EMA GVP Product or Population Specific Considerations I


Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases:

Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations I: Vaccines for prophylaxis against infectious diseases:

P.I.A. Introduction:

Vaccination is one of the most effective and widely used public health interventions, whose benefits for individuals and the community have been abundantly demonstrated. Prominent examples are the global eradication of smallpox and the elimination of poliomyelitis in most countries. As with any other pharmaceutical product, however, no vaccine is without risks. Robust systems and procedures must be in place to continuously monitor quality, safety and efficacy. Vaccine pharmacovigilance has been defined by the CIOMS/WHO Working Group on Vaccine Pharmacovigilance as the science and activities related to the detection, assessment, understanding and communication of adverse events following immunisation and other vaccine- or immunisation-related issues, and to the prevention of untoward effects of the vaccine or immunisation.

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Table of Contents

P.I.A. Introduction

P.I.A.1. Terminology 

P.I.A.2. Aspects specific to prophylactic vaccines 

P.I.A.3. Changes of the benefit-risk balance

P.I.A.3.1. Efficacy and effectiveness

P.I.A.3.2. Biological variability

P.I.A.4. Aspects related to vaccination programmes

P.I.B. Structures and processes

P.I.B.1. Risk management system

P.I.B.1.1. RMP part I “Product overview”

P.I.B.1.2. RMP part II “Safety specification” 

P.I.B.1.2.1. RMP module SI “Epidemiology of the indications and target population”

P.I.B.1.2.2. RMP module SII “Non-clinical part of the safety specification”

P.I.B.1.2.3. RMP module SIV “Populations not studied in clinical trials”

P.I.B.1.2.4. RMP module SVI “Additional EU requirements for the safety specification”

P.I.B.1.2.5. RMP module SVII “Identified and potential risks”

P.I.B.1.2.6. RMP module SVIII “Summary of the safety concerns”

P.I.B.1.3. RMP part III “Pharmacovigilance plan”

P.I.B.1.3.1. RMP section “Routine pharmacovigilance activities” 

P.I.B.1.3.2. RMP section “Additional pharmacovigilance activities”

P.I.B.1.4. RMP part IV “Plans for post-authorisation efficacy studies”

P.I.B.1.5. RMP part V “Risk minimisation measures”

P.I.B.2. Periodic safety update report

P.I.B.2.1. Integrated benefit-risk analysis

P.I.B.3. Post-authorisation safety studies

P.I.B.4. Signal management

P.I.B.4.1. Standard case definitions

P.I.B.4.2. Single report of a serious adverse event

P.I.B.4.3. Signal detection in mass vaccination programmes

P.I.B.4.4. Disproportionality analyses 

P.I.B.4.5. Observed to expected analyses 

P.I.B.4.6. Signal evaluation

P.I.B.5. Batch recall and quarantine 

P.I.B.5.1. Data requirements

P.I.B.5.2. Action based on clinical events in the absence of a known quality issue

P.I.B.5.3. Action due to identified quality deviations

P.I.B.6. Safety communication

P.I.C. Operation of the EU network

P.I.C.1. Roles and responsibilities

P.I.C.1.1. Vaccinated persons and parents/carers

P.I.C.1.2. Healthcare professionals

P.I.C.1.3. Marketing authorisation holders

P.I.C.1.4. Competent authorities in Member States

P.I.C.1.5. European Medicines Agency 

P.I.C.2. Reporting of reactions and emerging safety issues

P.I.C.2.1.Reporting of vaccination failures

P.I.C.3. Risk Management System

P.I.C.4. Signal management

P.I.C.5. Safety communication about vaccines in the EU

P.I.C.6. Transparency of pharmacovigilance for vaccines in the EU

P.I.C.7. Vaccines intended for markets outside the EU

EMA GVP Product or Population Specific Considerations I:

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