Electronic application

The actual legal basis, valid since 01.01.2016 is available at: Elektronische Einreichverordnung.

From 1 January 2016 the use of electronic application forms (eAF) for MRP/DCP and national procedures (human and veterinary) will be mandatory within electronic submissions. Electronic Application Forms together with Guidance Documents and Questions and Answers can be found at eaf-eSubmission website.

The currently used application forms in Word format published by the European Commission will no longer be available and only the latest version of the electronic application form will be used for all EU procedures, including CP, MRP/DCP and national procedures.

Electronic Application Forms have to be used for:

  • New Applications according to §§ 7a, 9a, 9b, 9c, 9d, 10 Abs. 1(1), 10 Abs. 1 (2), 10 Abs. 9, 10a, 10b, 11, 11a and 12 AMG
  • Renewal Applications according to § 20 AMG
  • Variations according to Variation Regulation (EC) Nr. 1234/2008


For all other applications respective Application Forms  will still be available.


Guidance Documents for completing eAFs in national procedures is available in German.

 
In case of technical questions please contact eafema.europaeu or georg.neuwirtheragesat respectively nat@basg.gv.at for national applications, rms@basg.gv.at for applications where AT acts as RMS and basg-cms@basg.gv.at for applications where AT acts as CMS.

eCTD/VNees

When switching to the eCTD format, the BASG recommends that at least Module 3 be submitted as a baseline submission separately before any necessary amendment and renewal applications (in accordance with the Harmonised Technical Guidance for eCTD Submissions in the EU).

For further information regardiing the eCTD standard please consult the EMA website

National applications for registration of homeopathic and pharmacy proprietary medicinal products and their modifications and renewals are currently exempt from this obligation, although the switch to the eCTD format is also expressly recommended in these cases. The mandatory use of the eCTD format will be necessary at a later stage.

To the extent that the conversion to these formats represents an undue hardship for the party obliged to submit, it should be possible to apply to the BASG for an exemption from the obligation to submit eCTDs or VNeeS. The requirement of undue hardship must be substantiated to the BASG by submitting suitable documents (cf. §5 of the electronic submission ordinance).

Please note:

Mandatory submission in eCTD from 
01.01.2018for all variation and renewal applications in EU procedures
01.07.2018for all new applications in national procedures
01.01.2019for all requests for amendments and extensions in national procedures
Mandatory submission in vNeeS from 
01.07.2018for all new applications in national procedures
01.01.2019for all requests for amendments and extensions in national procedures

guides

For technical questions, please contact eafema.europaeu or georg.neuwirtheragesat or our functional e-mail addresses (natbasg.gvat for national applications, rms@basg.gv.at for applications with AT=RMS and basg-cms@basg.gv.at for applications with AT=CMS).

keyboard_arrow_up to top