The Royal Decree of 9 January 2018 on biobanks, published in the Belgian Official Gazette on 05.02.2018 in implementation of Article 22 of the Law of 19 December 2008 regarding the procurement and use of human substances destined for human medical applications or for scientific research purposes, entered into force on 01.11.2018.

The Royal Decree on biobanks provides for:

  • the procedure whereby the biobank should declare itself to the Federal Agency for Medicines and Health Products, as well as the content of the declaration file;
  • rules relating to the harvesting of human substances intended for a biobank;
  • the provisions relating to changes to and cessation of the biobank’s activities;
  • the manner and frequency with which the biobank reports to the ethics committee and under what conditions the ethics committee can amend or withdraw its opinion;
  • the data that the register held by the biobank should contain;
  • the content of the agreement between the biobank and the recipient of the human substances;
  • the procedures relating to donor encoding, traceability and identification.

From now onwards, all biobank collections should be stored in a biobank recognized by the Federal Agency for Medicines and Health Products.  Several biobanks have already completed the notification procedure for biobanks and are willing to assist other biobanks /collections with this procedure or practical questions.

Do you have questions or issues with the notification of your biobank?
Are you looking for a biobank in which your sample collections can be included?
Take  a look at the list below and contact one of our biobanks to help you out!

If you have other questions, please contact us at