1

2

3

4

Translation Timelines
Variations MRP / DCP / NP


Both the DCP and MRP EU procedures and the strictly national procedures have the same classifications of type IA, IAIN, IB and II as the centralised procedures. The timing of the workflows is also largely the same.

Likewise, the relevant times for the updates to the translated documents are similar in terms of the initial incorporation of changes and their correction/modification during the procedures.

Differences:
The submission is made to the RMS and in parallel to the CMS or for the national procedures to the competent authority.


TYPE II


On the day of submission the translation process to incorporate the changes into the national language documents should be started.....


TYPE IB


Submission of the amended product information in all language versions to the relevant authorities....


RENEWALS


If changes to the product information are suggested as part of the documentation for the marketing authorisation renewal application, they should also be incorporated into the national language versions at the same time.....