EMA GVP Module 1

Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems:

Introduction:

This Module contains guidance for the establishment and maintenance of quality assured pharmacovigilance systems for marketing authorisation holders, competent authorities of Member States and the Agency. How the systems of these organisations interact while undertaking specific pharmacovigilance processes is described in each respective Module of GVP.

The definition of a pharmacovigilance system is provided in Article 1 of Directive 2001/83/EC as a system used by the marketing authorisation holder and by Member States to fulfil the tasks and responsibilities listed in Title IX and designed to monitor the safety of authorised medicinal products and detect any change to their risk-benefit balance. The Agency likewise maintains a pharmacovigilance system to fulfil its pharmacovigilance activities.

Click on the titles below for complete guidelines

Table of contents

I.A. Introduction 

I.B. Structures and processes

I.B.1. Pharmacovigilance system 

I.B.2. Quality, quality objectives, quality requirements and quality system 

I.B.3. Quality cycle

I.B.4. Overall quality objectives for pharmacovigilance 

I.B.5. Principles for good pharmacovigilance practices 

I.B.6. Responsibilities for the quality system within an organisation 

I.B.7. Training of personnel for pharmacovigilance 

I.B.8. Facilities and equipment for pharmacovigilance

I.B.9. Specific quality system procedures and processes 

I.B.9.1. Compliance management by marketing authorisation holders 

I.B.9.2. Compliance management by competent authorities 

I.B.10. Record management

I.B.11. Documentation of the quality system

I.B.11.1. Additional quality system documentation by marketing authorisation holders

I.B.11.2. Additional quality system documentation by competent authorities

I.B.11.3. Critical pharmacovigilance processes and business continuity

I.B.12. Monitoring of the performance and effectiveness of the pharmacovigilance system and its quality system 

I.B.13. Preparedness planning for pharmacovigilance in public health emergencies

I.C. Operation of the EU network

I.C.1. Overall pharmacovigilance responsibilities of the applicant and marketing authorisation holder in the EU

I.C.1.1. Responsibilities of the marketing authorisation holder in relation to the qualified person responsible for pharmacovigilance in the EU 

I.C.1.2. Qualifications of the qualified person responsible for pharmacovigilance in the EU

I.C.1.3. Role of the qualified person responsible for pharmacovigilance in the EU

I.C.1.4. Specific quality system processes of the marketing authorisation holder in the EU

I.C.1.5. Quality system requirements for pharmacovigilance tasks subcontracted by the marketing authorisation holder 

I.C.2. Overall pharmacovigilance responsibilities within the EU regulatory network

I.C.2.1. Role of the competent authorities in Member States 

I.C.2.2. Role of the European Commission 

I.C.2.3. Role of the European Medicines Agency

I.C.2.3.1. General role of the Agency and the role of the Agency’s secretariat 

I.C.2.3.2. Role of the Pharmacovigilance Risk Assessment Committee (PRAC) 

I.C.2.3.3. Role of the Committee for Medicinal Products for Human Use (CHMP)

I.C.2.3.4. Role of the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) 

I.C.2.4. Specific quality system processes of the quality systems of competent authorities in Member States and the Agency

I.C.2.5. Quality system requirements for pharmacovigilance tasks delegated or transferred by competent authorities in Member States

I.C.2.6. Transparency of the quality system of the EU regulatory network

I.C.3. Data protection in the EU 

I.C.4. Preparedness planning in the EU for pharmacovigilance in public health emergencies

EMA GVP Module 1: