Deadlines applying to the CI/PS application – one country
Key date/event | Process description | Deadline | Possibility of extension? | Period can be suspended? |
|---|---|---|---|---|
Submission date | Sponsor submits CI/PS application | |||
Validation date | Time for validation decision by CA | 10 days of submission date (FS-CIPS-003.05) | Yes, + 5 days (LR-CIPS-025) | |
(in case of negative validation decision) | Time for sponsor to provide comments or complete application | 10 days of negative validation decision | Yes, + 20 days | |
Validation date | Time for CA to provide validation decision after additional comments or completion of application by sponsor | 5 days of sponsor’s feedback | Yes, + 5 days (LR-CIPS-025) | |
Authorisation date | Time for authorisation decision (assessment) by CA | 45 days of validation date | Yes, + 20 days or + 50 days if Class IIb/C or Class III/D | Yes, while waiting for response sponsor: additional comment or complete application |