Overview of 2012 GVP Modules

Good Pharmacovigilance Practices (GVP) are a set of measures drawn up by the European Medicines Agency
(EMA) and the medicines regulatory authorities (i.e. competent authorities) in EU Member States, to facilitate
the implementation of the July 2012 Pharmacovigilance (PV) legislation and conduct of PV in the EU.

The guidance on GVP is organised into two types of chapters – modules on pharmacovigilance processes,
and product or population-specific considerations. The focus of the PIPA training is on the following
GVP Modules:

Module I: Pharmacovigilance Systems and their Quality Systems
Module II: Pharmacovigilance System Master File
Module III: Pharmacovigilance Inspections
Module IV: Pharmacovigilance Audits
Module V: Risk Management Systems
Module VI: Module VI – Collection, Management and Submission of Reports of Suspected Adverse
Reactions to Medicinal Products
Module VI: Addendum I: Duplicate Management of Suspected Adverse Reaction Reports
Module VII: Periodic Safety Update Report
Module VIII: Post-authorisation Safety Studies
Module VIII: Addendum I: Requirements and recommendations for the submission of information on
non-interventional post authorisation safety studies
Module IX: Signal Management
Module IX: Addendum I: Methodological Aspects of Signal Detection from Spontaneous Reports of
Suspected Adverse Reactions.
Module X: Additional Monitoring
Module XV: Safety Communication
Module XVI: Risk Minimisation Measures: Selection of Tools and Effectiveness Indicators.
Module XVI: Addendum I: Educational materials

Where GVP chapters refer to Modules XI or XIV, consult the Agency’s page on partners and
Where GVP chapters refer to Module XII, consult the Agency’s page on post-marketing
authorisation: regulatory and procedural guidance for human medicinal products.
Where GVP chapters refer to Module XIII, consult the Agency’s page on the incident
management plan