eCTD/VNeeS

eCTD/VNeeS will also be mandatory for purely national applications

Since 2003 eCTD has been available in EU, US and Japan as standard for electronic submission of dossiers for human medicines. To profit from benefits of this format, such as in dossier management, lifecycle management and quality assurance, and to push forward harmonization, the stepwise implementation of the mandatory submission in eCTD format is planned.

 

According to the eSubmission roadmap of EMA and HMA (Heads of Medicines Agencies) new applications in the Decentralised Procedure (DCP) need to be filed in eCTD format (electronic Common Technical Document) from 01.07.2015 and new applications in the Mutual Recognition Procedure (MRP) from 01.01.2017. By 01.01.2018 at the latest all dossiers/dossier parts in EU variation and renewal procedures must be submitted in eCTD format.

 

In February 2017 an updated version of the eSubmission-Roadmap was published, setting implementation dates for mandatory use of eCTD/VNeeS format in purely national new applications (01.07.2018) respectively for purely national variation and renewal applications (01.01.2019). BASG adopts these implementation dates.

 

BASG recommends submitting at least module 3 as baseline submission separately before variation or renewal applications (according to Harmonised Technical Guidance for eCTD Submissions in the EU).

 

National new applications for registration of homeopathic and pharmacy-owned medicinal products including their lifecycle are excluded from these provisions. However, reformat into eCTD is strongly recommended. Use of eCTD formats will become mandatory in these cases at a later point in time.

 

If the conversion to these formats represents undue hardship for applicants, there will be the possibility to request an exception to the obligation to submit the eCTD or VNeeS, which needs to be duly justified to BASG by presenting appropriate documents (compare §5 elektronische Einreichverordnung).

 

Please note:

Mandatory submission in eCTD from
01.01.2018for all variations and renewals in EU procedures
01.07.2018
for all new applications in purely national procedures
01.01.2019for all variation and renewal applications in purely national procedures
Mandatory submission in vNeeS from
01.07.2018
for all new applications in purely national procedures
01.01.2019for all variation and renewal applications in purely national procedures

Contact

In case of questions/comments please contact lcmbasg.gvat.

Created: 13.10.2016 | Page last modified: 30.04.2019

© Austrian Federal Office for Safety in Health Care
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