| About the Day 90 procedure In order to manage the 90 day procedure the Members States operate
a tracking system, Eudratrack, where the RMS updates the product information. All events
during the 90 days period are updated by the RMS and CMS. After a procedure has been
finalised and the product has been accepted at day 90 by the CMS the product will be
transferred, at day 120, from the tracking system into the Product Index This is the date
when,all Member States involved in the procedure should have granted a marketing
authorisation. In some cases, the marketing authorisation in a particular member state
could be delayed until after day 120 and thus the product will not be on the market in
that Member State. Questions in such a case should be put to the marketing authorisation
holder or to that member state�s competent authority. |