Anavex Life Sciences Corp (AVXL)

[Doc328]

Never let a fact get in the way of WGT.

The pertinent section is 2.2 (quotes below from p. 35 and p. 36). So 7 months from request to use the centralised procedure which would mean 6 months from the eligibility request being granted is the earliest for MAA submission (clock starts after this is accepted). The eligibility request is valid 3 years and may be renewed so upper limit for MAA submission is open ended.

EMA recommends providing the eligibility request preferably, at the earliest, 18 months before
submission of the marketing authorisation application (MAA) and, at the latest, 7 months before the
MAA is filed with the EMA, at which point it could be submitted as part of the “letter of intent to

The eligibility to the centralised procedure under optional scope is accepted for a period of 3 years
from the time of CHMP adoption. It is the responsibility of the applicant to monitor the lapse of the
acceptance period. If an extension is intended, the applicant should submit a new eligibility request
under optional scope, and review of eligibility application will take place over 2 consequent CHMP
meetings.

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en.pdf

smh