Cap. 483 Art. 2Interpretation. Cap. 458. Cap. 464.

In this Act, unless the context otherwise requires -"allogenic use" means cells or tissues removed from one person and applied to another; "autologous transfusion" means transfusion in which the donor and the recipient are the same person and in which pre-deposited blood and blood components are used;

"autologous use" means cells or tissues removed from and applied in the same person;

"blood" means whole blood collected from a donor and processed either for transfusion or for further manufacturing;

"blood component" means a therapeutic constituent of blood (red cells, white cells, platelets, plasma) that can be prepared by various methods; "blood component release" means a process which enables a blood component to be released from a quarantine status by the use of systems and procedures to ensure that the finished product meets its release specification;

"blood establishment" means any structure or body that is responsible for any aspect of the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage and distribution when intended for transfusion, but does not include a hospital blood bank;

"blood product" means any therapeutic product derived from human blood or plasma;

"cells" means individual human cells or a collection of human cells when not bound by any form of connective tissue;

"the Commission" means the European Commission; "deferral" means suspension of the eligibility of an individual to donate blood or blood components, such suspension being either permanent or temporary;

"Directive 2004/23/EC" means the Commission Directive 2004/ 23/EC of the European Parliament and of the Council of 31 March, 33/EC of 22 March, 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components; "distribution" means in the case of blood and blood components, the act of delivery of blood and blood components to other blood establishments, hospital blood banks and manufacturers of blood and plasma derived products. It does not include the issuing of blood or blood components for transfusions. In the case of human tissues and cells "distribution" means transportation and delivery of tissues or cells intended for human application;

"donor" means every human source, whether living or deceased, of human cells or tissues;

"donation" means donating human tissues or cells intended for human applications;

"establishment" includes a blood establishment and a tissues and cells establishment;

"haemovigilance" means a set of organised surveillance procedures relating to serious adverse or unexpected events or reactions in donors or recipients, and the epidemiological follow-up of donors; "hospital blood bank" means a hospital unit which stores and distributes and may perform compatibility tests on blood and blood components exclusively for use within hospital facilities, including hospital based transfusion activities; "human application" means the use of tissues or cells on or in a human recipient and extracorporal applications; "inspection" means formal and objective control to identify problems in accordance with standards adopted to assess compliance with these regulations; "the Licensing Authority" means the Superintendent of Public Health as established in article 3(1); "the Medicines Authority" means the Licensing Authority established under the Medicines Act;

"organ" means a differentiated and vital part of the human body, formed by different tissues, that maintains its structure, vascularisation and capacity to develop physiological functions with an important level of autonomy; "processing" means all operations involved in the preparation, manipulation, preservation and packaging of tissues or cells intended for human applications;

"procurement" means a process by which tissues or cells are made available;

"preservation" means the use of chemical agents, alterations in tissue isolated physically or by other effective means, whilst awaiting a decision on their acceptance or rejection;

"serious adverse event" means in the case of blood and blood components, any untoward occurrence associated with the collection, testing, processing, storage, and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity; and in the case of tissues and cells means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or prolong, hospitalisation or morbidity; "serious adverse reaction" in the case of blood and blood components means an unintended response in donor or in patient associated with the collection or transfusion of blood and blood components that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity; in the case of tissues and cells it means an unintended response, including a communicable disease, in the donor or in the recipient associated with the procurement or human application of tissues and cells that is fatal, life-threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or morbidity;

"storage" means maintaining the product under appropriate controlled conditions until distribution;

"tissue" means all constituent parts of the human body formed by cells;

"tissues and cells establishment" means a tissue bank or a unit of a hospital or another body where activities of processing, preservation, storage or distribution of human tissues and cells are undertaken. It may also be responsible for procurement or testing of tissues and cells; "qualified health professional" includes a doctor, nurse and any health professional regulated by the Health Care Professions Act.