VI.App.7.4. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders – Duplicate ICSRs submitted to EudraVigilance by different senders and identified by an organisation prior to the detection by the Agency
VI.App.7.4. Duplicate detection in EudraVigilance – Collaboration between the Agency, competent authorities in Member States and marketing authorisation holders – Duplicate ICSRs submitted to EudraVigilance by different senders and identified by an organisation prior to the detection by the Agency
Figure VI.11. 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 different senders and identified by an organisation prior to the detection by the Agency. See steps description in Table VI.17.
Table VI.17. 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 different senders and identified by an organisation prior to the detection by the Agency in EudraVigilance. See process map in Figure VI.11.
| No. | Step | Description | Responsible Organisation |
| Start. | Duplicate ICSRs submitted to EudraVigilance by different senders and identified by an organisation prior to the detection by the Agency
Example: case series described in the medical literature submitted by MAHs to EudraVigilance; these were previously reported by healthcare professionals to a NCA, which submitted the cases to EudraVigilance. Primary source identifiers or patient identifiers were masked and the duplicate detection algorithm in EV did not identify the reports as potential duplicates. |
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| 1 | MAH and NCA send same duplicate case to EV. | Duplicate ICSRs submitted to EudraVigilance by different senders (NCAs and MAHs).
Go to step 2 for duplicate ICSRs submitted by a NCA. Go to step 4 for duplicate ICSRs submitted by a MAH. |
Sender organisation (NCA/MAH) |
| 2 | Re-routing of ICSRs to NCA. | MAHs 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 duplicate detection 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 the duplicate ICSRs after their submission to EudraVigilance by multiple senders as part of its routine duplicate management process. Go to step 3.2. | NCA |
| 3.2 | NCA to inform EMA about duplicates. | The NCA informs EMA by email (duplicates@ema.europa.eu) about the duplicate ICSRs.
Go to step 3.3 for NCA next step. Go to step 6 for EMA next step. |
NCA |
| 3.3 | Follow-up is required. | The NCA manages the duplicate ICSRs locally in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. The reference numbers of the duplicate ICSRs are captured in data element ‘Other case identifiers in previous transmissions’ (ICH-E2B(R2) A.11/ ICHE2B(R3) section C.1.9.1.).
Go to step 3.4 |
NCA |
| 3.4 | End. | ||
| 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 Use73. Go to step 5. | MAH |
| 5 | MAH duplicate detection 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 the duplicate ICSRs after their submission by multiple senders to EudraVigilance as part of its duplicate management process. Go to step 5.2. | MAH |
| 5.2 | MAH to inform EMA about duplicates. | The MAH informs EMA by email (duplicates@ema.europa.eu) about the duplicate ICSRs.
Go to step 5.3 for MAH next step. Go to step 6 for EMA next step. |
MAH |
| 5.3 | MAH to administrate duplicates locally. | The MAH manages duplicate ICSRs locally in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports.
The reference numbers of the duplicate ICSRs are captured in data element ‘Other case identifiers in previous transmissions’ (ICH-E2B(R2) A.11/ ICHE2B(R3) section C.1.9.1.). Go to step 5.4. |
MAH |
| 5.4 | End. | MAH | |
| 6 | EMA to merge duplicate ICSRs and record outcome. | EMA merges duplicate ICSRs in EudraVigilance in line with the guidance provided in GVP Module VI Addendum I – Duplicate management of adverse reaction reports. Go to step 6.1. | EMA |
| 6.1 | EMA to inform senders about master case. | EMA informs the sender organisations (MAH/NCA) about the outcome of the duplicate management (creation of master case) to allow them to take action where necessary 74, 75, 76 . Go to step 6.2. | EMA |
| 6.2 | NCA/MAH to administrate duplicates locally. | Senders’ organisations (NCA and MAH) of the ICSRs identified as duplicate administrate the information about the master case in their database (reference number of the master case created by EMA to be captured in ICH E2B(R2) A.1.11 / E2B(R3) C.1.9.1: ‘Other case identifiers in previous transmissions’). The updated version of the ICSRs should not be resubmitted to EV. Go to step 6.3. | Sender organisations (MAH/NCA) |
| 6.3 | End. |