Pharmacovigilance procedures for human medicines

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

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

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

AdoptedLegal effective date: 20/04/2023Reference Number: WIN/H/3406Summary:

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

AdoptedLegal effective date: 28/11/2018Reference Number: SOP/H/3382Summary:

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 evaluation procedure – European Network of Centres for Pharmacoepidemiology and Pharmacovigilance database of research resources

AdoptedLegal effective date: 01/12/2011Reference Number: SOP/H/3363Summary:

The purpose of this SOP is to provide a harmonised approach for members of the ENCePP Secretariat to handle applications received via the ENCePP database of research resources from research centres, networks and data sources wishing to join ENCePP. It is designed to ensure that such applications are handled in an efficient and consistent manner.

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

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

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

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

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

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

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

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

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

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

Work instructions on training for signal validators

AdoptedLegal effective date: 07/12/2015Reference Number: WIN/H/3364

Standard operating procedure on data analysis of EudraVigilance

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

Standard operating procedure for signal management

AdoptedLegal effective date: 06/12/2018Reference Number: SOP/H/3065Summary:

Signal management

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

AdoptedLegal effective date: 12/01/2016Reference Number: SOP/H/3293

Work instructions for maintenance of signal management tracking table

AdoptedLegal effective date: 06/12/2018Reference Number: WIN/H/3268Summary:

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)

AdoptedLegal effective date: 12/10/2011Reference Number: WIN/H/3284

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

AdoptedLegal effective date: 29/11/2018Reference Number: WIN/H/3287Summary:

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

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