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    Application of cells, tissues and organs licence

    07.04.2017
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    Cells, tissues and organs can only be procured and handled by holders of a respective activity licence for cells, tissues and organs.

    In order to obtain an activity licence the applicant and the site of activity have to comply with the requirements set out in the Procurement, Handling and Transplantation of Cells, Tissues and Organs Act and relevant Regulations of the Minister of Social Affairs.

    The issue of an activity licence or alteration of data contained in the activity licence is decided by the State Agency of Medicines.
    Before issuing or altering of an activity licence the State Agency of Medicines inspects the conformity of the premises and practices in relation to the licensed activity. To ensure that compliance with these requirements is maintained, compliance is monitored through regular on-site inspections in the course of validity of an activity licence.

    Upon application for an activity licence, an application and the documents and information related to procurement and handling operations regarding cells, tissues and organs according to Procurement, Handling and Transplantation of Cells, Tissues and Organs Act have to be submitted to the State Agency of Medicines.
    Payment of the applicable state fee is also required.

    NB! Since 01.03.2015 the new Procurement, Handling and Transplantation of Cells, Tissues and Organs Act has come to force. Due to lack of English translation of the related regulations, please contact State Agency of Medicines for further information about Estonian legislation of cells, tissues and organs for human application.

    Please address any questions related to the activity licenses for cells, tissues and organs to biol.info@ravimiamet.ee