How we regulate blood

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This section provides an introduction to the Blood Regulations that became effective from 8 November 2005.

Blood bag

General

The Blood Safety and Quality Regulations 2005 No. 50 (external link) and The Blood Safety and Quality (Amendment) (No.2) Regulations 2005 No. 2898 (external link), 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. 2898PDF file (opens in new window) (64Kb)

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
  • 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
  • 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 (external link), 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-keeping requirements to “facilities” which may receive blood and blood components (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 (Fees Amendments) Regulations 2010 SI 554 - SI 2010/554 (external link) came into force on 1 April 2010 and implemented fee amendments.

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
  • 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
  • maintain records to ensure full traceability from donation to the point of delivery for not less than 30 years.

Further guidance is available on the UK Blood Transfusion & Tissue Transplantation Services site (external link)

Application form and guidance notes for a blood establishment authorisation

Application form for a blood establishment authorisationPDF file (opens in new window) (517Kb)

Guidance notes on the application form for a blood establishment authorisationPDF file (opens in new window) (594Kb)

For details of the fees payable, please see our fees section:

Fees for blood banks and other blood establishments

Blood Compliance Reports – 2014 submission

All 2014 compliance reports are in Microsoft Excel format. Please read the relevant guidance notes in full before completing the compliance report submission.

Hospital Blood Bank Compliance Reports 2014

Hospital Blood Bank Compliance Report v9 (2014)PDF file (opens in new window) (28Kb)

Hospital Blood Bank Compliance Report Guidance Notes for 2014PDF file (opens in new window) (2463Kb)
 

Blood Facility Compliance Reports 2014

Blood Facility Compliance Report v5 (2014)PDF file (opens in new window) (28Kb)

Blood Facility Compliance Report Guidance Notes for 2014PDF file (opens in new window) (2060Kb)

Addendum page for additional external supplied sites (please refer to Guidance Notes)

Distribution sites addendum page Word file (opens in new window) (342Kb)

Declaration page – Hospital Blood Bank and Blood Facility Compliance Reports

BCR Declaration Page Word file (opens in new window) (339Kb)

MHRA Guidance on Electronic Issue of Blood Components, May 2010

MHRA Guidance on Electronic IssuePDF file (opens in new window) (80Kb)

Management of the Outcome of Bacterial Monitoring Investigations

Management of the Outcome of Bacterial Monitoring InvestigationsPDF file (opens in new window) (160Kb)

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 seminarsPDF file (opens in new window) (45Kb)


Page last modified: 31 March 2014