How we regulate blood

General
The Blood Safety and Quality Regulations 2005 No. 50 and The Blood Safety and Quality (Amendment) (No.2) Regulations 2005 No. 2898, became effective for the purposes of regulation on 8 November 2005.  An explanatory memorandum including a  Regulatory Impact Assessment for the Amendment Regulations are available:

› Explanatory memorandum to The Blood Safety and Quality (Amendment) (No.2) Regulations 2005 No. 2898

These Regulations implement  the requirements of the following EU Directives:

• Directive 2002/98/EC – setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components; and
  
• Directive 2004/33/EC – regarding certain technical requirements for blood and blood component.

Two further technical Directives were adopted by the European Commission on 30 September 2005 These are:

• Directive 2005/61/EC regarding traceability requirements and notification of serious adverse reactions and events; and
  
• Directive  2005/62/EC regarding Community standards and specifications relating to a quality system for blood establishments.

These Directives were transposed into UK legislation by the Blood Safety and Quality (Amendment) Regulations 2006 No. 2013, which came into force on 31 August 2006.

The Blood Safety and Quality Regulations apply to blood establishments and to hospital blood banks. The 2006 Amendment Regulations introduce requirements for a quality system in blood establishments and hospital blood banks. They also extend traceability and record-keepng requirements to “facilities” which may receive blood and blood components (i.e. care homes, independent clinics, hospitals and other NHS facilities and services, manufacturers of medicines and medical devices and biomedical research institutes).

› The Blood Safety and Quality (Amendment) Regulations 2006 No. 2013 (external link)
› The Blood Safety and Quality (Fees Amendment) Regulations 2008 No. 525 (external link) - SI 2008/525 came into force on 1 April 2008 and implemented fee amendments
› An Explanatory Memorandum, a Regulatory Impact Assessment and Transposition Table (external link)
› The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 No. 941 (external link) - SI 2008/941 came into force on 1 May and corrected minor errors in the principal Regulations

How does a manufacturer comply with the requirements?
As of 8 November 2005 blood establishments are required to:

• submit an application for a blood establishment authorisation;
• maintain a quality system based on the principles of good practice;
• notify the competent authority of any serious adverse events and serious adverse reactions  (haemovigilance /SABRE);
• ensure that all prospective donors of blood and blood components comply with the Regulations;
• maintain records to ensure full traceability from donation to the point of delivery  for no less than 30 years; and
• be subject to an inspection from the competent authority at least once every two years.

Hospital blood banks are required to:

• if they collect autologous blood and blood components submit an application for a blood establishment authorisation; 
• if they perform secondary processing of blood component (for example, irradiation, washing, splitting etc.) submit an application for a blood establishment authorisation;
• maintain a quality system based on the requirements of Directive 2005/62/EC;
• notify the competent authority of any serious adverse events and serious adverse reactions  (haemovigilance /SABRE);
• confirm compliance with the requirements of the directives by submitting an annual compliance report to the competent authority; and 
• maintain records to ensure full traceability from donation to the point of delivery for not less than 30 years.

Application form and guidance notes for a blood establishment authorisation
› Application form for a blood establishment authorisation
› Guidance notes on the application form for a blood establishment authorisation

An application fee of £2444 and inspection fee (£2698 to £8729 depending upon size of establishment) will be payable.

Hospital blood bank compliance report and instructions for completion
› Hospital blood bank compliance report (876Kb) - version 3 for reporting by 30 April 2008.

Questions and answers
The questions and answers from a series of  MHRA blood seminars held in September/October 2005 are available below:

› Questions and answers from the MHRA blood seminars