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

According to the “Handling and Transplantation of Cells, Tissues and Organs Act” §13³   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 8 March 2010) “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” import and export 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 contact information of sender and receiver of the goods requiring special authorisation.
2. Border crossing point of goods and means of transport.
3. Name of goods requiring special authorisation.
4. Quantity in a package.
5. Number of packages.
6. Explanation about the use of goods requiring special authorisation.
7. Certificate of cells, tissues and organs signed by the competent person of the cells, tissues and organs handler.
8. Notification must include the number of the notification, the name of the notifier, contact information and the date of the notification.

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 contact information of sender and receiver of the goods requiring special authorisation.
2. Border crossing point of goods and means of transport.
3. Name of goods requiring special authorisation.
4. Quantity in a package.
5. Number of packages.
6. Explanation about the use of goods requiring special authorisation.
7. Certificate of cells, tissues and organs signed by the competent person of the cells, tissues and organs handler (please see the details for the certificate below¹).
8. Date, name of the applicant and contact information.

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.

¹According to the Ministry of Social Affairs regulation number 83 of 19 December 2008 “Rules for 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 and expiry date of the cells, tissues or organs;
3. Results of the tests performed together with the acceptable range of variation;
4. Confirmation concerning the compliance of the handling procedures with the approved work instructions;
5. Decision concerning the release of cells, tissues or organs;
6. Name and signature of the person who made the decision on the release of the cells, tissues or organs.

Notification notice of the transportation of cells, tissues and organs of human or animal origin in or out of Estonia, but within EU can be sent to teavitus@ravimiamet.ee or fax + 372 737 4152

Application for special authorisation for the import and export of cells, tissues and organs of human or animal use in and out of Estonia from outside EU can be sent to: eriluba@ravimiamet.ee or fax  + 372 737 4152