On the eSubmission website a Q&A document has been published on how to handle eCTD for Active Substance Master Files (ASMFs).
For now the Q&A document only consists of one question and answer about which eCTD sequence(s) need to be submitted for an ASMF in different procedures. It is advised that for an ASMF there should only be one eCTD lifecycle. This implies that the initial submission of the ASMF submitted in relation to the first marketing authorisation or variation procedure will be sequence 0000. Each subsequent procedure will be the next sequence in this lifecycle.
In case one ASMF is used for different procedures and involved countries, the life-cycle should continue within the same eCTD dossier. In the sequence tracking table should detail to which countries which sequence has been submitted and when.
Asphalion is supporting a large number of ASMF submissions. If you are interested in support, please contact us at: [email protected]