Pharmacovigilance procedures for human medicines

Standard operating procedure for validation, publication, and maintenance of real-world data sources and studies in the HMA-EMA RWD Catalogues

Adopted Reference Number: EMA/467789/2024 Legal effective date: 02/05/2025

Standard operating procedure for tracking and handling in SIAMED of SDA post-authorisation measures for centrally authorised products

Adopted Reference Number: SOP/H/3441 Legal effective date: 10/04/2017

Standard operating procedure for handling of requests for ADR-related EudraVigilance data

Adopted Reference Number: SOP/H/3326 Legal effective date: 07/12/2018 Summary:

This document describes the process followed by the Inspection and Human Pharmacovigilance

department (P-PE) and the Information Management division (I) when a request for EudraVigilance

data, i.e. information about a suspected adverse reaction associated with a medicinal product and/or a

substance contained in EudraVigilance, is received from within the EU regulatory network, e.g. the

European Medicines Agency, the European Commission, the Committee for Medicinal Products for

Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC) and the National

Competent Authorities (NCAs).

Standard operating procedure on handling of European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) study seal applications

Adopted Reference Number: SOP/H/3362 Legal effective date: 24/06/2011

Standard operating procedure for European Pharmacovigilance Issues Tracking Tool user registration and management

Adopted Reference Number: SOP/H/3341 Legal effective date: 12/10/2016

Work instructions for user registration and management - Maintenance of the European Pharmacovigilance Issues Tracking Tool (EPITT) accounts and provision of trainings to users

Adopted Reference Number: WIN/H/3369 Legal effective date: 12/10/2016

Work instructions for European Pharmacovigilance Issues Tracking Tool (EPITT) user registration and management – Assessment of eligibility for an EPITT account

Adopted Reference Number: WIN/H/3367 Legal effective date: 12/10/2016

Standard operating procedure on data analysis of EudraVigilance

Adopted Reference Number: SOP/H/3289 Legal effective date: 17/12/2018

Work Instructions for design of an analysis of EudraVigilance data

Adopted Reference Number: WIN/H/3290 Legal effective date: 17/12/2018