EMA GVP Product or Population Specific Considerations II

Guideline on good pharmacovigilance practices (GVP) Product- or Population-Specific Considerations II: Biological medicinal products

P.II.A. Introduction:

A biological medicinal product (hereon referred to as ‘biological’) is a medicinal product that contains an active substance that is produced by or extracted from a biological source and that needs for its characterisation and the determination of its quality a combination of physio-chemical-biological testing, together with the production process and its control [Directive 2001/83/EC, Annex 1, Part I, Section 3.2.1.1(b)]. 

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Table of contents

P.II.A. Introduction

P.II.A.1. Pharmacovigilance aspects specific to biologicals

P.II.A.1.1. Immunogenicity

P.II.A.1.2. Manufacturing variability

P.II.A.1.3. Stability and cold chain

P.II.A.1.4. Product traceability

P.II.B. Structures and processes

P.II.B.1. Risk management system

P.II.B.1.1. Content of the risk management plan (RMP)

P.II.B.1.1.1. RMP part I “Product overview”

P.II.B.1.1.2. RMP part II “Safety specification”

P.II.B.1.1.2.1. RMP module SVII “Identified and potential risks” and RMP module SVIII “Summary of the safety concerns”

P.II.B.1.1.2.2. RMP module SVI “Additional EU requirements for the safety specification”

P.II.B.1.1.3. RMP part III “Pharmacovigilance plan”

P.II.B.1.1.3.1. RMP part III section “Routine pharmacovigilance activities”

P.II.B.1.1.3.2. RMP part III section “Additional pharmacovigilance activities”

P.II.B.1.1.4. RMP part V “Risk minimisation measures”

P.II.B.1.2. Updates to the risk management plan due to manufacturing changes

P.II.B.1.2.1. Potential impact of a manufacturing change

P.II.B.1.2.2. Risk analysis

P.II.B.1.2.3. Update of the risk management plan

P.II.B.2. Management and reporting of adverse reactions 

P.II.B.3. Periodic safety update report (PSUR)

P.II.B.3.1. PSUR section “Estimated exposure and use patterns”

P.II.B.3.2. PSUR section “Overview of signals: new, ongoing, or closed” and “Signal and risk evaluation”

P.II.B.4. Signal management

P.II.B.5. Additional monitoring

P.II.B.6. Safety communication

P.II.C. Operation of the EU network

P.II.C.1. Roles and responsibilities 

P.II.C.1.1. Marketing authorisation holder and applicant in the EU

P.II.C.1.1.1. Risk management plan (RMP)

P.II.C.1.1.2. Reporting of adverse reactions and signal management

P.II.C.1.1.3. Periodic safety update report (PSUR)

P.II.C.1.1.4. Additional monitoring

P.II.C.1.1.5. Safety communication

P.II.C.1.2. Competent authorities in Member States

P.II.C.1.2.1. Risk management plan (RMP)

P.II.C.1.2.2. Reporting of adverse reactions

P.II.C.1.2.3. Periodic safety update report (PSUR)

P.II.C.1.3. European Medicines Agency

P.II.C.1.3.1. Pharmacovigilance Risk Assessment Committee

P.II.C.2. Safety communication about biologicals in the EU

EMA GVP Product or Population Specific Considerations II: