• English
  • Eesti

    Guidance to facilitate the submission of documents concerning applications for marketing authorisations to the State Agency of Medicines

    26.04.2017
    Printer-friendly version

    The documentation concerning the marketing authorisations for human and veterinary medicinal products should be submitted electronically only.

    State Agency of Medicines encourages the applicants to use CESP (Common European Submission Portal) for submission of marketing authorisation documentation.

    We accept all types of submissions for marketing authorisations for human and veterinary medicinal products via CESP: national and MRP/DCP new applications, renewals, variations, response documents, PSURs for veterinary medicinal products, ASMFs etc.

    There is no size limit for CESP submissions.

    If the applicant cannot use CESP the following ways of submissions are accepted:

    • Via email (if < 10 MB) or Eudralink (if < 200 MB per one file) to the e-mail address

    documentation@ravimiamet.ee: applications, responses and additional documentation for marketing authorisation, renewal and variations via national and MRP/DC procedure.

    mrp@ravimiamet.ee: translations of final product information for MRP/DC procedures (initial, renewal, variations)

    • On CD/DVD to postal address: 1 Nooruse Str, 50411 Tartu, Estonia

    Only one way of submission must be used. Sending double submissions leads to confusion and will delay processing of the application.

    Centralised Procedure applications for human medicinal products must not be submitted to the State Agency of Medicines. Further guidance can be found here.

    PSUR submission

    Submitting PSURs for veterinary medicinal products

    PSURs for veterinary medicinal products should be submitted via CESP or to the e-mail address documentation@ravimiamet.ee. For submissions larger than 10MB please use CESP (preferred) or send 1 CD/DVD to postal address: 1 Nooruse Str, 50411 Tartu, Estonia.

    Submitting PSURs for human medicinal products

    From 13 June 2016 all PSURs for human medicinal products must be submitted electronically via eSubmission Gateway / Web Client to the PSUR Repository.  Information regarding PSUR Repository is available on the EMA eSubmission website.


    Requirements for eSubmission

    State fees: The state fee has to be paid prior to the submission of the application and the proof of payment should be enclosed (State fee).

    Samples: The applicant is not required to submit the sample of the medicinal product with the MA application. One sample has to be presented when the medicinal product is actually launched.

    Assessment fees: An invoice on the assessment fee will be sent within 10 days after acceptance of the application for processing. The applicant shall pay the fee within 40 days after presentation of the invoice. (Assessment fee)