Source: https://www.basg.gv.at/en/healthcare-professionals/blood-safety/authorisation-and-inspection-of-blood-establishments
Timestamp: 2020-04-06 05:24:55
Document Index: 791098788

Matched Legal Cases: ['§ 14', '§ 63', '§ 65', '§ 14', '§ 63', '§ 63', '§ 65']

Authorisation and inspection of blood establishments - BASG
Definition and benefits Inspection procedure Forms FAQ Blood Inspection
FAQ Blood Inspection
Authorisation and inspection of blood establishments New
During the inspection/approval procedure, the blood establishments are assessed whether they comply with the Austrian Medicines Act (AMG) and/or the Blood Safety Act (BSG) and its ordinances as well as if the facility/premises with all implemented safety measures ensure the best possible protection of donors and patients.
The procedure has now been completed (AVG).
Guideline: Description of the authorisation procedure (L_I06)| 37 KB
Form: Application for authorisation or amendment of authorisation (F_I01)| 109 KB
§ 14 (1) and (3) BSG refer to operation or amendments concerning the donation and testing, § 63 and § 65 AMG to operation or amendments concerning the processing, storage or distribution.
Form: Registration of a responsible person subject to registration (F_I162)| 95 KB
Form: Deregistration of a responsible person subject to registration (F_I131)| 93 KB
What is subject to authorisation?
Is the radioactive irradiation of blood or blood components a manufacturing process subject to authorisation?
In the field of blood safety, a basic distinction is made between the authorisation/amendment laid down in the Blood Safety Act (BSG) (§ 14 (1) and (3)) and pursuant to the Austrian Medicines Act (AMG) (§ 63 and 65). The authorisation/amendment according to the BSG concerns the donation and testing of blood and blood components. The authorisation/amendment according to the AMG covers the processing, the storage and the distribution of blood and blood components.
Typical examples of amendments according to BSG: new procedure in donor testing (e.g. change of method for haemoglobin determination), relocation of donor premises.
Typical examples of amendments according to AMG: new processes in processing (e.g. introduction of pathogen inactivation), relocation of processing, laboratory and storage facilities
In Article 5(1) of Directive 2002/98/EC it is laid down that activities relating to the collection and testing of human blood and blood components, whatever their intended purpose, and to their preparation, storage, and distribution when intended for transfusion, are undertaken only by the blood establishments which have been designated, authorised, accredited or licensed by the competent authority for that purpose.
In the implementing Directive 2005/62/EC 'processing' is defined as any step in the preparation of a blood component that is carried out between the collection of blood and the issuing of a blood component.
According to the Austrian Medicines Act (AMG), human blood or blood components, which are intended to be used for transfusion, are not considered medicinal specialities, but meet the definition of medicinal product. Consequently, § 63 AMG and § 65 AMG are to be applied, also because the irradiation process has an effect on the quality of the medicinal product.
Irradiation (e.g. 3 min. / 25 Gray) prevents the growth of transfused lymphocytes in the recipient and thus the development of GvHD (Graft-versus-Host-Disease). Already 10^4 transfused cells / kg body weight of a patient can trigger GvHD (in immunosuppressed patients 10^4 and in patients without immunosuppression 10^7).
Irradiation irreversibly damages the DNA of the lymphocytes. Irradiation prevents the proliferation of lymphocytes and the colonisation of foreign clones. These foreign clones ultimately triggers the rejection reaction against the host.
Other diseases are not prevented by the irradiation, e.g. transmission of viruses or bacteria. For the purpose of pathogen inactivation, mostly additional chemical substances in combination with other types of radiation (e.g. UV) are necessary.
Most recipients are immunocompromised patients (bone marrow / blood stem cell transplant patients, patients before autologous blood stem cell collection, and patients with congenital immunodeficiency). In addition, similar to patients with leukaemia, malignant lymphomas and tumours, the blood components from first-degree relatives have to be irradiated. Furthermore, granulocyte preparations have a high content of lymphocytes and therefore are always irradiated.
Irradiation can prevent transfusion associated - GvDH by inhibiting the replication of immunocompetent cells. The functionality of thrombocytes and granulocytes is not affected by the procedure.
Page last modified: 31. March 2020