Time allowed for applicants to respond to questions and issues raised during the assessment of new marketing authorisation applications in the centralised procedure

Current effective version

PDF iconAdopted guideline

Reference numberEMEA/75401/2006 Rev. 2
DescriptionThere is clearly laid out in the Legislation a timetable of 210 days1 for the evaluation of centralised 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. This is important to ensure that the Committee for Medicinal Products for Human Use (CHMP) is consistent in dealing
with applications; therefore a policy applicable to the evaluation of all new MAAs has been established.

Document history

Revision 2
Current version

PDF iconAdopted guideline

PDF iconOverview of comments

In operation: 06/01/2009-present

Published: 09/12/2008

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