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For Marketing Authorisation
Found 2 free book(s)
EudraVigilance User Manual Marketing Authorisation …
www.ema.europa.euSection 6 updated to reflect the marketing authorisation status within the active substance grouping reports outputs . Section 8.3.3 updated to clarify the ‘hide columns’ functionality. Section 9.1 updated to clarify the use of the eRMR in relation to the frequency of monitoring . Section 9.3.1 created to describe the considerations
Timetable: Initial (Full) Marketing Authorisation ...
www.ema.europa.eu(¬) This timetable is not applicable to Advanced Therapy Medicinal Products (ATMPs); for these the applicant should refer to the timetable for initial …