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Translation timelines
Centralised procedures – TYPE II VARIATIONS



A. TYPE II, 30-DAY ASSESSMENT


This type of procedure is used for urgent – usually safety related – changes

WDue to the short length of the procedure, it is particularly important to translate the added or changed text components and to transfer them to the national language documents starting on the date of submission…


B. TYPE II, 60-DAY ASSESSMENT


This is the standard procedure

Ideally, the translation process should be started on the day of the submission and only additional changes required by the authorities should be incorporated into the national language documents over the course of the procedure…


C. TYPE II, 90-DAY ASSESSMENT


This procedure is used exclusively for changes or additions to indications.

Ideally for this procedure as well, the translation process should be started on the day the submission…

Centralised procedures – TYPE IB, TYPE IA VARIATIONS



TYPE IB

Type IB variations operate on the principle of ‘tell, wait and do’. That is, after submission of the variation notification, there is a 30-day waiting period until implementation…


Type IA


Type IA variations operate on the principle of ‘do and tell’, either as an immediate notification ‘IAIN’ or as a package of several changes once a year…