The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019

Amendment of the Blood Safety and Quality Regulations 2005

3.  In regulation 1, in paragraph (3)—

(a) 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(1);”;

““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;”;

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

(1)

https://www.edqm.eu/sites/default/files/goodpracticeguidelines-19th_edition_guide_preparation_use_qa_blood_components-december2016.pdf. Hard copies may be obtained from the Ministerial Correspondence and Public Enquiries Unit, Department of Health and Social Care, 39 Victoria Street, London SW1H 0EU.