Notifications triggered by the system

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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 the CA (positive or negative)

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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)

CI/PS-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.

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-016: PMCF/PMPF is acknowledged by CA

Sponsor owner of the form

When the CA acknowledges receipt of the PMCF/PMPF notification

CI/PS-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

CI/PS-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

CI/PS-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

CI/PS-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