The Blood Safety and Quality Regulations 2005

Fees

22.—(1) Blood establishments shall pay to the Secretary of State such fees as are payable in accordance with paragraphs (2) and (3).

(2) The fees payable pursuant to paragraph (1) by blood establishments in relation to authorisation under regulation 3 are—

(a) in respect of an application for authorisation pursuant to regulation 3, the sum of £2,444;

(b) in respect of an application for approval of a substantial change pursuant to regulation 4(10), the sum of £400; and

(c) in connection with the holding of an authorisation under regulation 3, an annual fee of the sum of £304.

(3) Where the Secretary of State carries out an inspection at a site of a blood establishment he may charge the establishment and that establishment shall, if so charged, pay to the Secretary of State a fee calculated in accordance with the following sub-paragraphs—

(a) for a regular inspection of a major site, the sum of £8,729;

(b) for a regular inspection of a standard site, the sum of £5,557;

(c) for a regular inspection of a minor site, the sum of £2,698;

(d) for any other inspection, where the inspector spends at least two hours but no more than one day at the site, £1,518;

(e) for any other where an inspector spends more than one day but less than three days at the inspection site, £4,048; or

(f) for any other inspection where the inspector spends three days or more at the site, £7,590.

(4) Where the Secretary of State carries out an inspection of a hospital blood bank he may charge the person responsible for management of the hospital blood bank and that person shall, if so charged, pay to the Secretary of State a fee calculated in accordance with paragraph (5).

(5) The fees payable by hospital blood banks in respect of inspections are—

(a) where an inspector spends at least two hours but no more than one day at the inspection site, £759;

(b) where an inspector spends more than one day but less than three days at the inspection site, £2024; or

(c) where the inspector spends three days or more at the inspection site, £3795.

(6) In this regulation—

“major site” means a site at which 60 or more persons are involved in processing and quality assurance of blood or blood components;

“minor site” means a site at which fewer than 10 persons are involved in processing and quality assurance of blood or blood components;

“regular inspection” means an inspection of blood establishment pursuant to regulation 15(1);

“standard site” means a site at which at least 10 but fewer than 60 people are involved in processing and quality assurance of blood or blood components.

(7) Any fee payable under this regulation shall be payable at the following times—

(i) the fee payable pursuant to paragraph (2)(a) in respect of an application for authorisation to operate a blood establishment, and the fee payable pursuant to paragraph (2)(b) in respect of an application to make a substantial change, shall, in each case, be payable at the time the application is made;

(ii) the periodic fee payable pursuant to paragraph (2)(c) shall be payable on the first anniversary of the grant by the Secretary of State of authorisation to operate as a blood establishment, and whilst the blood establishment continues to be authorised to operate as such pursuant to these Regulations, annually thereafter;

(iii) any other fee payable under this regulation shall be payable within fourteen days following written notice from the Secretary of State requiring payment of the fee.

(8) All unpaid sums due by way of, or on account of, any fees payable under this regulation shall be recoverable as debts due to the Crown.

(9) The Secretary of State may in exceptional circumstances where it appears to him to be in the interests of safety or otherwise appropriate to do so—

(a) waive any fee or reduce any fee or part of a fee otherwise payable under this regulation; or

(b) refund the whole or part of any fee paid pursuant to this regulation.