Electronic submission

FAQ Electronic submission

Leitfaden (L_E67) eService Zulassung und Lifecycle von Arzneispezialitäten.

1. Does the Austrian Federal Office for Safety in Health Care (Bundesamt für Sicherheit im Gesundheitswesen, BASG)/AGES Austrian Medicines and Medical Devices Agency (AGES Medizinmarktaufsicht) accept submissions in electronic format (eCTD, NeeS)?

 

Yes, from January 1st 2016 the amanded order of BASG/AGES Austrian Medicines and Medical Devices Agency about the transmission of electronic submission order (Elektronische Einreichverordnung 2011 –EEVO 2011),
for all types of medicinal procedures (see Guidelines & Standards) is valid. 
Further information about the transmission of documents see guide L_Z45_Leitfaden_zur_Elektronischen_Einreichverordnung_EEVO.

2. How should the submitted CDs or DVDs be labelled?

Information about the transmission of documents see guide L_Z45_Leitfaden_zur_Elektronischen_Einreichverordnung_EEVO.

3. Will BASG/AGES Austrian Medicines and Medical Devices Agency continue to accept NeeS submissions?

National new applications for registration of homeopathic and pharmacy-owned medicinal products including their lifecycle are excluded from these provisions (see eCTD/VNeeS will also be mandatory for purely national applications).

 

The use of the eCTD format has been mandatory for new applications in the DC procedure since 1 July 2015 and for new national applications since 1 July 2018.

 

Applications for Variations and Renewals have to be submitted in eCTD format in MR-procedures since 1 January 2018 and in national procedures since 1 January 2019.

4. Why does BASG/AGES Austrian Medicines and Medical Devices Agency prefer the eCTD format?

The eCTD is preferred because it has the advantage of providing better version control of documents for both authorities and applicants.

5. Which security measures should be taken with electronic submissions?

Password protection:
Security settings at the level of the entire submission or at file level are not allowed. Electronic submissions that are password-protected will be rejected.


Anti-virus protection:
The applicant is responsible for scanning the submission for the presence of viruses. Scanning should be performed using up-to-date antivirus software and should be confirmed in the cover letter.


Transport security:
The physical safety of the submission during transport lies within the responsibility of the applicant. After receipt of the submission by BASG/AGES Austrian Medicines and Medical Devices Agency, the responsibility for its safety and integrity lies solely with BASG/AGES Austrian Medicines and Medical Devices Agency. Unreadable or defective storage media will invariably have to be replaced by the applicant.

6. What types of data storage media can be used for electronic submissions?

Information about the transmission of documents see guide L_Z45_Leitfaden_zur_Elektronischen_Einreichverordnung_EEVO.

7. How should additional documents be submitted?

Information about the transmission of documents see guide L_Z45_Leitfaden_zur_Elektronischen_Einreichverordnung_EEVO.

8. How should we proceed in MRPs and DCPs?

eCTDs and NeeS submissions are also possible in MRPs and DCPs. However, please refer to the CMDh Best Practice Guide on the use of the electronic Common Technical Document (eCTD) in the mutual recognition and decentralised procedures for more detailed information.

The use of the eCTD format is obliging for new applications in the DC procedure since the 1st of July, 2015.

9. What should be considered when changing a dossier from paper to eCTD format? Can variations be submitted in eCTD format when the original dossier is available in paper format only?

It is urgently recommended to prepare a consolidated up-to-date version of the dossier in eCTD format. Without a baseline eCTD, a sustainable life-cycle management process cannot be established. The first sequence must be ‘0000.’

10. Which criteria are used for technical validation?

BASG/AGES Austrian Medicines and Medical Devices Agency uses the following published validation criteria: eCTD Validation Criteria 5.0.

11. Can electronic compilations other than NeeS and eCTD be used for proprietary medicinal products for human use?

No.

12. Where can I find information regarding electronic application forms (eAFs)?

Further information regarding electronic application forms (eAFs) and can be found at:

http://www.basg.gv.at/en/medicines/electronic-application/elektronisches-antragsformblatt/

13. eCTD baseline submissions

according to Harmonised Technical Guidance for eCTD Submissions in the EU (Version 4.0, April 2016) and CMDh Best Practice Guide on the use of the Electronic Common Technical Document (eCTD) in the Mutual Recognition and Decentralised Procedures (July 2017)

1. General information

Normally, the baseline submission will be sequence 0000, even if NeeS sequences already exist for the respective product. To allow for correct merging and archiving of the dossier, a UUID is created, which will be identical in all sequences in the current eCTD lifecycle.

2. Baseline submission with sequence 0000

A baseline with sequence 0000 and a new UUID are required in the following cases:

  • re-formatting from NeeS/Others to eCTD
  • change from national to MR-/DC-procedure
  • re-baselining of an interrupted eCTD lifecycle
  • change from one eCTD lifecycle per strength to a joint eCTD lifecycle
  • for technical reasons, if, eg, a new eCTD tool is used
  • after a change of ownership, if the new MAH cannot resume the eCTD sequences for technical reasons

The first regulatory activity will be submitted with sequence 0001.

3. Baseline submission at a later stage in the lifecycle

It is possible to submit a baseline with a higher sequence number for modules 3, 4 or 5 at a later stage in the lifecycle. In this case, adhering to the identical UUID is imperative.

This allows for the re-submission of documents, which have not been supplied in eCTD format before.

Created: 06.05.2010 | Page last modified: 19.03.2018

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