EMA GVP Module 10


Guideline on good pharmacovigilance practices (GVP) Module X – Additional monitoring:

Guideline on good pharmacovigilance practices (GVP) Module X – Additional monitoring:


Pharmacovigilance is a vital public health function with the aim of rapidly detecting and responding to potential safety hazards associated with the use of medicinal products.

A medicinal product is authorised on the basis that, its benefit-risk balance is considered to be positive at that time for a specified target population within its approved indication (s). However, not all risks can be identified at the time of initial authorisation and some of the risks associated with the use of a medicinal product emerge or are further characterised in the post-authorisation phase of the product’s lifecycle. . To strengthen the safety monitoring of medicinal products, the 2010 EU Pharmacovigilance legislation, further amended in 2012, has introduced a framework for enhanced risk proportionate post-authorisation data collection for medicinal products, including the concept of additional monitoring for certain medicinal products.

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Table of contents

X.A. Introduction

X.B. Structures and processes

X.B.1. Principles for assigning additional monitoring status to a medicinal product 

X.B.2. Communication and transparency

X.C. Operation of the EU network

X.C.1. Criteria for including a medicinal product in the additional monitoring list

X.C.1.1. Mandatory scope

X.C.1.2. Optional scope 

X.C.2. Criteria for defining the initial time period of maintenance in the additional monitoring list

X.C.2.1. Mandatory scope 

X.C.2.2. Optional scope 

X.C.3. Roles and responsibilities

X.C.3.1. The European Commission

X.C.3.2. The Agency

X.C.3.3. National competent authorities

X.C.3.4. The Pharmacovigilance Risk Assessment Committee (PRAC)

X.C.3.5. The Marketing authorisation holder

X.C.4. Creation and maintenance of the list

X.C.4.1. Process for the creation of the list

X.C.4.2. Process for the maintenance of the list

X.C.4.2.1. Inclusion of medicinal products in the list

X.C.5. Black symbol and explanatory statements

X.C.6. Transparency

EMA GVP Module 10:


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