Book I: Protection and promotion of maternal and child health

The authorisation to import or export gametes or germ tissue is issued in response to a request from a couple or an unmarried woman for the purposes of medically assisted procreation or at the request of a person whose gametes or germ tissue are stored for the purposes of medically assisted procreation, or the preservation and restoration of fertility or the restoration of hormonal function, pursuant to Articles L. 2141-1,…

Only establishments, organisations, health cooperation groups and laboratories authorised to carry out the biological activities of medically assisted procreation mentioned in 2° of article R. 2142-1 may obtain authorisation to import and export gametes or germ tissue. The authorisation referred to in article R. 2141-24 is issued for each planned import or export operation.

Any health establishment, organisation, health cooperation group or medical biology laboratory mentioned in article R. 2141-25 and which imports or exports gametes from donations for the purposes of medically assisted procreation shall ensure that they have been obtained in accordance with the principles mentioned in article L. 2141-11-1 and applicable to such donations. Health establishments, organisations, health cooperation groups or medical biology laboratories must not divulge any information that could…

The application for authorisation shall be sent to the Director General of the Agence de la biomédecine by any means capable of establishing a date of receipt. The applicant must enclose with the application a file containing all the information required to verify compliance with the provisions of Article L. 2141-11-1 and this Title, the model for which is laid down by decision of the Director General of the Agence…

The procedures for examining the application and the response from the Director General of the Agence de la biomédecine comply with Article R. 2141-16.

When gametes or germinal tissue are transported, they are accompanied by a document that cannot be separated from the primary packaging. It contains the following information 1° A copy of the import or export authorisation issued by the Agence de la biomédecine ; 2° The precise designation of the gametes or germinal tissues concerned; 3° Information enabling the gametes or germ tissue to be traced, including the date of collection…

Any import or export of gametes or germinal tissue is subject to the following information being affixed to the external packaging, in addition to the information mentioned in 4° to 7° of Article R. 2142-29: 1° “Gametes” or “germinal tissue”, “fragile” and “do not irradiate”; 2° The date and time of dispatch.

Any incident or adverse reaction occurring during the import or export operation and likely to affect the quality or safety of gametes or germ tissue must be reported to the person referred to in 6° and 7° of article R. 2141-29.

Where the Director General of the Agence de la biomédecine finds that the requirements laid down in the import or export authorisation have not been complied with, he may immediately suspend the authorisation. After a formal notice has been sent to the authorisation holder, giving him/her the opportunity to comment within a period of fifteen days, the Director may withdraw the authorisation.