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|
|Reference number||EMEA/75401/2006 Rev. 2|
|Description||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.
In operation: 06/01/2009-present