EMA EudraVigilance Registration Manual

1 Official address Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands An agency of the European Union Address for visits and deliveries Refer to Send us a question Go to Telephone +31 (0)88 781 6000 European Medicines Agency, 2022. Reproduction is authorised provided the source is acknowledged. 17 March 2022 EMA/13454/2020, Rev. 11 Data Analytics and Methods EMA EudraVigilance Registration Manual EMA EudraVigilance Registration Manual EMA/109955/2022 Page 2/69 Table of contents 1. Registration overview .. 4 2. EMA Account Management portal (IAM) .. 6 Registering with the EMA Account Management portal.

2 6 Log into EMA Account Management portal .. 12 Change password in EMA Account Management portal .. 12 Update security (authentication) questions .. 14 Reset forgotten password .. 15 Retrieve forgotten username .. 18 Request removal of your access to a system .. 20 3. Organisation information in OMS system .. 22 OMS user Registration .. 22 Search OMS information .. 24 Create a new Organisation in OMS .. 24 Update organisation details in OMS .. 26 4. Register a new Organisation in EudraVigilance .. 27 EU QPPV or Responsible Person access request .. 27 Finalise organisation information in EV Human Production and XCOMP .. 30 33 5.

3 EudraVigilance User access management .. 33 EV user access requests for industry and NCA users .. 34 Multiple EV roles .. 39 Role approval for EudraVigilance .. 39 Approval process managed by EU QPPV/RP/TD .. 40 EU QPPV/RP/TD user responsibilities .. 44 Removing (Revoke) access .. 45 Revoke an EV user role as an EU QPPV/RP/Trusted Deputy .. 45 Policy violation .. 46 6. EudraVigilance Organisation Management .. 47 EV restricted area and transmission mode for new organisation .. 48 WebTrader and Gateway transmission mode set up .. 48 Change of transmission mode from WebTrader to Gateway .. 48 Manage organisation hierarchy in the Production system.

4 48 Affiliates .. 49 MERGE organisations (create or move an affiliate) .. 49 SPLIT organisations .. 52 SWAP organisations .. 52 Virtual Affiliates .. 55 Manage Virtual Affiliates .. 57 Virtual affiliate users .. 58 Disable organisation profiles: HQ, Affiliates and Virtual Affiliates .. 58 Disable HQ and Affiliate profiles .. 58 Disable a Virtual affiliate .. 59 Manage Art 57 QPPV and other user contact details .. 59 EMA EudraVigilance Registration Manual EMA/109955/2022 Page 3/69 Manage your contact details .. 60 7. XCOMP Registration process .. 61 XCOMP Registration for organisations with a Production profile .. 61 Managing a XCOMP organisation profile.

5 62 IT system Vendors Registration with XCOMP .. 62 Removal of a Vendor s access from EudraVigilance .. 63 8. Non-Commercial Sponsors Additional Organisation & User management support .. 64 Non-commercial Sponsors managing user access to data .. 64 Non-Commercial sponsor Registration steps .. 66 Annex 1 - EV "base" and "supplementary" roles .. 67 EMA EudraVigilance Registration Manual EMA/109955/2022 Page 4/69 1. Registration overview To set-up a new organisation in EudraVigilance Production or XCOMP (Test system), a series of steps need to be followed (also illustrated in Figure 1): 1. A person within the organisation needs to be chosen as being responsible for managing the organisation and its users in the EudraVigilance Production system.

6 If the organisation is a marketing authorisation holder the primary responsible person will be a Qualified Person for Pharmacovigilance (QPPV); if the organisation is a sponsor/non-commercial sponsor it will be a Responsible Person (RP). 2. Register for an EMA user account in the EMA Account Management portal, if you do not already have one see section 2. 3. Search for your organisation in SPOR Organisation Management System (OMS). If your organisation is not present, it will need to be created see section 4. Submit a request to be registered as the QPPV/RP for the organisation see section 5. Complete organisation Registration details in the EudraVigilance restricted area see section 6.

7 Wait for EMA confirmation that WebTrader or Gateway transmission mode has been set up for your organisation see section Once the QPPV or RP is registered for the Production EudraVigilance system they will automatically also be registered for an XCOMP test account for the same organisation. NOTE: If your organisation is a non-commercial sponsor (NCS) of clinical trials additional support is available for registering and managing users within the organisation see section 8. EMA EudraVigilance Registration Manual EMA/109955/2022 Page 5/69 Figure 1 - Overview of the Registration process with EudraVigilance Production system First User registrationRequest EV QPPV/RPRole in EMA Account Portal Create org in OMS and obtain OMS IDRaise Service Desk ticket with role request id and required supporting documents.

8 Including Gateway connection details if applicableAccess EV restricted area and complete/update fields in the manage your profile sectionNew users can request roles to be approved by RP/QPPV or TD in the EMA Account PortalRequest SPOR unaffiliated role in EMA Account portalRegister with EMA Account Portal Check OMSIs your organisation registered?NoYesWait for up to 5 working days to receive confirmation about Webtrader or Gateway set up EMA EudraVigilance Registration Manual EMA/109955/2022 Page 6/69 2. EMA Account Management portal (IAM) The first step to access EudraVigilance is to be registered with the EMA Account Management portal (IAM).

9 It is likely that you already have an EMA Account Management portal account if you have access to at least one of the following EMA systems: EudraLink, EudraCT Secure, IT Service Desk portal (JIRA), MMSe, MMD, EVDAS, EudraPortal, EudraGMP, Paediatrics, BI Dashboard, EUTCT, CorpGXP, EPITT or PSUR. Users who are already registered and have credentials for one or more of these systems do not need to re-register in the EMA Account Management portal. If you cannot remember your password or user name please see section and section for details on how recover your account. The username and password are the same for all these systems.

10 Users registered with EudraVigilance can already log-in to EudraVigilance with their IAM username/password you can find a shortcut to the EV Human Production restricted area on the EudraVigilance : how to register webpage. There is a validator on the e-mail address to prevent the creation of duplicate EMA IAM accounts during self- Registration . Important note: An individual can only have one IAM user account. A user can, however, have more than one EudraVigilance account associated with their EMA account. In order to have access to more than one organisation, users need to submit separate EudraVigilance base role requests for those organisations.