Blood Consultative Committee

Committee meetingThe primary objectives of the Committee are:

  1. to advise and provide  information to representatives of the national executive blood bodies, blood bank consultants, JPAC, SHOT, Haemophilia Society, Institute of Biomedical Sciences, British Society of Haematology, National Blood transfusion Committees, CPA, The wider Department of Health (DH) and other government departments with respect to other regulatory aspects of blood banks, blood establishments and blood processes
  2. to provide a forum for consultation and two-way discussion regarding proposed regulatory changes relating to the practical aspects of implementations
  3. to provide a forum to raise and take forward actions on strategic issues. 

At least two meetings will be held a year. the meeting will be chaired by a senior manager of the MHRA who will also provide the secretary. 

The meeting will be attended by MHRA representatives from the GMP inspectors, the policy group of the Inspections, Enforcement and Standards Division and the Devices Division. Other MHRA personnel as appropriate or the scheduled business. Up to two representatives each from the interested national bodies, SHOT, hospital blood banks, the Haemophilia Society, the wider DH and other government departments will be invited to attend.

Items to be discussed may include:

  1. regulatory and EU matters related to blood safety
  2. the performance and operation of the haemovigilance system and the Licensing Office
  3. interpretation of the principles of Good Manufacturing Practice (GMP) by the Competent Authority 
  4. compliance by blood banks and blood establishments (in general) with GMP and Good Distribution Practice (GDP) (feedback from inspections
  5. implementation of changes based upon newly emerging scientific evidence. 

A sub-committee will be set up under the auspices of the Blood Consultative Committee. This will review any detailed operations issues relating to SABRE. It will also discuss any technical points related to the reporting of serious adverse reactions and events. This will be a primary focus for discussions between the MHRA and SHOT.

The minutes of each meeting will be made available to all representatives. 

Page last modified: 04 February 2014