IX.A. Introduction
Regulation (EC) No 726/2004, Directive 2001/83/EC and Commission Implementing Regulation (EU) No 520/2012 (hereinafter referred to as REG, DIR and IR, respectively) include provisions for signal management in the European Union (EU) [DIR Art 107h, REG Art 28a, IR Chapter III].
In this Module, all applicable legal requirements are referenced as explained in the GVP Introductory Cover Note and are usually identifiable by the modal verb “shall”. Guidance for the implementation of legal requirements is provided using the modal verb “should”.
The objectives of this Module are to:
- provide general guidance and requirements on scientific and quality aspects of signal management (IX.B.);
- describe roles, responsibilities and procedural aspects in the setting of the EU signal management process overseen by the Pharmacovigilance Risk Assessment Committee (PRAC) (IX.C.).
This Module is applicable to medicinal products for human use authorised in the EU irrespective of the authorisation procedure (centralised or national procedure, including mutual recognition and decentralised).
Unless stated otherwise, the guidance provided in the Module applies to all organisations involved in signal management, i.e. marketing authorisation holders, national competent authorities and the European Medicines Agency (the ‘Agency’).
Individual organisations may follow alternative signal management processes and terminology but should encompass the general principles outlined in this Module.
An addendum to this Module, the GVP Module IX Addendum I, describes methodological aspects of signal detection from spontaneous reports of suspected adverse reactions.
The following documents provide additional guidance relevant to signal management: