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Translation timelines
Centralised procedure (CP) – normal duration of the procedure



THE PROCEDURE NORMALLY LASTS 180 OR 210 DAYS.


Day of submission
The applicant should inform mpü about the submission and send in the documents to be translated. This enables reliable planning of the process and resources. If it is possible and feasible, the translations can be started at this stage.

Day 80
The applicant submits the first version of the assessment report from the rapporteur/co-rapporteur. Any requirements to make changes to the SmPC, package leaflet or labelling should be forwarded to mpü. The translations should be carried out from day 80 at the latest, taking any comments in the assessment report into account.

Day 120, start of the clock-off phase
The applicant receives the list of questions (LoQ). If there have been any requirements to make changes to the SmPC, package leaflet or labelling, the applicant should inform mpü. When submitting the response package, the applicant should forward the changed source text.

Day 180 or 210, if outstanding issues still have to be resolved.
Forwarding of the Positive Opinion to the applicant. After the Positive Opinion, only final corrections should now be made.


Centralised procedure (CP) – accelerated procedure



THE PROCEDURE LASTS 90 DAYS PLUS 30 DAYS FOR REVIEWING A RESPONSE PACKAGE


Day of submission
The applicant should inform mpü about the submission and send in the documents to be translated. This enables reliable planning of the process and resources. If it is possible and feasible, the translations can be started at this stage.

Day 60
The applicant submits the first version of the assessment report from the rapporteur/co-rapporteur. Any requirements to make changes to the SmPC, package leaflet or labelling should be forwarded to mpü. The translations should be carried out from day 60 at the latest, taking any comments in the assessment report into account.

Day 90, start of the clock-off phase
The applicant receives the list of questions (LoQ). If there have been any requirements to make changes to the SmPC, package leaflet or labelling, the applicant should inform mpü. When submitting the response package, the applicant should forward the changed source text.

Day 120
Forwarding of the Positive Opinion to the applicant. After the Positive Opinion, only final corrections should now be made.