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    Biovigilance

    07.04.2017
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    According to the Procurement, Handling and Transplantation of Cells, Tissues and Organs Act biovigilance means the provision of information concerning any serious adverse event associated with the handling of cells, tissues and organs and any serious adverse reaction occurring at the time or after transplantation of cells, tissues or organs into a recipient, and the procedure for establishing the reasons thereof.
    A serious adverse event (SAE) means an unwanted and unexpected event associated with any step of the process from the removal of cells, tissues or organs to the transplantation and which may lead to the transmission of infectious agents of communicable diseases, to death, be life-threatening for living donors or recipients, cause disability or incapacity or which may result in, or prolong, hospitalisation or morbidity.

    In the case of procurement and handling of gametes and embryos, a serious adverse event (SAE) shall be deemed to be, in addition to the previous, an unwanted and unexpected event associated with any step of the process from the removal of gametes to the transplantation, the consequence of which is the formation of an unsuitable embryo, loss of biological material or transplantation thereof into a person not intended therefor and if the child born as a result of application of the gametes or embryo of a donor suffers from a serious or life-threatening genetic disease.


    A serious adverse reaction (SAR) means an unintended response in the living donor or in the recipient which may be associated with any step of the process from the removal of cells, tissues or organs to the transplantation and which is fatal, life-threatening, disabling or incapacitating or which results in, or prolongs, hospitalisation or morbidity.

    It is important to ensure the traceability of human cells, tissues and organs through the procedure, from donor to recipient and vice versa, in order to discover and investigate serious adverse reactions and serious adverse events and recall the cells, tissues and organs which do not meet the criteria of quality by effective means and without delay.

    Notification of serious adverse events and serious adverse reactions

    Under the legislation the Procurer or Handler shall without undue delay notify the State Agency of Medicines and the national transplantation agency of serious adverse events and serious adverse reactions which have become evident upon the handling of cells, tissues and organs or after the handling.


    The final report about the causes, procedures and results has to be submitted to the State Agency of Medicines and the national transplantation agency in reasonable time after the notification.

    Formats are presented in Annexes 4, 5, 7 and 8 of Regulation No. 10.

    Annual reports
    Procurers and Handlers have to submit annual reports concerning serious adverse events and serious adverse reactions which occur during a calendar year to the State Agency of Medicines not later than by 1 April of the following year.
    Formats are presented in Annexes 6 and 9 of Regulation No. 10.

    Based on the information forwarded to the State Agency of Medicines, an annual consolidated report concerning the serious adverse effects and the serious adverse reactions is prepared by the State Agency of Medicines.

    Procurement, Handling and Transplantation of Cells, Tissues and Organs Act

     

    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 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 biovigilance of cells, tissues and organs to biol.info@ravimiamet.ee