VI.App.7.1. 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 Agency
Figure VI.8. 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 Agency. See steps description in Table VI.14.
Table VI.14. Process description – 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 Agency. See process map in Figure VI.8.
| No. | Step | Description | Responsible Organisation |
| Start. | Duplicate ICSRs submitted to EudraVigilance by the same sender and identified by the Agency. | ||
| 1 | EudraVigilance DD algorithm. | A duplicate detection algorithm is operated in EudraVigilance to detect potential duplicate ICSRs. Go to step 2. | EMA |
| 2 | EMA DD Management Process. | The potential duplicate ICSRs identified by the EudraVigilance duplicate detection algorithm are reviewed by EMA in accordance with the applicable SOP and WINs. Go to step 2.1. | EMA |
| 2.1 | Are duplicate ICSRs confirmed by EMA? | Are the duplicate ICSRs identified by the EudraVigilance duplicate detection algorithm confirmed by EMA?
If Yes, proceed to step 3. If No, proceed to step 4. |
EMA |
| 3 | Are the duplicate ICSRs from the same sender organisation? | Are the confirmed duplicate ICSRs from the same sender organisation?
If Yes, proceed to step 5. If No, proceed according to the business process map related to duplicate detection of ICSRs from different senders outlined in Figure VI.9 and Table VI.15 for the management of duplicate ICSRs submitted to EudraVigilance by different senders and identified by the Agency. |
EMA |
| 4 | No confirmed duplicate ICSRs. | As a result of the duplicate detection management process by EMA, it is confirmed that the individual cases are not duplicate ICSRs. Go to step 4.1. | EMA |
| 4.1 | EMA to record outcome of duplicate management. | The outcome of the duplicate detection management process is recorded in accordance with the applicable SOP and WINs. Go to step 4.2. | EMA |
| 4.2 | End. | EMA | |
| 5 | EMA to contact ICSRs sender. | EMA contacts the sender organisation (MAH/NCA) to inform about the potential duplicate ICSRs identified in EudraVigilance. Go to step 6. | EMA |
| 6 | Are duplicates confirmed by sender? | Does the sender organisation confirm EMA assessment of the duplicate ICSRs?
If Yes, proceed to step 7 for sender next step and to step 8 for EMA next step. If No, proceed to step 8 for EMA next step. |
EMA/ Sender organisation (MAH/NCA) |
| 7 | Sender to update/nullify cases. | The sender organisation updates/nullifies the duplicate ICSRs in their pharmacovigilance database in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. Go to step 7.1. | Sender organisation (MAH/NCA) |
| 7.1 | Updated ICSRs submitted to EV. | The sender organisation submits the updated ICSRs/nullification reports to EudraVigilance in accordance with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. Go to step 7.2. | Sender organisation (MAH/NCA) |
| 7.2 | End. | Sender organisation (MAH/NCA) | |
| 8 | EMA to record/monitor duplicate management outcome. | If the ICSRs are not confirmed as duplicates by the sender, EMA records the outcome of the duplicate management. Go to step 8.1.
If the sender confirms the duplicate ICSRs, EMA monitors that the sender has addressed them by submitting updated/nullified ICSRs to EV. Go to step 8.1. |
EMA |
| 8.1 | Are the duplicate ICSRs addressed? | Have the duplicate ICSRs been addressed by the sender organisation?
If Yes, process to step 8.2. If No, process back to step 5. |
EMA |
| 8.2 | End. |