GVP – Module II: Pharmacovigilance system master file

REVISION 2 in force from: 31. 3. 2017

MODULE - FULL TEXT

Module II: Pharmacovigilance system master file (full text)

MODULE - DETAILS

II.A. Introduction

II.A. Introduction

II.B. Structures and processes

II.B. Structures and processes

II.B.1. Objectives

II.B.2. Registration and maintenance

II.B.3. The representation of pharmacovigilance systems

II.B.4. Information to be contained in the pharmacovigilance system master file

II.B.5 Change control, logbook, versions and archiving

II.B.6. Pharmacovigilance system master file presentation

II.C. Operation of the EU network

II.C.1. Responsibilities

II.C.2. Accessibility of the pharmacovigilance system master file

II.C.3. Transparency