VI. Appendix 6 Data quality monitoring of ICSRs transmitted electronically
Location:
VI. Appendix 6
Figure VI.7. Business process map – Review of quality and integrity of ICSRs by the Agency in collaboration with competent authorities in Member States (NCAs) and marketing authorisation holders (MAHs). See steps description in Table VI.13.
Table VI.13. Process description – Review of quality and integrity of ICSRs by the Agency in collaboration with competent authorities in Member States (NCAs) and marketing authorisation holders (MAHs). See process map in Figure VI.7.
| No. | Step | Description | Responsible Organisation |
|---|---|---|---|
| 1 | Start. | Receipt of ICSRs in EudraVigilance (EV) from sender organisations (NCAs and MAHs) with obligations for the submission of ICSRs related to medicinal products authorised in the EEA. Go to step 2. | EMA |
| 2 | ICSRs quality and integrity review by EMA. | A review of the quality, integrity, use of terminologies, and compliance with submission time frames is performed in accordance with the applicable SOP and WINs on the ICSRs submitted to EV. Go to step 3. | EMA |
| 3 | EV quality review report sent to organisation. | A draft report summarising the outcome of the quality review is sent by e-mail to the concerned sending organisation (NCA head of Pharmacovigilance Department or MAH EU QPPV). Go to step 4. | EMA |
| 4 | Need for corrective actions? | Are corrective actions required by the organisation being reviewed (NCA/MAH)?
If Yes, go to step 5. If No, go to step 6. |
Organisation being reviewed (NCA/MAH) |
| 5 | Corrective actions required. | Corrective actions are required by organisation being reviewed. Go to step 5.1. | Organisation being reviewed (NCA/MAH) |
| 5.1 | Review and comment. | Review the draft quality report and provide comments to EMA within the requested time frame. Go to step 7.. | Organisation being reviewed (NCA/MAH) |
| 6 | No corrective actions required by sender. | No corrective actions are required following the quality review of the ICSRs submitted by the concerned organisation. Go to step 6.1. | Organisation being reviewed (NCA/MAH) |
| 6.1 | Record outcome of review. | Record the outcome of the quality review report. Go to step 6.2. | Organisation being reviewed (NCA/MAH) |
| 6.2 | End. | End of the quality review procedure. | EMA/ Organisation being reviewed (NCA/MAH) |
| 7 | Is meeting required? | Is there a need to organise a meeting between the reviewed organisation and EMA?
If Yes, go to step 8. If No, go to step 9. |
EMA/ Organisation being reviewed (NCA/MAH) |
| 8 | Meeting is required by EMA or sender. | A review meeting is requested by the sender organisation or is proposed by EMA. Go to step 8.1. | EMA/ Organisation being reviewed (NCA/MAH) |
| 8.1 | Meeting organised by EMA. | A meeting is organised (via TC or face-to-face). Go to step 8.2. | NCA/MAH |
| 8.2 | Meeting minutes drafted by sender. | Agreed actions and outcome of discussions to be summarised in draft meeting minutes. Go to step 8.3. | Organisation being reviewed (NCA/MAH) |
| 8.3 | Minutes approved by EMA and sender. | Approve the meeting minutes as final. Go to step 8.4. | EMA/ Organisation being reviewed (NCA/MAH) |
| 8.4 | Final minutes recorded by EMA and sender. | Record the final meeting minutes. Go to step 10. | EMA/ Organisation being reviewed (NCA/MAH) |
| 9 | A meeting is not required by EMA or sender. | No review meeting is required (requested by the sender organisation or proposed by EMA). Go to step 10. | EMA/ Organisation being reviewed (NCA/MAH) |
| 10 | Corrective actions agreed by sender. | The corrective actions and time frames are agreed by the sending organisation being reviewed. The agreement is to be reflected on the basis of the final quality review report, which is to be recorded. Go to step 10.1. | Organisation being reviewed (NCA/MAH) |
| 10.1 | Corrective actions implemented by sender. | The sending organisation should implement the corrective actions in accordance with the agreed methods and time frames. Go to step 10.2. | Organisation being reviewed (NCA/MAH) |
| 10.2 | Inform EMA about outcome. | The sending organisation informs EMA when the corrective actions have been implemented in line with the final quality review report. Go to step 10.3. | Organisation being reviewed (NCA/MAH) |
| 10.3 | EMA record notification. | The notification of implementation of the corrective actions in line with the final quality review report is recorded by the Agency. Go to step 11. | EMA |
| 11 | Are corrective actions implemented? | Have the agreed corrective actions been implemented by the sending organisation? EMA monitors and checks if the agreed corrective actions have been implemented.
If No, go to step 12. If Yes, go to step 13. |
EMA |
| 12 | Corrective actions not implemented by sender. | The agreed corrective actions have not been implemented by the sending organisation. Go to step 12.1 | Organisation being reviewed (NCA/MAH) |
| 12.1 | Reminder sent by EMA to reviewed organisation. | Send reminder to the sending organisation being reviewed to implement corrective actions. Go back to step 10.1. | EMA |
| 13 | Corrective actions implemented. | The sending organisation informs EMA when the corrective actions have been implemented in line with the final quality review report. Go to step 10.3. | Organisation being reviewed (NCA/MAH) |
| 13.1 | End. | The ICSRs quality review procedure ends. | EMA/ Organisation being reviewed (NCA/MAH) |