EMA updates Timelines of eAFs for Variations for Medicinal Products for Human Use

Recommendation

17/18 September 2024

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In future, submissions of variation notifications for medicinal products for human use are to be made exclusively via the electronic application forms (eAFs). The timelines for the full implementation of these systems have now been updated again and are listed on the EMA website in the PLM Portal (Product Lifecycle Management Portal).

Under the heading "What's New in PLM?" the newly defined timelines are shown and illustrated in the two-page document made available there. The mandatory use of electronic application forms is set for the end of the third quarter or the beginning of the fourth quarter of 2024 after a six-month transition period.

Please see the EMA website for the updated timelines and further information on the implementation of the electronic submission of variation notifications.