Module 12 2019

eCTD for variations

In case of rejected/withdrawn variations, a consolidated sequence should be submitted, according to EU guidance

Sequence 0006

Latest approved SmPC with 1 indication

Sequence 0014

Variation 10 to add a 2nd indication

Variation 10

not accepted

Sequence 0015

Replace document in sequence 0014 with the content of document from sequence 0006.

The Organisation for Professionals in Regulatory Affairs