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    Special authorisation for import and export and notification of conveyance of cells, tissues and organs

    25.04.2017
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    According to the Procurement, Handling and Transplantation of Cells, Tissues and Organs Act § 38 section 1 requirements for the import and export of cells, tissues and organs are established by the Medicinal Products Act.

    On the basis of the Medicinal Products Act §18 p 41 the import and export of cells, tissues and organs of human or animal origin that are intended for human application can be carried out by the holder of a cells, tissues and organs activity licence.

    According to the regulation of the Ministry of Social Affairs number 31 (entered into force 21 October 2005, last amendment on 10 March 2017) “The Conditions and Procedure for the Import and Export, Carrying for Personal Use and Sending by Post of Goods Requiring Special Authorisation of the State Agency of Medicines, the Forms of Special Authorisations and the List of Goods Requiring Special Authorisation of the State Agency of Medicines” conveyance of cells, tissues and organs of human or animal origin that are intended for human application within the European Economic Area must be reported to the State Agency of Medicines.

    In the case of cells, tissues and organs intended for human use, transportation outside the European Economic Area, meaning import and export, a special authorisation from the State Agency of Medicines is warranted prior to the import or export of goods.

    According to the Ministry of Social Affairs regulation number 31 §5 p 11 the following data is required by the State Agency of Medicines in the case of transportation, within the European Union, of cells, tissues and organs of human or animal origin:

    1. Name, address and e-mail of the notifier, name of the sender in case of  conveyance to Estonia and name of receiver in case of conveyance from Estonia, date of notification.
    2. Name of goods requiring special authorisation.
    3. Quantity in a package.
    4. Number of packages.
    5. Explanation about the use of goods requiring special authorisation.
    6. Certificate of cells, tissues and organs signed by the competent person of the cells, tissues and organs handler or responsible person or procurer of the cells, tissues and organs.

     

    The State Agency of Medicines must be informed of the distribution of goods requiring notification as soon as possible, but not later than five working days from the date of transportation. The State Agency of Medicines will confirm receipt of the notification.

    According to the Ministry of Social Affairs regulation number 31 §4 p 1 and 6, the following data is required by the State Agency of Medicines to apply for special authorization for importation or exportation outside the European Union:

    1. Name, address and e-mail of the notifier, name of the sender in case of  import to European Union and name of receiver in case of export from European Union, date of notification.
    2. Name of goods requiring special authorisation.
    3. Quantity in a package.
    4. Number of packages.
    5. Explanation about the use of goods requiring special authorisation.
    6. Certificate of cells, tissues and organs signed by the competent person of the cells, tissues and organs handler or responsible person or procurer of the cells, tissues and organs (please see the details for the certificate below1).

    The application must be submitted to the State Agency of Medicines at least five working days prior to the arrival of goods requiring special authorisation to the customs frontier or border between Estonia and another country in the European Economic Area. The State Agency of Medicines will reach a decision about issuing the import and export permit within five working days after receiving the application and other information and documents required. Special authorisation applies only for a single export or import event.

    According to “Rules for the procurement and handling cells, tissues and organs” the following minimum information must be indicated on the certificate of cells, tissues and organs:

    1. Name and code of the finished product;
    2. Date and time of procurement of the cells, tissues or organs;
    3. Expiry date for the cells and tissues;
    4. Results of the tests performed together with the acceptable range of variation;
    5. Confirmation concerning the compliance of the handling procedures with the approved work instructions;
    6. Decision concerning the release of cells, tissues or organs;
    7. Date of release of cells, tissues or organs;
    8. Name and signature of the person who made the decision on the release of the cells, tissues or organs.

    Notifications notices about conveyance of cells, tissues and organs within EU and applications for special authorisation for the import and export of cells, tissues and organs of human or animal use outside EU should be submitted through Client Portal, except in cases where the applicant does not have any means of electronic submission.

    If the special authorization for importation or exportation has been granted electronically, but no actual import or export has been taken place, State Agency of Medicines should be informed by e-mail (eriluba@ravimiamet.ee). 

     

    Import certificate for importing cells and tissues from a third country outside the European Union or the European Economic Area

    According to the changes in Procurement, Handling and Transplantation of Cells, Tissues and Organs Act from 19.03.2017 (implemented since 29 April 2017), The import of cells and tissues from third countries outside the European Union and the European Economic Area is only allowed based on the import certificate issued by the State Agency of Medicines.

    The requirements of the import certificate may be deviated from if:

     1) there is no other possibility to quickly import cells and tissues which are used immediately for a known recipient whose health would be in threat without such import;

     2) specific type of cells or tissues are imported which are intended for the individual use of the handler or procurer and for a third country supplier outside the European Union and the European Economic Area for a recipient which was known before the import.

    Application for an import certificate shall be submitted to info@ravimiamet.ee according to the § 252 of „Rules for procurement and handling of cells, tissues and organs“ (based on the directive (EU) 2015/566).

    Additional questions about special authorisation for import and export and notification of conveyance should be addressed to eriluba@ravimiamet.ee or tel +372 737 4140.

    Additional questions about application for an import certificate should be addressed to info@ravimiamet.ee or tel +372 737 4140.

     

    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.