Can I import human body parts into Belgium for human use (i.e. from a country outside the European Economic Area)?
For human body material intended for human application, human tissues and cells intended for human application may only be imported into Belgium by an approved establishment for human body material (HBM). This HBM establishment must have a specific, additional import approval (approved importing institution). The body material must comply with Belgian legislation, in particular quality and safety standards. You can find this legislation through the following links: HBM law, Royal Decree on quality. The approved establishments can be found in the EU Tissue Establishment Compendium.
Regarding blood and blood products for transfusion, or even for the preparation of blood derivatives: in principle, these can only be imported by a blood establishment approved by the FAMHP. In Belgium, there are four approved blood establishments (Rode Kruis Vlaanderen, Croix Rouge de Belgique Suarlée, ETS de Mont-Godinne and La Transfusion Du Sang ASBL Charleroi). In the event that blood and blood components are imported from third countries, the Belgian blood establishments should ensure that the foreign supplying establishment has a quality care system, a traceability system and a reporting system for serious adverse reactions and events equivalent to the Belgian ones.
For all your questions regarding approvals of establishments for human body material and blood establishments, please contact the Recognition Human Body Material Entity (mch-mlm@fagg-afmps.be).
Can I import human body parts into Belgium for scientific research without human application (i.e. from a country outside the European Economic Area)?
Human tissues and cells intended for scientific research without application to humans may only be imported by an approved Belgian biobank. This obligation is independent of the fact whether the samples come from another biobank, a commercial organisation or a hospital. In this regard, however, please refer to the exception regime for extracted and artificialised material, as defined in the cited texts.
For all your questions regarding human body material for the purpose of scientific research, please contact biobanks@fagg-afmps.be.
Can I import human body parts into Belgium for diagnostic purposes without application to humans (i.e. from a country outside the European Economic Area)?
Article 3, § 3, d) of the HBM law states that the law does not apply to:
(translation) "the removal and operations performed with a purely diagnostic purpose for the benefit of the person from whom the body material is removed, and to the extent that such body material is not intended for another use."
As a result, diagnostic samples (including blood samples) as part of a patient's treatment are not within the FAMHP's competence. Depending on the specific demand (read: approval of healthcare professionals or hospitals, or exercise of healthcare professions), we refer you to the FPS Health, or the competent authorities at the Communities level.
Please note that this must be in the context of a patient's diagnosis and treatment - analysis of samples as part of a clinical trial is regulated separately - if you have specific questions about this matter, please do not hesitate to contact us.
Do I need authorisation to transport human body parts and blood products?
No specific separate authorisation is required for the transport of human body material and blood products. An agreement between the transporter and the manager of the establishment for human body material or the person in charge of the blood establishment is always required. The modalities for transport such as transport conditions, necessary documentation, etc. should be included in this agreement. It is the sponsor, the manager of the establishment for human body material or the person in charge of the blood establishment, who is responsible for the transport of the human body material or transfer within the EEA. The FAMHP verifies the compliance of the approved establishments for human body material (bank, intermediate structure or production establishment) and the approved blood establishments, and verifies whether the sponsor complies with the criteria provided by law.
Disclaimer
As your questions are related to different types of human body material, and various types of it, it is impossible to cover all of them in detail. Therefore, the following answer is quite general. For more details, please refer to the applicable legislation on the subject:
- human body material for application to humans: human body material (HBM) law (definition of human body material: article 2, 1° - scope: article 3) + implementing decrees;
- human body material for scientific research without application to humans: HBM law (including definition of human body material: article 2, 1° - scope: article 3; basic provisions biobank - article 22) + implementing decrees;
- collection and testing of blood and blood components regardless of the intended use, and processing, storage and distribution of blood intended for transfusion: blood law + implementing decrees.
Given the very general nature of the questions, we also reserve the right to have a closer look at the final document and give a different answer, as a result of any specific situation (which could possibly fall under an exception).
Regarding the import process (i.e. coming from outside the European Economic Area) of human body material and blood products, there are different requirements depending on the intended purpose.