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 |