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    eSubmissions

    20.12.2018
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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.