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—

  1. a

     in relation to the import of blood or blood components into Great Britain, a country other than the United Kingdom; and

  2. b

     in relation to the import of blood or blood components into Northern Ireland, a country other than Northern Ireland or a member State;