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    Special authorisation for import and export and notification of import and export of blood components

    11.04.2017
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    According to the Ministry of Social Affairs Regulation No.31, 18 February 2005 (available in Estonian), blood and blood components are considered to be medicines, requiring special authorisation for transport and export/import to/from the European Economic Area (EEA) and third countries.


    Transport from/to EEA

    In the case of transportation of blood and blood components to a Member State of the European Economic Area, the State Agency of Medicines requires written notification. Data required for such a notification is listed in the Ministry of Social Affairs Regulation No.31, 18 February 2005, §5 (1):

    1. Date of the transportation
    2. Name, address and contact information of sender and receiver
    3. name of the product
    4. product quantity within packages (if applicable)
    5. number of  packages
    6. Identification numbers of blood components

    The notification should also include the notification number, the name and contact details of the notifying person and the date of the notification.

    The State Agency of Medicines should be notified about transportation as soon as possible, but in any event, no later than 5 working days after the transportation occurred.


    Export and import to/from third countries

    Export and Import of blood and blood components used for medical purposes outside the European Economic Area requires an application for import/export special authorisation. The Medical Product Act sets in §18 the list of importers and exporters, who have the right for import and export of medicinal product.

    Data required for such an application is listed in the Ministry of Social Affairs Regulation No.31, 18 February 2005, §4 (1) and (6). The application should therefore contain:
    • the names of importer and respective exporter
    • their addresses and contact details
    • transport means and border crossing point
    • name of the product
    • product quantity within packages (if applicable)
    • number of packages
    • written explanation of product purpose

    The application should also include the application number, the name and contact details of the applying person and the date of the application.

    An application should be submitted to the State Agency of Medicines at least five working days before medicines requiring special authorisation arrive at the customs frontier or the border between Estonia and an Member State of the European Economic Area.