If you ever wonder which the different user access categories are when setting up users in EVWEB and the EMA User Access Portal then this article may be for you.
It is not easy to find but EMA has issued a guidance that can help you with the details of registering users and access roles with the portal. If you want to go through the details then use this link which will download the manual from EMA. If you just want to see the categories then they are shown in the table below:
| EV Production Base Roles | |
|
EV Human NCA Responsible |
Request this role, if you work for an NCA/Regulatory Agency and you are the main responsible for the Pharmacovigilance in your organisation profile. This role allows you to grant and revoke access to users and manage the organisation hierarchy. This role grants you full access. |
|
EV Human MAH EU QPPV |
Request this role, if you work for a MAH and you are the main QPPV. This role allows you to grant and revoke access to users and manage the organisation hierarchy. This role grants you full access. |
|
EV Human CS/NCS Responsible |
Request this role, if you work for a Commercial Sponsor or a Non- Commercial Sponsor and you are the main responsible for the Pharmacovigilance in your organisation profile.
This role allows you to grant and revoke access to users and manage the organisation hierarchy. This role grants you full access. |
|
EV Human NCA Trusted Deputy |
Request this role, if you work for an NCA/Regulatory Agency and you are supporting the main responsible for Pharmacovigilance in the administrative tasks.
This role allows you to grant and revoke access to users and manage the organisation hierarchy. This role grants you full access. Please note, this role will be rejected, if your organisation does not have an EV NCA Responsible. |
|
EV Human MAH/CS/NCS Trusted Deputy |
Request this role, if you work for an MAH, Commercial Sponsor or Non Commercial Sponsor and you are supporting the main responsible for Pharmacovigilance in the administrative tasks.
This role allows you to grant and revoke access to users and manage the organisation hierarchy. This role grants you full access. Please note, this role will be rejected, if your organisation does not have an EV MAH EU QPPV or an EV CS/NCS Responsible. |
| EV Human NCA/MAH/CS/NCS
Browse ICSR |
Request this role, if you need only access to ICSR messages. Please note, this role will be rejected, if your organisation does not have an EV Responsible or EV EU QPPV. |
| EV Human NCA/MAH/CS/NCS ICSR
Browse & Send |
Request this role if you need to perform queries, create and send ICSRs, receive safety messages, store the safety messages locally and generate acknowledgement messages. |
| EV Human NCA/MAH/CS/NCS
Browse MPR |
Request this role, if you need only access to browse Medicinal Products in the XEVMPD. |
|
EV Human MAH/CS/NCS Browse & Send MPR |
Request this role, if you work for an MAH, Commercial Sponsor or Non Commercial Sponsor and you need only functionalities related to the Medicinal Products: create queries, create and send extended Medicinal Products Reports or generate acknowledgement messages. |
|
EV Human MAH/CS/NCS Browse and Send ICSR and MPR |
Request this role, if you work for an MAH, Commercial Sponsor or Non Commercial Sponsor and you need full functionalities related to the Medicinal Products and ICSRs: perform queries, create and send extended Medicinal Products Reports, create and send ICSRs (including L2A access to ICSRs, applicable only to MAHs and based on the active substance for medicinal products for which the MAH holds a marketing authorisation). |
|
EV Human NCA/MAH/CS/NCS Browse ICSR and MPR |
Request this role, if you need basic functionalities related to the Medicinal Products and ICSRs (including L2A access to ICSRs, applicable only to MAHs and based on the active substance for medicinal products for which the MAH holds a marketing authorisation). |
|
EV Human Contributor |
Request this role only, if you need access to EV on behalf of a Virtual Affiliate. You will only be able to access EV, after a Responsible or Trusted Deputy has assigned you adequate access through the EV Restricted Area.
Please note this role is limited to a Virtual Affiliate only and for this reason, you won’t be able to access your organisation’s HQ profile in EV; if you need access to it, you should liaise with your organisation’s QPPV/RP or trusted deputy to change in your access permissions. |
| EV Production Supplementary Roles
Note: EVDAS roles are only for NCA and MAH HQ profile users |
|
|
EV Human MAH Additional QPPV |
Request this role only, if you are NOT the EU QPPV user for that profile, work for an MAH organisation and you need a QPPV Code.
Please note that you can only request this after you have been granted a base role (i.e. Browse ICSR, Browse and Send ICSR and MPR). |
|
EV Human L2B Access |
Request this role only, if you are authorised to visualize personal data of the patients by your QPPV.
Please note that you can only request this, after you have been granted a base role (i.e. Browse ICSR, Browse and Send ICSR and MPR etc). |
|
EVDAS Human NCA Administrator |
Request this role only, if you work for an NCA/Regulatory Authority and need browse access to EVDAS.
Please note that you can only request this, after you have been granted a base role (i.e. Browse ICSR, Browse and Send ICSR and MPR etc). |
|
EVDAS Human NCA Scientific |
Request this role only, if you work for an NCA/Regulatory Authority and need access to ICSR forms.
Please note that you can only request this, after you have been granted a base role (i.e. Browse ICSR, Browse and Send ICSR and MPR etc). |
| EV XCOMP Base Roles | |
|
EV Human XCOMP User |
You should request this role if you want to access XCOMP environment. Before requesting this role a Responsible person for your organisation must be appointed. |
|
EV Human XCOMP Vendor Responsible person |
A responsible person from an IT Vendor of a Pharmacovigilance system should request this role in order to register their organisation in EV XCOMP. No user access permissions for XCOMP are given with this role. |
