Regulation 3 Amendment of the Blood Safety and Quality Regulations 2005

insert in the appropriate places the following definitions—

• ““good practice guidelines” means the 19th edition of the Good Practice Guidelines for Blood Establishments Required to Comply with Directive 2005/62/EC^f1;”;

• ““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;”;

in the definition of “third country” for “a Member State” substitute “the United Kingdom”.