eCTD format required for all procedures

Report to all licensees or potential future licensees for drugs for human use: as of January 1, 2019, every file for acquisition of a license to market a drug for human use must be submitted in eCTD format.

Following the revision of the European eSubmission roadmap, as of January 1, 2019, every file for the acquisition of a license to market a drug for human use must be submitted in eCTD format. This obligation applies both to the national procedure, the mutual recognition procedure (MRP) and the central procedure (CP).

More information on eSubmission:

More information on the practical modalities:

New files

  • As of January 1, 2019, all newly submitted files, including those via national procedure, must respect the eCTD format. New files that are submitted after January 1, 2019 in the NeeS format will be rejected when uploaded (technical invalidation). The administrative fees will be retained.
  • For purely administrative variations in national procedures (e.g. the transfer of the licensee or change of distributor) and notifications under article 34 (4) for products certified via MRP/DCP, it is advised to submit via a country-specific eCTD sequence. More information on this is available in the CMDh Best Practice Guide on the use of eCTD in the MRP/DCP. In exceptional situations where a country-specific eCTD sequence is not possible, these types of submissions may still be made in the NeeS format. This exception does not apply to products licensed via the national procedure.
  • When switching to the eCTD format, it is advised to submit a 0000 sequence as a baseline and to also send it in the same CESP submission as the first file in eCTD format (sequence 0001) that you wish to submit. In this, the regulatory activity consistent with sequence 0001 must be selected in the CESP, in combination with the sub activity “initial”.
  • In the eCTD envelope for national submissions, it is preferred that the affected national procedure number is listed.

 

Current procedures

  • Answers to questions on a national procedure submitted in NeeS may also occur in NeeS format after January 1, 2019, unless in the interim (after January 1, 2019), a file (variation, renewal, notification ...) has already been submitted in eCTD format for the relevant pharmaceutical.
  • If you submit answers to questions for an MRP/DCP that was previously submitted as NeeS, the answers must be submitted in eCTD format from January 1, 2019. To be able to do this, you must resubmit the NeeS file in the eCTD format. The FAMHP hereby requests that you send the resubmission in eCTD format (sequence 0000) together with the responses in the eCTD format (sequence 0001) in one single CESP submission with the indication of the correct “regulatory activity” in combination with the sub activity “ATQ Procedure”.

The FAMHP would also like to remind you that the completely or partially rejected and withdrawn changes must be removed from the “current view” of the relevant eCTD(s) by submission of a consolidated eCTD sequence. These types of sequences can be submitted via CESP with the indication of the correct “regulatory activity” in combination with the sub activity “Closing Documents”. You will find more information via this link.

Last updated on
17/01/2019