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    Marketing authorisation of medicinal products

    06.06.2016
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    An application for a marketing authorisation for a human or veterinary a medicinal product may be filed under the mutual recognition, decentralised, centralised or the national procedure.

    The requirements of quality, safety and efficacy are based upon the Medicinal Products Act of 2005 and respective regulations by the Minister of Social Affairs.

    The submission of the applications for a marketing authorisation but as well as variation and renewal applications is very easy in Estonia, there is no need for paper copies, all applications can be submitted electronically and there are no country-specific requirements for supplementary documentation.


    Application forms and information on fees

    • The use of the eAF (electronic application form) is mandatory from 1st January 2016 for all applications (human and veterinary MRP, DCP and national procedure applications for marketing authorisation, renewal and variations). Further details can be found on: http://esubmission.ema.europa.eu/eaf/index.html” and CMDh website.
       
    • Mandatory submission of new applications for DCPs (veterinary) in VNeeS
      As of 1st January 2016, State Agency of Medicines no longer accepts new DCP applications for veterinary medicinal products that are not submitted in valid VNeeS format http://esubmission.ema.europa.eu/tiges/vetesub.htm.


    Fees

    There are two types of fees for the marketing authorisation applications in Estonia.

    The state fee has to be paid prior the submission of the application. For the assessment fees, the invoice will be issued upon receipt of the valid application. No payment of assessment fee should be made in advance.

    State fees
    Refund of the state fee
    Assessment fees


    Templates for product information

    Templates for MRP/DCP and national procedures (Estonian)

    Human medicines - The template indicates updates (tracked) of last two versions.
    Veterinary medicines

    QRD templates for centrally authorised products

    Human medicines
    Veterinary medicines

     

    Related links

    Authorised products
    Authorised veterinary products
    The meetings of the marketing authorisation committees in 2016