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    Marketing authorisation of medicinal products

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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

    The use of the eAF (electronic application form) is mandatory for all applications. The electronic forms and supporting technical documentation have been published: http://esubmission.ema.europa.eu/eaf/index.html.

    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 2017