk minimisation measures

XVI.B.3. Requiring and selecting tools of additional risk minimisation measures

XVI.B.4. Developing materials and dissemination plans for additional risk minimisation measures

XVI.B.5. Evaluating the effectiveness of risk minimisation measures

XVI.B.6. Adapting risk minimisation measures within the benefit-risk management cycle of the medicinal product

XVI.B.7. Quality systems for risk minimisation

XVI.C. Operation of the EU network

XVI.C.2. Responsibilities of the applicant/marketing authorisation holder in the EU

XVI.C.3. Responsibilities of the EU regulatory network

XVI.C.4. Transparency

XVI. Appendix 1

XVI.App1.1. Summary of product characteristics

XVI.App1.2. Package leaflet

XVI.App1.3. Labelling of immediate and outer packaging

XVI.App1.4. Pack size

XVI.App1.5. Classification of the medicinal product (legal status)

XVI. Appendix 2

XVI.App2.1. Guides for risk minimisation for patients or healthcare professionals

XVI.App2.2. Healthcare professional checklist for risk minimisation

XVI.App2.3. Risk awareness dialogue form/aid

XVI.App2.4. Patient card

XVI.App2.5. Patient diary for risk minimisation