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    Procedural guidance during COVID-19 pandemic

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    The European Commission, in collaboration with the network of Agencies, published questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic.


    The document is available here.


    The CMDh has agreed additional questions and answers that provide practical information on how to specifically address and apply the provisions determined by the European Commission for MR/DC procedures.


    Requests related to the  MA procedures should be sent to  mrp@ravimiamet.ee, please add subject title “COVID-19”.


    The requests for the exemption in the national language requirements of labelling/PIL   should be sent to documentation@ravimiamet.ee