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

There 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.

Current effective version

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

Adopted Reference Number: EMEA/75401/2006 Rev. 2 Legal effective date: 01/01/2009

Document history

Overview of comments received on guidance on time allowed for applicants to respond to questions and issues raised during the assessment of new marketing authorisation applications in the centralised procedure

Reference Number: EMEA/545180/2008