EMA GVP Module 3

Guideline on good pharmacovigilance practices (GVP) Module III – Pharmacovigilance inspections (Rev 1):

Introduction:

This Module contains guidance on the planning, conduct, reporting and follow-up of pharmacovigilance inspections in the EU and outlines the role of the different parties involved. General guidance is provided under III.B., while III.C. covers the overall operation of pharmacovigilance inspections in the EU.

In order to determine that marketing authorisation holders comply with pharmacovigilance obligations established within the EU, and to facilitate compliance, competent authorities of the Member States concerned shall conduct, in cooperation with the Agency, pharmacovigilance inspections of marketing authorisation holders or any firms employed to fulfil marketing authorisation holder’s pharmacovigilance obligations.

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TABLE OF CONTENTS

III.A. Introduction

III.B. Structures and processes

III.B.1. Inspection types 

III.B.1.1. System and product-related inspections

III.B.1.2. Routine and “for cause” pharmacovigilance inspections

III.B.1.3. Pre-authorisation inspections

III.B.1.4. Post-authorisation inspections

III.B.1.5. Announced and unannounced inspections

III.B.1.6. Re-inspections

III.B.1.7. Remote inspections

III.B.2. Inspection planning

III.B.3. Sites to be inspected

III.B.4. Inspection scope

III.B.4.1. Routine pharmacovigilance inspections

III.B.4.2. For cause inspections

III.B.4.3. Re-inspections

III.B.5. Inspection process

III.B.6. Inspection follow-up

III.B.7. Regulatory actions and sanctions

III.B.8. Record management and archiving

III.B.9. Qualification and training of inspectors

III.B.10. Quality management of pharmacovigilance inspection process

III.C. Operation of the EU network

III.C.1. Sharing of information

III.C.2. Role of the European Medicines Agency

III.C.2.1. General role of the Agency

III.C.2.2. Role of the PRAC

III.C.2.3. Role of the CHMP

III.C.3. Role of the European Commission

III.C.4. Role of the Member States

III.C.5. Role of marketing authorisation holders and applicants

III.C.6. Inspection fees

III.C.7. Transparency 

EMA GVP Module 3: