Fees for blood establishments and hospital blood banks
Institutions and services provided
Fee £
Blood establishments
Application for authorisation
3,074
Substantial change to authorisation
518
Periodic fee
463
Daily rate for all inspections*
2,583
Annual haemovigilance fee (in respect of cost to MHRA of the operation of a system for receiving and assessing reports of serious adverse events and reactions)
492
Hospital blood banks and facilities 1
Daily rate for all inspections*
2,583
Annual haemovigilance fee (in respect of cost to MHRA of the operation of a sytem for receiving and assessing reports of serious adverse events and reactions)2
492
Annual compliance fee (in respect of the receipt and assessment of annual compliance reports submitted by hospital blood banks to the MHRA)3
683
Contract laboratories (that test blood or blood components on behalf of blood establishments or hospital blood banks)
Daily rate for inspections*
2,583
Notes:
'Facility' is defined in SI 2006/2013 as: “a hospital, any other facility or service owned or managed by a health service body, a care home, an independent clinic, a manufacturer, or a biomedical research institute.”
SI 2006/2013 exempts from payment of the annual haemovigilance fee a facility that has entered into an arrangement with a hospital blood bank for that hospital blood bank to report serious adverse events or reactions on the facility’s behalf.
The annual compliance fee is only payable by hospital blood banks, not by facilities. It is charged in addition to any inspection fee that may be payable.
*Notes for daily rate inspection fees:
There is a minimum fee of one day.
The inspection daily rate is calculated against a standard seven hour working day (excluding lunch breaks). Therefore the number of days spent on site for fees purposes will be calculated by dividing the number of hours on site by seven. Additional part days of less than 3.5 hours will be charged at half the daily rate and part days in excess of 3.5 hours will be charged at the full daily rate.
The daily rate fee includes pre-inspection preparation, travelling time, reporting of inspections and resolving issues. It also incorporates activities such as evaluation of compliance assessment report and other support functions and directly related overheads.
For inspections where two (or more) fully qualified inspectors undertake the inspection, the time on site for fees purposes will be the aggregated time for both inspectors.
For inspections attended by two or more inspectors, one or more of who is in training, only the cost of one inspector will be charged - the status of the inspectors should be made clear to the company at the start of the inspection.
