BASELINE REQUEST Module 3
sent out requests to Marketing Authorisation Holders in the Centralised
Procedure to provide eCTD baseline for Module 3.
the request is on a voluntary basis, EMA really prefers to have the dossiers
fully in eCTD format, as it facilitates work for many, especially for the
people involved in the procedural activity, assessors and NCAs.
Electronic Active Substance Master Files (eASMF)
The use of
eCTD format for centralised procedure human ASMF submissions will become
mandatory from 1 July 2016.
strategy for the electronic submission of applications aims to improve
efficiency and streamline processes for all stakeholders. ASMF Holders who are
supplying substances for the Centrally Authorised Product (CAP) should submit
their ASMF to the EMA once and not for each application, as previously.
The use of
eCTD will become mandatory for all for Centralised Procedure human ASMF
submissions from 1 July 2016. If an on-going application dossier started in
eCTD format, all subsequent submissions should be in eCTD format in order to
maintain the lifecycle.
has wide experience with eCTD preparation and is fully trained in using
different tools and many years of experience with eCTD preparation and
Centralised Procedures. If you are interested in getting your portfolio into
eCTD and benefit from the Life Cycle Management of eCTD, please contact us at email@example.com