Questions and answers on signal management : update

14 janvier 2019

BlueRegWatch

This revision includes:
- Information on the implementation of the legal requirement for MAHs to monitor EudraVigilance data and inform EMA and national competent authorities of validated signals, with reference to the ongoing pilot (questions 5 and 6);
- Update of the requirements for the submission of additional data (question 11);
- Clarification of the variation category (question 15);
- Minor alignments with revision 1 of GVP Module IX and editorial improvements throughout

BlueRegWatch

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