FAQ electronic Submission

1. must applications be submitted in electronic form (eCTD, NeeS)?

Yes, because on 1 January 2016, the amended Ordinance of the Federal Office for Safety in Health Care on the electronic transmission of applications and notifications (Electronic Ordinance on the Submission of Medicinal Products 2011 -EEVO 2011) for the authorisation/registration and lifecycle management of medicinal products will come into force.

For further information on the submission of documents, please refer to Guideline: electronic Release Regulation EEVO (L_Z45).

2. how should the CD or DVD's be labelled?

For information on how to submit documents, see Guideline: electronic Release Regulation EEVO (L_Z45).

3. are NeeS submissions still accepted by the BASG?

Yes, national applications for registration of homeopathic and pharmacy proprietary medicinal products and their modifications and extensions are currently exempted from the eCTD obligation (see Mandatory use of eCTD and VNeeS also for purely national submissions ).

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.

Amendment and renewal applications must be submitted in eCTD format in the MR procedure since 1 January 2018 and in the national procedure since 1 January 2019.

4 Why is the eCTD format preferred by the BASG?

eCTD has the advantage of better traceability of document versions for authorities and applicants and is therefore preferred.

5. what security measures must be observed for electronic submissions?

Password protection: Security settings are not allowed at the submission level for whole or individual files. In the case of password protection, electronic submissions cannot be accepted.

Virus protection: The applicant is responsible for checking the submission for viruses. The scan should be carried out with a current virus scan program and confirmed in the accompanying letter.

Transport security: The physical security of the submission during transport is the responsibility of the applicant. Upon receipt by BASG the responsibility for the safety and integrity of the submission lies solely in the hands of BASG. Non-readable or defective data carriers are exclusively requested anew.

6. which data carriers should be used for electronic submission?

For information on how to submit documents, see Guideline: electronic Release Regulation EEVO (L_Z45) .

7. how to send additional documents?

For information on how to submit documents, see Guideline: electronic Release Regulation EEVO (L_Z45).

8. how to proceed with MRP/DCP?

The submission of eCTDs and NeeS is also possible in the MRP/DCP procedure. However, the instructions for MRP/DCP must be observed separately.

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

9. what should I bear in mind when switching from a paper dossier to an eCTD format? Is it possible to submit an amendment in eCTD format even though the existing dossier is in paper form?

A consolidated, current version of the dossier in Baseline eCTD format is highly recommended, otherwise the lifecycle cannot be established. The first sequence must be '0000'.

10. which validation criteria are used for the technical validation?

The BASG Authority uses the following published validation criteria: see above valid eCTD Validation Criteria.

11. can other electronic compilations than NeeS and eCTD be accepted for human medicinal specialities?

No.

12. where can I find information on electronic application forms?

Further information on electronic application forms (eAFs) and their application can be found here.

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

As a rule, the baseline submission must be managed as sequence 0000. This applies even if NeeS sequences already exist for the respective product. In order to ensure the correct merging and archiving of the dossier, a UUID is created that is identical in all sequences in the current eCTD lifecycle.

2nd baseline submission with sequence 0000

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

  • re-format from NeeS/Others to eCTD
  • Change from national to MR-/DC procedure
  • re-baselining of an interrupted eCTD lifecycle
  • Change from one eCTD lifecycle pro strength to one common eCTD lifecycle
  • for technical reasons, e.g. when a new eCTD tool is used
  • in the case of a transfer, if the new holder cannot take over the eCTD sequences for technical reasons

The first regulatory activity is then submitted with sequence 0001.

3. baseline submission at a later stage in the lifecycle

It is possible to submit a baseline submission with a higher sequence number for modules 3, 4 or 5 at a later time in the lifecycle. In this case the same UUID must be observed.

This allows documents to be submitted that have not yet been received in eCTD format.

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