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For submisson of electronic documentation CESP (Common European Submission Portal) is highly recommended.

The CESP delivery file/e-mail content/labelling of the CD/DVD should include the following information:

  • Name of the applicant/MAH
  • Name of the product
  • Marketing authorisation number
  • For MRP/DCP products the procedure number
  • Submission type (e.g. Marketing Authorisation Application, Variation Type II, Renewal, ASMF)
  • Submission description e.g initial submission, responses etc.
  • Format of the submission
  • eCTD/NeeS sequence number

According to the EU eSubmission Roadmap eCTD format is mandatory for all submissions for human medicinal products from 1 January 2019.

For veterinary medicinal products, the VNeeS format is mandatory for all submissions for veterinary medicinal products from 1 January 2019.

The State Agency performs technical validation of electronic submissions against the current EU technical validation criteria published on the EMA eSubmission website.
eCTD/NeeS: http://esubmission.ema.europa.eu/ectd/index.html
VNeeS: http://esubmission.ema.europa.eu/tiges/vetesub.htm

The guideline for e-submissions in decentralised and mutual recognition has been published on CMDh http://www.hma.eu/277.html and CMDv http://www.hma.eu/571.html websites.

Guidance for CESP submissions:

  • Separate CESP submission for each application is required to facilitate the processing of the applications.
  • The same CESP number must never be reused.
  • We advise the applicant to use the comments field of the delivery file to indicate specific information on the submission (e.g. in case of a replacement submission the reason for resubmission must be marked there in order to avoid confusion).
  • Requirements for users of the CESP system on the correct use of Zip files, folder and file names for submissions transferred using the CESP system: Guidance for Zip files, Folder and File Names.