GVP – Module X: Additional monitoring

X.A. Introduction

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

X.C.3. Roles and responsibilities

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

X.C.5. Black symbol and explanatory statements

X.C.6. Transparency