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Steady_T

07/29/24 6:44 PM

#465589 RE: Hosai #465585

Eligibility request is the first step according to the EMU guidelines.

Steps involved in obtaining an
EU marketing authorisation
1. Submission of eligibility request.
(At the earliest 18 months and at the latest
7 months in advance of submission.)
2. Notification of intention to submit
an application.
(Approx. 7 months in advance of submission.)
3. Appointment of rapporteurs.
(Approx. 7 months in advance of submission.)
4. Pre-submission meeting.
(Approx. 7 months in advance of submission.)
5. Submission of the application.
6. Scientific evaluation.
(210 days of assessment.)
7. CHMP scientific opinion.
8. European Commission decision on
the marketing authorisation.