Regulation 3 I1F1

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;”;

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;”.