VI.App.7.3. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders – Duplicate ICSRs submitted to EudraVigilance by the same sender and identified by the sender organisation prior to the detection by the Agency
VI.App.7.3. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders – Duplicate ICSRs submitted to EudraVigilance by the same sender and identified by the sender organisation prior to the detection by the Agency
Figure VI.10. Business process map – Duplicate Detection (DD) in EudraVigilance – Collaboration between the Agency, competent authorities in Member States (NCAs) and marketing authorisation holders (MAHs) – Duplicate ICSRs submitted to EudraVigilance by the same sender and identified by the sender organisation prior to the detection by the Agency. See steps description in Table VI.16.
Table VI.16. Process description – Duplicate Detection (DD) in EudraVigilance – Collaboration between the Agency, Member States and MAHs – Duplicate ICSRs submitted to EudraVigilance by the same sender and identified by the sender organisation prior to the detection by the Agency. See process map in Figure VI.10.
| No. | Step | Description | Responsible Organisation |
| Start. | Duplicate ICSRs submitted to EudraVigilance by the same sender (NCA or MAH) and identified by the sender organisation prior to the detection by the Agency. | ||
| 1 | Duplicate ICSRs submitted to EV. | Duplicate ICSRs are submitted to EudraVigilance (EV) by the same sender (MAH or NCA).
Go to step 2 for duplicate ICSRs submitted by a NCA. Go to step 4 for duplicate ICSRs submitted by a MAH. |
Sender organisation (MAH/NCA) |
| 2 | Re-routing of ICSRs to NCA. | EEA ICSRs are rerouted from EudraVigilance to the NCA in accordance with VI.C.4. and the rerouting principles described in the EU Individual Case Safety Report (ICSR) Implementation Guide (EMA/51938/2013). Go to step 3. | EMA/ EudraVigilance |
| 3 | NCA DD and management process. | A routine duplicate detection process is performed regularly by the NCA in its pharmacovigilance database. Go to step 3.1. | NCA |
| 3.1 | NCA detects duplicates sent to EV. | The NCA identifies duplicate ICSRs of its own cases after their submission to EudraVigilance as part of its routine duplicate management process. Go to step 3.2. | NCA |
| 3.2 | NCA to update/ nullify ICSRs and send update to EV. | The NCA reviews and updates/nullifies its own duplicate ICSRs and submits the updated ICSRs/ nullification ICSRs to EudraVigilance in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. Go to step 3.3. | NCA |
| 3.3 | End. | NCA | |
| 4 | Access to ICSRs in EudraVigilance by MAHs. | ICSRs are made accessible to MAHs in line with the EudraVigilance Access Policy for Medicines for Human Use72 . Go to step 5. | MAH |
| 5 | MAH DD and management Process | A routine duplicate detection process is performed regularly by the MAH in its pharmacovigilance database. Go to step 5.1. | MAH |
| 5.1 | MAH detects duplicates sent to EV. | The MAH identifies duplicate ICSRs of its own cases after their submission to EudraVigilance as part of its routine duplicate management process. Go to step 5.2. | MAH |
| 5.2 | MAH to update/ nullify ICSRs and send update to EV. | The MAH reviews and updates/nullifies its own duplicate ICSRs and submits the updated ICSRs/ nullification ICSRs to EudraVigilance in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. Go to step 5.3. | MAH |
| 5.3 | End. | MAH |