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    Tartu Administrative Court refused to grant Vitabalans OY’s action on the annulment of negative decision on marketing authorisation application

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    Vitabalans OY submitted an application for a marketing authorisation of medicinal product IBUZAP 400 mg film-coated tablets. The Republic of Estonia was acting as the Reference Member State in the decentralised procedure and Czech Republic, Denmark, Finland, Hungary, Latvia, Lithuania, Poland, Sweden, Slovakia, Germany and Slovenia were the Concerned Member States.

    Based on the final positions of the RMS and CMSs in the marketing authorisation procedure the applicant was not able to prove the quality of the active substance of the medicinal product. There was insufficient information available on impurities that may occur during the manufacture of the active substance and on their possible effects on humans during the usual use of the medicinal product.

    05.06.2019 State Agency of Medicines refused to grant the marketing authorisation for medicinal product IBUZAP 400 mg film-coated tablets.

    Vitabalans OY brought an action in Tartu Administrative Court on 19.06.2019, requesting the annulment of the Assessment report and the negative decision for the marketing authorisation made by the State Agency of Medicines.

    25.02.2020 Tartu Administrative Court found in its judgement that State Agency of Medicines could not have decided differently than its decision not to grant the marketing authorisation (no RR-4/409). Tartu Administrative Court concluded that the decision is without errors in assessment and is sufficiently motivated.

    An appeal against the judgement can be lodged to the Tartu Circuit Court within 30 days from the judgement date.