Notifications triggered by the system
Identifier and subject of the EUDAMED notification | Recipient(s) | Triggered |
---|---|---|
CIPS-001: Submission of CI/PS application - one country | CA selected in the National information section - Local Competent Authority field | At submission of the first version of the form |
CIPS-002: Submission of PMCF/PMPF notification - including sponsor validation information | CA selected in the National information section - Local Competent Authority field | At submission of the first version of the form |
CIPS-023: Submission of pre-existing CI/PS application - one country | CA selected in the National information section - Local Competent Authority field | At submission of the first version of the form for a CI/PS that was allowed to start before EUDAMED CI/PS is available |
CIPS-024: Submission of pre-existing PMCF/PMPF notification | CA selected in the National information section - Local Competent Authority field | At submission of the first version of the form for a PMCF/PMPF that was allowed to start before EUDAMED CI/PS is available |
CIPS-026: pre-existing CI/PS application or PMCF/PMPF notification: sponsor submitted response to rejection | CA selected in the National information section - Local Competent Authority field | At submission of a response by the sponsor to the rejection of a CI/PS or PMCF/PMPF that was allowed to start before EUDAMED CI/PS is available |
CIPS-042: CI/PS application - one country: outcome of validation process (generic) | Sponsor owner of the form and CA actor selected in the National information section - Local Competent Authority field | At submission of the validation decision by te CA (positive or negative) |
CIPS-025: registration of pre-existing CI/PS application or PMCF/PMPF notification was assessed by CA | Sponsor owner of the form | At submission of the CA assessment of a CI/PS or PMCF/PMPF that was allowed to start before EUDAMED CI/PS is available |
CIPS-051: Submission for additional country(ies) - CI/PS one country | All CAs to whom another CI/PS application with the same EU SIN has already been submitted | At submission of a new application for additional countries for the same EU SIN |
CIPS-053: Submission for additional country - PMCF/PMPF notification | All CAs to whom another PMCF/PMPF notification with the same EU SIN has already been submitted | At submission of a new notification for additional countries for the same EU SIN |
CIPS-022: Sponsor submits normal update to CI/PS application or PMCF/PMPF notification | CA selected in the National information section - Local Competent Authority field | When the sponsor submits a new version of the application/notification that is not a substantial modification |
CIPS-005: CA extends deadline for validation of CI/PS application - one country | Sponsor owner of the form | When the CA extends the period for validation |
CIPS-006: CA extends deadline for sponsor in CI/PS application - one country | Sponsor owner of the form | When the CA extends the period for the sponsor to react to the initial rejection of the application |
CIPS-007: CI/PS application - one country: sponsor submitted response to rejection | CA selected in the National information section - Local Competent Authority field | When the sponsor submits a response to the initial rejection of the application |
CIPS-009: The application is lapsed (no sponsor response before deadline) | Sponsor owner of the form and CA actor selected in the National information section - Local Competent Authority field | When the sponsor did not submit a response to the initial rejection of the application before the deadline expired |
CIPS-010: CI/PS application - one country: authorisation outcome | Sponsor owner of the form and CA actor selected in the National information section - Local Competent Authority field | At submission of the authorisation decision by the CA (positive or negative) |
CIPS-011: CI/PS application - one country: authorisation refused (corrective measure) | All CAs with CI/PS responsibilities and EC actor | When the CA refuses authorisation of a CI/PS application - one country. This is considered to be a corrective measure and is therefore communicated to all CAs and the EC. |
CIPS-012: Request additional information during authorisation - one country | Sponsor owner of the form and CA actor selected in the National information section - Local Competent Authority field | When the CA submits a request for additional information during the authorisation process |
CIPS-013: Provide additional information during authorisation - one country | CA selected in the National information section - Local Competent Authority field | When the sponsor submits a response to the request for additional information from the CA |
CIPS-014: CA extends deadline for authorisation of CI/PS application - one country | Sponsor owner of the form | When the CA extends the period for authorisation |
CIPS-015: PMCF/PMPF - no reaction from CA | Sponsor owner of the form | When the CA does not submit a response to the PMCF/PMPF notification after 30 days |
CIPS-016: PMCF/PMPF is acknowledged by CA | Sponsor owner of the form | When the CA acknowledges receipt of the PMCF/PMPF notification |
CIPS-027: CI/PS application - one country is withdrawn by sponsor | All CAs with CI/PS responsibilities and EC actor | When the sponsor withdraws the CI/PS application |
CIPS-029: PMCF/PMPF notification is withdrawn by sponsor | All CAs with CI/PS responsibilities and EC actor | When the sponsor withdraws the PMCF/PMPF notification |
CIPS-018: Sponsor defined (re)start date for a participating country | CA selected in the National information section - Local Competent Authority field | When the sponsor submitted the start date or the restart date of a CI/PS or PMCF/PMPF |
CIPS-008: Sponsor actor data ready for publication | Sponsor for which the actor data was 'validated' implicitly | When the CA positively validates a CI/PS application or acknowledges receipt of a PMCF/PMPF notification |