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Translation timelines
Decentralised procedure (DCP)



THE PROCEDURE CAN LAST 105, 150 OR 210 DAYS DEPENDING ON THE CONSENSUS BUILDING OF THE NATIONAL AUTHORITIES



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.

Day 70
The Reference Member State (RMS) distributes the preliminary assessment report (PAR) to the Concerned Member States (CMS) and the applicant. The translations should be carried out from day 70 at the latest, taking any comments in the PAR into account.

Day 105

The deficiency statements from the Member States are made available to the applicant. » Start of the clock-off phase If the response package contains any changes to be made to the SmPC, package leaflet or labelling, the modified documents should be forwarded to mpü along with the response package.

Day 150
If consensus has been reached between all MS, the RMS grants the DC approval. Once the DC approval has been granted, only final corrections should now be made. If any points are still not clarified, the RMS informs the applicant. Another phase of discussions follows.

Day 210
Normally, consensus is reached by day 210 at the latest and the RMS grants the DC approval. Once the DC approval has been granted, only final corrections should now be made.