Transcription of Timetable: Initial (full) marketing authorisation …
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Timetable: Initial (full) marketing authorisation …
European Medicines Agency, 2017. Reproduction is authorised provided the source is 1 / 13 EMA/119185/2015 Medicines Evaluation The timetables in this document may be subject to revisionInitial ( full ) marketing authorisation application assessment timetablesAssessment of Initial submission (120-day timetable)Assessment of responses to List of Questions (60-day timetable after clock-stop for submission of responses)Assessment of responses to List of Outstanding Issues (30-day timetable after clock-stop for responses)Assessment of responses to List of Outstanding Issues (30-day timetable after immediate responses)Assessment of Outstanding Issues following Oral Explanation (30-day timetable)31 October 201730 Churchill Place Canary Wharf London E14 5EU United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +
The timetables in this document may be subject to revision Initial (Full) Marketing Authorisation application assessment timetables: Assessment of initial submission (120-day timetable)
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