Stakeholders

Table Column Head

The report type

The open level

Open mode

Open way

Whether authorization is required to access data

EC, EMA and medicines regulatory authorities in EEA member states

EVPM2

reports

Level 3

Proactive

EVWEB3, EVDAS4

The authorized personnel of EC, EMA and Drug regulatory agencies of the Member States

Healthcare professionals and the public

Spontaneous reports

Level 1

Proactive

ADR Web Portal

No request

MAH

Spontaneous reports

Level 1

Proactive

ADR Web Portal

No request

EVPM reports

Level 1

Proactive

EVWEB, EVDAS

The EU Pharmacovigilance Authorizer (headquarters level) or the EU Pharmacovigilance Authorizer is strictly responsible for the appointed agents and authorized personnel

Level 2A

Proactive

Level 3*5

Proactive

Level 2B

Reactive

Apply to the EMA

Access may only be made by the EU Pharmacovigilance Authorizer (headquarters level) or by agents and authorized personnel appointed under the strict responsibility of the EU Pharmacovigilance Authorizer after the submission of the request and the undertaking of confidentiality

Academia

Spontaneous report

Level 1

Proactive

ADR Web Portal

No request

EVPM reports

Level 2A

Reactive

Apply to the EMA

After the research application is submitted and the letter of confidentiality is signed, the personnel designated by the research institution can visit the site

WHO

Spontaneous report

Level 1

Proactive

ADR Web Portal

No request

EVPM reports

Level 2C

Proactive

The API of WHO-UMC and EMA

Authorized personnel from the World Health Organization (WHO) Monitoring Centre in Uppsala

Medicines regulatory authorities in third-country

Spontaneous report

Level 1

Proactive

ADR Web Portal

No request

EVPM reports

Level 2C

Reactive

Apply to the EMA

Person appointed by the drug regulatory authority of the third-country