VI.App.1.2. Follow-up of ICSRs by competent authorities in Member States with involvement of marketing authorisation holders
VI.App.1.2. Follow-up of ICSRs by competent authorities in Member States with involvement of marketing authorisation holders
Figure VI.3. Business process map – Follow-up of ICSRs by competent authorities in Member States (NCAs) with involvement of marketing authorisation holders (MAHs). See steps description in Table VI.3.
| No | Step | Description | Responsible Organisation |
| 1 | Start. | Receipt by the MAH of a valid report of suspected adverse reaction related to a medicinal product (ADR report). The clock (D0) for the submission of the valid ICSR starts (see VI.B.7. for day zero definition). Go to step 2. | MAH |
| 2 | Submit ICSR to EV. | Submit the valid ICSR (EEA and non-EEA serious and EEA non-serious) to EudraVigilance (EV) within the relevant time frames (15 or 90 days, as applicable). Non-serious non-EEA ICSRs should not be submitted to EV. Go to step 3. | NCA/MAH |
| 3 | Re-route ICSR to NCA. | Following technical validation and process, the EEA ICSR submitted by the MAH is rerouted from EV to the relevant NCA. Go to step 4. | NCA/MAH |
| 4 | Involve MAH in follow-up? | Is follow-up required for the ICSR with involvement of the MAH?
If Yes, go to step 5. If No, go to step 15. |
NCA/MAH |
| 5 | Follow-up is required. | Member States on whose territory the suspected adverse reaction occurred may involve the marketing authorisation holder in the follow-up of the reports [DIR Art 107a(2)] (see VI.C.2.1. for Member States responsibilities on ICSRs collection). The criteria for involving the MAH include:
Go to step 5.1. |
NCA/MAH |
| 5.1 | Contact MAH to initiate follow-up. | Send an email to the MAH QPPV (or the local contact person where applicable) to request for the missing information.
Identify the reference of the concerned ICSR(s) by using the World Wide Unique Case Identifier(s). Indicate the criteria for the request to involve the MAH in the ICSR(s) follow-up. Indicate the timeframe by when follow-up information should be provided. Go to step 6. |
NCA/MAH |
| 6 | Is follow-up in progress? | Has follow-up of the reporter already been initiated by the MAH?
If Yes, go to step 7. If No go to step 8. |
NCA/MAH |
| 7 | Follow-up is already in progress. | Follow-up has already been initiated by the MAH to request additional information from the reporter. Go to step7.1. | NCA/MAH |
| 7.1 | Inform NCA. | Inform the NCA that follow-up is already in progress. Indicate if the follow-up information cannot be provided within the requested time frame and clarify the time by when the follow-up can be expected.
Provide the reference to the individual case using the World Wide Unique Case Identifier in the communication. Go to step 9. |
NCA/MAH |
| 8 | Follow-up is not in progress. | Follow-up has not yet been initiated by the MAH with the reporter. Go to step 8.1. | NCA/MAH |
| 8.1 | Contact reporter. | Contact the reporter as soon as possible to obtain follow-up information as per the NCA’s request. Go to step 9.
Note: MAH may indicate that the follow-up is performed upon request of a NCA. |
NCA/MAH |
| 9 | Reporter provided information? | Was the requested information provided by the reporter?
If Yes, proceed to step 10. If No, proceed to step 11. |
NCA/MAH |
| 10 | Information obtained from reporter. | The requested information was obtained from the reporter. Go to step 10.1. | NCA/MAH |
| 10.1 | Record follow-up information. | Record the follow-up information in pharmacovigilance database. Go to step 12. | NCA/MAH |
| 11 | No information is obtained. | The reporter did not provide follow-up information. Go to step 11.1. | NCA/MAH |
| 11.1 | Record that no follow-up information was obtained. | Record that the reporter did not provide follow-up information. Go to step 11.2. | NCA/MAH |
| 11.2 | Inform NCA. | Inform the NCA that it was not possible to obtain follow-up information from the reporter.
Provide the reference to the individual case using the World Wide Unique Case Identifier in the communication. Go to step 11.3. |
NCA/MAH |
| 11.3 | End. | End of this follow-up process. | NCA/MAH |
| 12 | Is new information significant? | Determine if the new obtained follow-up information is significant enough (see VI.C.6.2.2.7. Subsection a for examples of significant and non-significant information) to be submitted to EV.
If Yes, proceed to step 13 If No, proceed to step 14. |
NCA/MAH |
| 13 | New information is significant. | The new follow-up information is significant enough to be submitted to EV. Go to step 13.1. | NCA/MAH |
| 13.1 | Submit follow-up ICSR to EV. | Submit the follow-up ICSR to EV within the relevant time frames (15 or 90 days, as applicable). Following technical validation and process, the follow-up ICSR is rerouted from EV to the relevant NCA.
Go to step 13.2. |
NCA/MAH |
| 13.2 | Inform NCA. | Inform the NCA that significant follow-up information was received from the reporter and submitted to EV.
Provide the reference to the individual case using the World Wide Unique Case Identifier in the communication. Go to step 13.3. |
NCA/MAH |
| 13.3 | End. | End of this follow-up process. The follow-up ICSR is now stored in the NCA database. It is available for signal detection and data quality analyses. | NCA/MAH |
| 14 | New information is not significant. | The new follow-up information is not significant enough to be submitted to EV. Go to step 14.1. | NCA/MAH |
| 14.1 | Inform NCA. | Inform the NCA that the new follow-up information received from the reporter is not significant and does not require submission to EV.
Provide the reference to the individual case using the World Wide Unique Case Identifier in the communication. Go to step 14.2. |
NCA/MAH |
| 14.2 | End. | End of this follow-up process. | NCA/MAH |
| 15 | MAH does NOT need to be involved. | There is no need to involve the MAH in the ICSR follow-up. | NCA/MAH |
| 15.1 | End. | Submit the ICSR (EEA and non-EEA serious and EEA non-serious) with the new information to EV within the relevant time frames (15 or 90 days, as applicable). | NCA/MAH |