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    DCP with Estonia as RMS

    25.04.2017
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    The companies wishing to use Estonia as the Reference Member State in DCP are advised to contact the State Agency of Medicines well in advance.

    The requests for DCP with Estonia as a RMS should be sent to mrp@ravimiamet.ee.

    For request for human medicinal products, please fill in the request form published on the CMDh web-page. For veterinary medicinal products the same data (active ingredient, strength(s), pharmaceutical from, active ingredient manufacturer, legal basis of the application and preferred submission date) should be presented.

    The applicants will be informed whether a time slot has been booked for their submission or not.

    SAM should be notified of any changes in agreed submission dates. The changes in active ingredients are decided on a case-by-case basis.

    The next slots for decentralised procedures are available for 2017 Q3-Q4 and 2018 Q1-Q4.