The Blood Safety and Quality Regulations 2005

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FeesU.K.

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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 [F1£3,381];

(b)in respect of an application for approval of a substantial change pursuant to regulation 4(10), the sum of [F2£570]; and

[F3(bb)in respect of the assessment by the Secretary of State of serious adverse events and serious adverse reactions notified by blood establishments, an annual haemovigilance fee calculated in accordance with paragraph (2A); and]

(c)in connection with the holding of an authorisation under regulation 3, an annual fee of the sum of [F4£509].

[F5(2A) The fee payable under paragraph (2)(bb) shall be—

(a)in respect of the reporting year ending on 31st March 2006, £156; and

(b)in respect of each subsequent reporting year, [F6£967]].

(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—

[F7(a)for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of [F8£3,552]; and

(b)for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of [F9£1,776], for each additional period of 3 hours and 30 minutes or less taken to make the inspection.]

[F10(3A) In respect of each reporting year in which a hospital blood bank has operated, the person who is responsible for management of that hospital blood bank shall pay to the Secretary of State a fee of [F11£751].

(3B) Subject to [F12paragraphs (3D) and (3E)], in respect of the assessment by the Secretary of State of serious adverse events and serious adverse reactions notified by hospital blood banks [F13or facilities], the person who is responsible for management of a hospital blood bank [F14or facility] shall pay to the Secretary of State an annual haemovigilance fee calculated in accordance with paragraph (3C).

(3C) The fee payable under paragraph (3C) shall be—

(b)in respect of the reporting year ending on 31st March 2006, £156; and

(c)in any other case, [F15£967].

(3D) No fee shall be payable under paragraph (3B) by a person responsible for the management of a hospital blood bank if that person is authorised as a blood establishment under these Regulations.]

[F16(3E) No fee shall be payable under paragraph (3B) by a person responsible for the management of a facility where the facility makes arrangements with a hospital blood bank, pursuant to regulation 12B(5) that the hospital blood bank will report serious adverse reactions and events to the Secretary of State on behalf of the facility.]

(4) Where the Secretary of State carries out an inspection of a hospital blood bank [F17or a facility] he may charge the person responsible for management of the hospital blood bank [F18or the facility] 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 [F19or facilities] in respect of inspections are—

[F20(a)for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of [F21£3,552]; and

(b)for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of [F22£1,776], for each additional period of 3 hours and 30 minutes or less taken to make the inspection.]

[F23(5A) Where the Secretary of State carries out an inspection of a contract laboratory, he may charge the person having control of that laboratory and that person shall, if so charged, pay to the Secretary of State a fee calculated in accordance with paragraph (5B).

(5B) Subject to paragraph (5C), the fee payable under paragraph (5A) shall be—

[F24(a)for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of [F25£3,552]; and

(b)for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of [F26£1,776], for each additional period of 3 hours and 30 minutes or less taken to make the inspection.]

(5C) Where an inspection referred to in paragraph (5A) takes place at the same time as an inspection by a person appointed by the Good Laboratory Practice Monitoring Authority under regulation 3(4) of the Good Laboratory Practice Regulations 1999, for the purposes of ascertaining whether the contract laboratory complies with the principles of good laboratory practice, the fee payable under paragraph (5A) shall be—

[F27(a)for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of [F28£3,552]; and

(b)for an inspection where the time taken to carry out the inspection at the site is more than 7 hours, the sum in sub-paragraph (a) and thereafter at the rate of [F29£1,776], for each additional period of 3 hours and 30 minutes or less taken to make the inspection.]

F30(5D) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .]

[F31(5E) The fee payable by a blood establishment or a person who is responsible for the management of a hospital blood bank who gives a notification under regulation 12(1) of its desire to make written representations to, or appear before and be heard by, a person appointed by the Secretary of State, is [F32£11,000].

(5F) The Secretary of State will refund to that person—

(a)60% of that fee if the person withdraws the notification two weeks before the commencement of the hearing before the person appointed;

(b)100% of that fee if, in respect of the hearing before a person appointed, the decision notified by the Secretary of State is—

(i)not to suspend or revoke, as the case may be, the authorisation pursuant to regulation 5;

(ii)to withdraw any notice served pursuant to regulation 4(8), 5 or 11; or

(iii)to overturn the refusal of authorisation or the imposition of any condition pursuant to regulation 4(5).]

(6) In this regulation—

[F33“contract laboratory” means a laboratory carrying out testing of blood or blood components on behalf of, and pursuant to a contractual arrangement with—

(a)

a blood establishment which is authorised under these Regulations; or

(b)

a person responsible for management of a hospital blood bank;]

F34...

[F35(6A) For the purposes of this regulation if an inspection is carried out by more than one inspector, the time taken by the Secretary of State to carry out the inspection is the aggregate of times taken by each inspector in carrying out the inspection at the site.]

(7) [F36Subject to paragraph (7A),] 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;

[F37(iia)any fee payable pursuant to paragraph (2)(bb) or (3B) shall be payable—

(aa)if it is payable in respect of the reporting year ending on 31st March 2006, on 31st December 2005, and

(bb)if it is payable in respect of any subsequent reporting year, on 30th April during that year;

(iib)the fee payable pursuant to paragraph (3A) shall be payable—

(aa)if it is payable in respect of the reporting year ending on 31st March 2006, on 31st December 2005, and

(bb)if it is payable in respect of any subsequent reporting year, on 30th April following the end of that year;]

[F38(iic)the fee payable pursuant to paragraph (5E) shall be payable at the time the notification is given;]

(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.

[F39(7A) In the case of a blood establishment granted an authorisation under regulation 4 before 8th November 2005, the periodic fee payable pursuant to paragraph (2)(c) shall be payable on 8th November 2006 and, while the blood establishment continues to be authorised to operate as such pursuant to these Regulations, annually thereafter.]

(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) [F40Save in respect of the fee payable under paragraph (5E), 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.

Textual Amendments

F1Sum in reg. 22(2)(a) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 17(2)(a)

F2Sum in reg. 22(2)(b) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 17(2)(b)

F3Reg. 22(2)(bb) inserted (8.11.2005) by The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898), regs. 1(1), 6(2)

F4Sum in reg. 22(2)(c) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 17(2)(c)

F5Reg. 22(2A) inserted (8.11.2005) by The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898), regs. 1(1), 6(3)

F6Sum in reg. 22(2A)(b) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 17(3)

F7Reg. 22(3)(a)(b) substituted for reg. 22(3)(a)-(f) (1.4.2008) by The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525), regs. 1(1), 2(4)

F8Sum in reg. 22(3)(a) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 17(4)(a)

F9Sum in reg. 22(3)(b) substituted (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 17(4)(b)