EMEA: Adopted guideline, time allowed for Applicants to respond to Questions and Issues raised during the assessment of new Marketing Authorisation Applications in the Centralised Procedure

EMEA:
Adopted guideline, time allowed for Applicants to respond to Questions and Issues raised during the assessment of new Marketing Authorisation Applications in the Centralised Procedure
(Adopted by CHMP December 2008) (Rev.2)

There is clearly laid out in the Legislation a timetable of 210 days1 for the evaluation of centralized marketing authorisation applications (MAAs). Clear “rules” are needed as to how long applicants may take to respond to questions/issues raised during the evaluation of such MAAs.