eCTD Format Mandatory for EU National Procedures
23 janvier 2019
News
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
News
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…
