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3. For regulation 3 substitute—
“3. In regulation 1, in paragraph (3)—
(a)after the definition of “qualified health professional” insert —
““quality system” means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management and, for this purpose, “quality management” means the co-ordinated activities to direct and control an organisation with regard to quality at all levels within the blood establishment or hospital blood bank;”;
(b)for the definition of “third country”, substitute—
““third country” means—
in relation to the import of blood or blood components into Great Britain, a country other than the United Kingdom; and
in relation to the import of blood or blood components into Northern Ireland, a country other than Northern Ireland or a member State;”.”.
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