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

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

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

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

Work instructions for key activities when screening the electronic reaction monitoring reports (eRMRs) for new signals

AdoptedReference Number: WIN/H/3406Legal effective date: 20/04/2023Summary:

Key activities when screening the electronic reaction monitoring reports (eRMRs) for new signals

Standard operating procedure for handling of safety information from non-EEA regulatory authorities

AdoptedReference Number: SOP/H/3382Legal effective date: 28/11/2018Summary:

This SOP describes the current process followed in the Pharmacovigilance and Epidemiology Department (P-PE) in order to distribute, evaluate and track safety information emerging from preand

post-authorisation surveillance conducted by other regulatory authorities for Centrally Authorised Products (CAPs) and substances.

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

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

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

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

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

AdoptedReference Number: SOP/H/3341Legal 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

AdoptedReference Number: WIN/H/3369Legal 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

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

Work instructions on training for signal validators

AdoptedReference Number: WIN/H/3364Legal effective date: 07/12/2015

Standard operating procedure on data analysis of EudraVigilance

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

Standard operating procedure for signal management

AdoptedReference Number: SOP/H/3065Legal effective date: 06/12/2018Summary:

Signal management

Standard operating procedure for management of general external pharmacovigilance-related queries assigned to the pharmacovigilance dashboard in JIRA

AdoptedReference Number: SOP/H/3293Legal effective date: 12/01/2016

Work instructions for maintenance of signal management tracking table

AdoptedReference Number: WIN/H/3268Legal effective date: 06/12/2018Summary:

Work instructions for maintenance of signal management tracking table

Work instructions for review of active substances in products under evaluation in the centralised procedure (from SIAMED listing)

AdoptedReference Number: WIN/H/3284Legal effective date: 12/10/2011

Work instructions for validation of signals from the review of individual cases

AdoptedReference Number: WIN/H/3287Legal effective date: 29/11/2018Summary:

Update, in line with Revision 1 of GVP Module IX, of the instructions concerning signals validation activities for Centrally Authorised medicinal Products (CAPs) and Nationally Authorised medicinal

Products (NAPs) which contain the same active substance of the concerned CAPs.

Work Instructions for design of an analysis of EudraVigilance data

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