eCTD Format Mandatory for EU National Procedures

23 janvier 2019


After CP, DCP/MRP Procedures, and according to the eSubmissions Roadmap Timelines, eCTD format is now mandatory for all National Procedures in Europe CP Procedure -> eCTD Mandatory from 2010 DCP / MRP Procedures– all regulatory activities -> eCTD mandatory from…

Conversion of centrally authorized products into national UK Marketing authorisations in case of No Deal Brexit

4 décembre 2018


MHRA has sent to Marketing Authorization Holder (MAH) a guidance outlining requirements for submitting baseline information on your product in case of Brexit No Deal Scenario . As MAH, you should be prepared, and BlueReg can provide regulatory and publishing…

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