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

Union Product Database (UPD)
Since the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) enterd into force, the active use of the UPD for variations not requiring assessment (VNRA) is obligatory for the applicant / marketing authorisation holder.

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 eaf@ema.europa.eu or georg.neuwirther@ages.at 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.

CESP eliminates the need to submit paper applications, DVDs and CDs for medicines approvals, variations and renewals.

CESP simplifies the submission of documents by eliminating the need to physically submit paper applications, CDs or DVDs to the Authority.

CESP can be accessed through the HMA's website. Users can register via this website. To do this, each company must define an administrator. This administrator can create and manage additional users. The website also contains FAQs, training videos and all other information about CESP. accepted dossiers via CESP

•     Dossiers for new applications, amendments and renewals for NAT and MRP/DCP procedures
•     Submission of clinical studies veterninary

Enquiries If you have any questions about specific CESP submissions, please contact cesp@basg.gv.at. Further information on CESP can be found at the HMA.

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:

For technical questions, please contact eaf@ema.europa.eu or georg.neuwirther@ages.at or our functional e-mail addresses (nat@basg.gv.at for national applications, rms@basg.gv.at for applications with AT=RMS and basg-cms@basg.gv.at for applications with AT=CMS).