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    Application of cells, tissues and organs licence

    06.11.2017
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    Activity licence is required for procurement and handling of cells, tissues and organs of human origin.

    Although procurement and handling are considered as separate activities, it is possible to apply for the combined activity licence for both procurement and handling of cells, tissues and organs.

    The issue of an activity licence or variation of data contained in the activity licence is decided by the State Agency of Medicines. The activity licence is issued, if the applicant and premises comply with the requirements provided in Procurement, Handling and Transplantation of Cells, Tissues and Organs Act and in Rules for Procurement and Handling of Cells, Tissues and Organs (currently only Estonian version is available: Rakkude, kudede ja elundite hankimise ja käitlemise eeskiri). To ensure that compliance with these requirements is met, the State Agency of Medicines inspects conformity of the premises and practices before issuing or altering the activity licence. Compliance is also monitored after the activity licence is granted. Regular on-site inspections or other means of supervision will be carried out in the course of validity of an activity licence. Information of the activity licence will be included in the registry of the activity licences.

    The general process of application for an activity licence for the procurement and handling of cells, tissues and organs, is regulated by Chapter 4 of General Part of the Economic Activities Code Act.

    The application for the activity licence should be submitted to State Agency of Medicines using the following form:

    Application form

    Besides the application for procurement the additional documents have to be submitted to State Agency of Medicines. These documents are listed in the §19 subsection 2 of General Part of the Economic Activities Code Act and § 27 subsections 2 and 4 of Procurement, Handling and Transplantation of Cells, Tissues and Organs Act.

    Besides the application for handling the additional documents have to be submitted to State Agency of Medicines. These documents are listed in the § 19 subsection 2 of General Part of the Economic Activities Code Act and § 27 subsections 2 and 3 of Procurement, Handling and Transplantation of Cells, Tissues and Organs Act.

    Applicant has to pay the state fee.

    Please submit the applications by e-mail to info@ravimiamet.ee and add biol.info@ravimiamet.ee to the CC field.

    During the assessment of the application an on-site inspection or other means of supervision could be needed to make the decision.

    With its decision the State Agency of Medicines could approve or refuse to issue the activity licence.

    State Agency of Medicines will inform the applicant about the decision.