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    Regulatory Guidance

    24.04.2017
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    The Notice to Applicants is prepared by the European Commission to give the harmonised views how the legal requirements of the Directives and Regulations may be met.

    Human medicines

    Veterinary medicines

    The State Agency of Medicines has prepared guidance papers to facilitate the authorisation process and to give the necessary contact points for different questions.


    Guidance for submission of documents

    eSubmissions

    Requirements for signatures

    Guidance for submission of product information

    Pharmaceutical terminology

    Additional risk minimisation measures (aRMM) - Submission of educational materials

    CMDh position paper on the use of the QR codes and Annex 2: Applicant’s declaration