http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15The Blood Safety and Quality Regulations 2005texttext/xmlenStatute Law DatabaseHEALTH AND SAFETY2024-05-16Expert Participation2018-02-15 These Regulations impose safety and quality requirements on human blood collection and storage. The requirements apply to blood transfusion services in England, Scotland, Wales and Northern Ireland. Many of the provisions of the Regulations also apply to hospital blood banks. Fees221Blood establishments shall pay to the Secretary of State such fees as are payable in accordance with paragraphs (2) and (3).2The fees payable pursuant to paragraph (1) by blood establishments in relation to authorisation under regulation 3 are—ain respect of an application for authorisation pursuant to regulation 3, the sum of £3,074;bin respect of an application for approval of a substantial change pursuant to regulation 4(10), the sum of £518; andbbin 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); andcin connection with the holding of an authorisation under regulation 3, an annual fee of the sum of £463.2AThe fee payable under paragraph (2)(bb) shall be—ain respect of the reporting year ending on 31st March 2006, £156; andbin respect of each subsequent reporting year, £492.3Where 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—afor an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £2,583; andbfor 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 £1,292, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.3AIn 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 £683.3BSubject to paragraphs (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 or facilities, the person who is responsible for management of a hospital blood bank or facility shall pay to the Secretary of State an annual haemovigilance fee calculated in accordance with paragraph (3C).3CThe fee payable under paragraph (3C) shall be—bin respect of the reporting year ending on 31st March 2006, £156; andcin any other case, £492.3DNo 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.3ENo 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.4Where the Secretary of State carries out an inspection of a hospital blood bank or a facility he may charge the person responsible for management of the hospital blood bank or the facility and that person shall, if so charged, pay to the Secretary of State a fee calculated in accordance with paragraph (5).5The fees payable by hospital blood banks or facilities in respect of inspections are—afor an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £2,583; andbfor 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 £1,292, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.5AWhere 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).5BSubject to paragraph (5C), the fee payable under paragraph (5A) shall be—afor an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £2,583; andbfor 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 £1,292, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.5CWhere 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—afor an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of £2,583; andbfor 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 £1,292, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.5D. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5EThe 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 £10,000.5FThe Secretary of State will refund to that person—a60% of that fee if the person withdraws the notification two weeks before the commencement of the hearing before the person appointed;b100% of that fee if, in respect of the hearing before a person appointed, the decision notified by the Secretary of State is—inot to suspend or revoke, as the case may be, the authorisation pursuant to regulation 5;iito withdraw any notice served pursuant to regulation 4(8), 5 or 11; oriiito overturn the refusal of authorisation or the imposition of any condition pursuant to regulation 4(5).6In this regulation— “contract laboratory” means a laboratory carrying out testing of blood or blood components on behalf of, and pursuant to a contractual arrangement with—a blood establishment which is authorised under these Regulations; ora person responsible for management of a hospital blood bank; ............6AFor 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 Subject to paragraph (7A), any fee payable under this regulation shall be payable at the following times—ithe 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;iithe 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;iiaany fee payable pursuant to paragraph (2)(bb) or (3B) shall be payable—aaif it is payable in respect of the reporting year ending on 31st March 2006, on 31st December 2005, andbbif it is payable in respect of any subsequent reporting year, on 30th April during that year;iibthe fee payable pursuant to paragraph (3A) shall be payable—aaif it is payable in respect of the reporting year ending on 31st March 2006, on 31st December 2005, andbbif it is payable in respect of any subsequent reporting year, on 30th April following the end of that year;iicthe fee payable pursuant to paragraph (5E) shall be payable at the time the notification is given;iiiany 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.7AIn 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.8All 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 Save 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—awaive any fee or reduce any fee or part of a fee otherwise payable under this regulation; orbrefund the whole or part of any fee paid pursuant to this regulation.Reg. 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)Reg. 22(3A)-(3D) inserted (8.11.2005) by The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898), regs. 1(1), 6(4)Reg. 22(5A)-(5D) inserted (8.11.2005) by The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898), regs. 1(1), 6(5)Reg. 22(7A) inserted (8.11.2005) by The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898), regs. 1(1), 6(8)Reg. 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)Words in reg. 22(6) inserted (8.11.2005) by The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898), regs. 1(1), 6(6)Words in reg. 22(7) inserted (8.11.2005) by The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898), regs. 1(1), 6(7)(a)Reg. 22(7)(iia)(iib) inserted (8.11.2005) by The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898), regs. 1(1), 6(7)(b)Reg. 22(3E) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 14(b)Words in reg. 22(3B) substituted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 14(a)(i)Words in reg. 22(3B) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 14(a)(ii)Words in reg. 22(3B) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 14(a)(iii)Words in reg. 22(4) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 14(c)(i)Words in reg. 22(4) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 14(c)(ii)Words in reg. 22(5) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 14(d)Reg. 22(6A) inserted (1.4.2008) by The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525), regs. 1(1), 2(12)Reg. 22(5D) omitted (1.4.2008) by virtue of The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525), regs. 1(1), 2(10)Words in reg. 22(6) omitted (1.4.2008) by virtue of The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525), regs. 1(1), 2(11)Reg. 22(5)(a)(b) substituted for reg. 22(5)(a)-(c) (1.4.2008) by The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525), regs. 1(1), 2(7)Reg. 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)Reg. 22(5B)(a)(b) substituted for reg. 22(5B)(a)-(c) (1.4.2008) by The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525), regs. 1(1), 2(8)Reg. 22(5C)(a)(b) substituted for reg. 22(5C)(a)-(c) (1.4.2008) by The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525), regs. 1(1), 2(9)Reg. 22(5E)(5F) inserted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(10)Word in reg. 22(3A) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(5)Reg. 22(7)(iic) inserted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(11)Word in reg. 22(2)(a) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(2)(a)Word in reg. 22(2)(b) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(2)(b)Word in reg. 22(2)(c) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(2)(c)Word in reg. 22(2A)(b) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(3)Word in reg. 22(3)(a) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(4)(a)Word in reg. 22(3)(b) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(4)(b)Word in reg. 22(3C)(c) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(6)Word in reg. 22(5)(a) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(7)(a)Word in reg. 22(5)(b) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(7)(b)Word in reg. 22(5B)(a) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(8)(a)Word in reg. 22(5B)(b) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(8)(b)Word in reg. 22(5C)(a) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(9)(a)Word in reg. 22(5C)(b) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(9)(b)Words in reg. 22(9) substituted (1.4.2010) by The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554), regs. 1(1), 2(12)
This XML file does not appear to have any style information associated with it. The document tree is shown below.
<Legislation xmlns="http://www.legislation.gov.uk/namespaces/legislation" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50" NumberOfProvisions="109" RestrictEndDate="2018-04-01" xsi:schemaLocation="http://www.legislation.gov.uk/namespaces/legislation http://www.legislation.gov.uk/schema/legislation.xsd" SchemaVersion="1.0" RestrictStartDate="2018-02-15" RestrictExtent="E+W+S+N.I.">
<ukm:Metadata xmlns:dc="http://purl.org/dc/elements/1.1/" xmlns:dct="http://purl.org/dc/terms/" xmlns:atom="http://www.w3.org/2005/Atom" xmlns:ukm="http://www.legislation.gov.uk/namespaces/metadata">
<dc:identifier>http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15</dc:identifier>
<dc:title>The Blood Safety and Quality Regulations 2005</dc:title>
<dc:type>text</dc:type>
<dc:format>text/xml</dc:format>
<dc:language>en</dc:language>
<dc:publisher>Statute Law Database</dc:publisher>
<dc:subject scheme="SIheading">HEALTH AND SAFETY</dc:subject>
<dc:modified>2024-05-16</dc:modified>
<dc:contributor>Expert Participation</dc:contributor>
<dct:valid>2018-02-15</dct:valid>
<dc:description>These Regulations impose safety and quality requirements on human blood collection and storage. The requirements apply to blood transfusion services in England, Scotland, Wales and Northern Ireland. Many of the provisions of the Regulations also apply to hospital blood banks.</dc:description>
<atom:link rel="self" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15/data.xml" type="application/xml"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/resources" href="http://www.legislation.gov.uk/uksi/2005/50/resources" title="More Resources"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/memorandum" href="http://www.legislation.gov.uk/uksi/2005/50/memorandum" title="Explanatory Memorandum"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/memorandum/toc" href="http://www.legislation.gov.uk/uksi/2005/50/memorandum/contents" title="Explanatory Memorandum Table of Contents"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/act" href="http://www.legislation.gov.uk/uksi/2005/50/2018-02-15" title="whole act"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/introduction" href="http://www.legislation.gov.uk/uksi/2005/50/introduction/2018-02-15" title="introduction"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/signature" href="http://www.legislation.gov.uk/uksi/2005/50/signature/2018-02-15" title="signature"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/note" href="http://www.legislation.gov.uk/uksi/2005/50/note/2018-02-15" title="note"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/body" href="http://www.legislation.gov.uk/uksi/2005/50/body/2018-02-15" title="body"/>
<atom:link rel="http://www.legislation.gov.uk/def/navigation/schedules" href="http://www.legislation.gov.uk/uksi/2005/50/schedules/2018-02-15" title="schedules"/>
<atom:link rel="alternate" type="application/rdf+xml" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15/data.rdf" title="RDF/XML"/>
<atom:link rel="alternate" type="application/akn+xml" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15/data.akn" title="AKN"/>
<atom:link rel="alternate" type="application/xhtml+xml" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15/data.xht" title="HTML snippet"/>
<atom:link rel="alternate" type="text/html" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15/data.htm" title="Website (XHTML) Default View"/>
<atom:link rel="alternate" type="text/csv" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15/data.csv" title="CSV"/>
<atom:link rel="alternate" type="application/pdf" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15/data.pdf" title="PDF"/>
<atom:link rel="alternate" type="application/akn+xhtml" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15/data.html" title="HTML5 snippet"/>
<atom:link rel="http://purl.org/dc/terms/tableOfContents" hreflang="en" href="http://www.legislation.gov.uk/uksi/2005/50/contents/2018-02-15" title="Table of Contents"/>
<atom:link rel="http://purl.org/dc/terms/replaces" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2009-04-01" title="2009-04-01"/>
<atom:link rel="http://purl.org/dc/terms/isReplacedBy" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2023-04-01" title="2023-04-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/made" title="made"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2005-02-08" title="2005-02-08"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2005-11-08" title="2005-11-08"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2006-08-31" title="2006-08-31"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2007-04-01" title="2007-04-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2008-04-01" title="2008-04-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2009-04-01" title="2009-04-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2010-04-01" title="2010-04-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2023-04-01" title="2023-04-01"/>
<atom:link rel="http://purl.org/dc/terms/hasVersion" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/22" title="current"/>
<atom:link rel="up" href="http://www.legislation.gov.uk/uksi/2005/50/2018-02-15" title="Entire legislation"/>
<atom:link rel="prev" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/21/2018-02-15" title="Provision; Regulation 21"/>
<atom:link rel="prevInForce" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/21/2018-02-15" title="Provision; Regulation 21"/>
<atom:link rel="next" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/23/2018-02-15" title="Provision; Regulation 23"/>
<atom:link rel="nextInForce" href="http://www.legislation.gov.uk/uksi/2005/50/regulation/23/2018-02-15" title="Provision; Regulation 23"/>
<ukm:SecondaryMetadata>
<ukm:DocumentClassification>
<ukm:DocumentCategory Value="secondary"/>
<ukm:DocumentMainType Value="UnitedKingdomStatutoryInstrument"/>
<ukm:DocumentStatus Value="revised"/>
<ukm:DocumentMinorType Value="regulation"/>
</ukm:DocumentClassification>
<ukm:Year Value="2005"/>
<ukm:Number Value="50"/>
<ukm:Made Date="2005-01-13"/>
<ukm:Laid Date="2005-01-18" Class="UnitedKingdomParliament"/>
<ukm:ISBN Value="0110516222"/>
<ukm:UnappliedEffects>
<ukm:UnappliedEffect AffectingProvisions="reg. 14" AffectingEffectsExtent="E+W+S+N.I." AffectingURI="http://www.legislation.gov.uk/id/uksi/2019/4" Type="words substituted" AffectingYear="2019" AffectedClass="UnitedKingdomStatutoryInstrument" AffectingClass="UnitedKingdomStatutoryInstrument" URI="http://www.legislation.gov.uk/id/effect/key-b371f98490cc831c95dd4c8b1bdccbb3" Row="216" RequiresApplied="false" AffectingNumber="4" Modified="2021-11-26T16:20:09Z" Notes="This amendment not applied to legislation.gov.uk. S.I. 2019/4, reg. 14 substituted immediately before IP completion day by S.I. 2020/1304, regs. 1, 14" AffectedNumber="50" EffectId="key-b371f98490cc831c95dd4c8b1bdccbb3" AppendedCommentary="2020 c. 1, Sch. 5 para. 1(1)" AffectedURI="http://www.legislation.gov.uk/id/uksi/2005/50" AffectedProvisions="Sch. Pt. 3 para. 1" Comments="IP completion day" AffectedYear="2005">
<ukm:AffectedTitle>The Blood Safety and Quality Regulations 2005</ukm:AffectedTitle>
<ukm:AffectedProvisions>
<ukm:Section Ref="schedule-part-3" URI="http://www.legislation.gov.uk/id/uksi/2005/50/schedule/part/3">Sch. Pt. 3 </ukm:Section>
<ukm:Section xmlns:err="http://www.legislation.gov.uk/namespaces/error" Ref="schedule-part-3-paragraph-1" URI="http://www.legislation.gov.uk/id/uksi/2005/50/schedule/part/3/paragraph/1" err:Ref="Section missing in legislation" Missing="true">para. 1</ukm:Section>
</ukm:AffectedProvisions>
<ukm:AffectingTitle>The Blood Safety and Quality (Amendment) (EU Exit) Regulations 2019</ukm:AffectingTitle>
<ukm:AffectingProvisions>
<ukm:Section Ref="regulation-14" URI="http://www.legislation.gov.uk/id/uksi/2019/4/regulation/14">reg. 14</ukm:Section>
</ukm:AffectingProvisions>
<ukm:CommencementAuthority>
<ukm:Section Ref="regulation-1" URI="http://www.legislation.gov.uk/id/uksi/2019/4/regulation/1">reg. 1</ukm:Section>
</ukm:CommencementAuthority>
<ukm:InForceDates>
<ukm:InForce Date="2020-12-31" Qualification="wholly in force"/>
</ukm:InForceDates>
</ukm:UnappliedEffect>
</ukm:UnappliedEffects>
</ukm:SecondaryMetadata>
<ukm:Notes>
<ukm:Note IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/notes"/>
<ukm:Alternatives>
<ukm:Alternative Date="2008-12-08" URI="http://www.legislation.gov.uk/uksi/2005/50/pdfs/uksiem_20050050_en.pdf" Title="Explanatory Memorandum"/>
</ukm:Alternatives>
</ukm:Notes>
<ukm:Alternatives>
<ukm:Alternative Date="2008-12-08" URI="http://www.legislation.gov.uk/uksi/2005/50/pdfs/uksi_20050050_en.pdf" Title="Print Version"/>
</ukm:Alternatives>
<ukm:Statistics>
<ukm:TotalParagraphs Value="144"/>
<ukm:BodyParagraphs Value="29"/>
<ukm:ScheduleParagraphs Value="115"/>
<ukm:AttachmentParagraphs Value="0"/>
<ukm:TotalImages Value="7"/>
</ukm:Statistics>
</ukm:Metadata>
<Secondary>
<Body DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/body/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/body" NumberOfProvisions="29" RestrictExtent="E+W+S+N.I." RestrictStartDate="2018-02-15">
<P1group RestrictEndDate="2023-04-01" RestrictStartDate="2010-04-01" RestrictExtent="E+W+S+N.I.">
<Title>Fees</Title>
<P1 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22" id="regulation-22">
<Pnumber>22</Pnumber>
<P1para>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/1/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/1" id="regulation-22-1">
<Pnumber>1</Pnumber>
<P2para>
<Text>Blood establishments shall pay to the Secretary of State such fees as are payable in accordance with paragraphs (2) and (3).</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/2" id="regulation-22-2">
<Pnumber>2</Pnumber>
<P2para>
<Text>The fees payable pursuant to paragraph (1) by blood establishments in relation to authorisation under regulation 3 are—</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2/a/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/2/a" id="regulation-22-2-a">
<Pnumber>a</Pnumber>
<P3para>
<Text>
in respect of an application for authorisation pursuant to regulation 3, the sum of
<Substitution ChangeId="key-6d1c3b989ab54d11ddef5bf5d2b342fe-1619741818350" CommentaryRef="key-6d1c3b989ab54d11ddef5bf5d2b342fe">£3,074</Substitution>
;
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2/b/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/2/b" id="regulation-22-2-b">
<Pnumber>b</Pnumber>
<P3para>
<Text>
in respect of an application for approval of a substantial change pursuant to regulation 4(10), the sum of
<Substitution ChangeId="key-92cb923479e4e55bd524b6efebcbea67-1619741872689" CommentaryRef="key-92cb923479e4e55bd524b6efebcbea67">£518</Substitution>
; and
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2/bb/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/2/bb" id="regulation-22-2-bb">
<Pnumber>
<Addition ChangeId="key-a9aab3f42d4f5b2ab90f87b276a9642e-1615463639804" CommentaryRef="key-a9aab3f42d4f5b2ab90f87b276a9642e">bb</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-a9aab3f42d4f5b2ab90f87b276a9642e-1615463639804" CommentaryRef="key-a9aab3f42d4f5b2ab90f87b276a9642e">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</Addition>
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2/c/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/2/c" id="regulation-22-2-c">
<Pnumber>c</Pnumber>
<P3para>
<Text>
in connection with the holding of an authorisation under regulation 3, an annual fee of the sum of
<Substitution ChangeId="key-360bf6029729b1bc8716780d0900c4a2-1619741934067" CommentaryRef="key-360bf6029729b1bc8716780d0900c4a2">£463</Substitution>
.
</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2A/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/2A" id="regulation-22-2A">
<Pnumber>
<Addition ChangeId="key-9d7e51083208865b196abc581c8d7ef8-1615463484974" CommentaryRef="key-9d7e51083208865b196abc581c8d7ef8">2A</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-9d7e51083208865b196abc581c8d7ef8-1615463484974" CommentaryRef="key-9d7e51083208865b196abc581c8d7ef8">The fee payable under paragraph (2)(bb) shall be—</Addition>
</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2A/a/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/2A/a" id="regulation-22-2A-a">
<Pnumber>
<Addition ChangeId="key-9d7e51083208865b196abc581c8d7ef8-1615463484974" CommentaryRef="key-9d7e51083208865b196abc581c8d7ef8">a</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-9d7e51083208865b196abc581c8d7ef8-1615463484974" CommentaryRef="key-9d7e51083208865b196abc581c8d7ef8">in respect of the reporting year ending on 31st March 2006, £156; and</Addition>
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/2A/b/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/2A/b" id="regulation-22-2A-b">
<Pnumber>
<Addition ChangeId="key-9d7e51083208865b196abc581c8d7ef8-1615463484974" CommentaryRef="key-9d7e51083208865b196abc581c8d7ef8">b</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-9d7e51083208865b196abc581c8d7ef8-1615463484974" CommentaryRef="key-9d7e51083208865b196abc581c8d7ef8">in respect of each subsequent reporting year, </Addition>
<Addition ChangeId="key-9d7e51083208865b196abc581c8d7ef8-1615463484974" CommentaryRef="key-9d7e51083208865b196abc581c8d7ef8">
<Substitution ChangeId="key-c6b737078a442868cfdd021aa8416e69-1619741986960" CommentaryRef="key-c6b737078a442868cfdd021aa8416e69">£492</Substitution>
</Addition>
<Addition ChangeId="key-9d7e51083208865b196abc581c8d7ef8-1615463484974" CommentaryRef="key-9d7e51083208865b196abc581c8d7ef8">.</Addition>
</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3" id="regulation-22-3">
<Pnumber>3</Pnumber>
<P2para>
<Text>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—</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3/a/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3/a" id="regulation-22-3-a">
<Pnumber>
<Substitution ChangeId="key-2ec688f41735187ded0984f642f8c87c-1619733410619" CommentaryRef="key-2ec688f41735187ded0984f642f8c87c">a</Substitution>
</Pnumber>
<P3para>
<Text>
<Substitution ChangeId="key-2ec688f41735187ded0984f642f8c87c-1619733410619" CommentaryRef="key-2ec688f41735187ded0984f642f8c87c">for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of </Substitution>
<Substitution ChangeId="key-2ec688f41735187ded0984f642f8c87c-1619733410619" CommentaryRef="key-2ec688f41735187ded0984f642f8c87c">
<Substitution ChangeId="key-8624785726a6c25b12c5749fbf10ee06-1619742058289" CommentaryRef="key-8624785726a6c25b12c5749fbf10ee06">£2,583</Substitution>
</Substitution>
<Substitution ChangeId="key-2ec688f41735187ded0984f642f8c87c-1619733410619" CommentaryRef="key-2ec688f41735187ded0984f642f8c87c">; and</Substitution>
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3/b/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3/b" id="regulation-22-3-b">
<Pnumber>
<Substitution ChangeId="key-2ec688f41735187ded0984f642f8c87c-1619733410619" CommentaryRef="key-2ec688f41735187ded0984f642f8c87c">b</Substitution>
</Pnumber>
<P3para>
<Text>
<Substitution ChangeId="key-2ec688f41735187ded0984f642f8c87c-1619733410619" CommentaryRef="key-2ec688f41735187ded0984f642f8c87c">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 </Substitution>
<Substitution ChangeId="key-2ec688f41735187ded0984f642f8c87c-1619733410619" CommentaryRef="key-2ec688f41735187ded0984f642f8c87c">
<Substitution ChangeId="key-307d6cafa3c221a2dc94f6c4cd95df79-1619742202116" CommentaryRef="key-307d6cafa3c221a2dc94f6c4cd95df79">£1,292</Substitution>
</Substitution>
<Substitution ChangeId="key-2ec688f41735187ded0984f642f8c87c-1619733410619" CommentaryRef="key-2ec688f41735187ded0984f642f8c87c">, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.</Substitution>
</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3A/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3A" id="regulation-22-3A">
<Pnumber>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">3A</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">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 </Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">
<Substitution ChangeId="key-9ca489e3f9512b6ce856e9fb60a2ce5b-1619741578397" CommentaryRef="key-9ca489e3f9512b6ce856e9fb60a2ce5b">£683</Substitution>
</Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">.</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3B/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3B" id="regulation-22-3B">
<Pnumber>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">3B</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">Subject to </Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">
<Substitution ChangeId="key-37e4f0f76655cd53f3a7bdd441502196-1617119330310" CommentaryRef="key-37e4f0f76655cd53f3a7bdd441502196">paragraphs (3D) and (3E)</Substitution>
</Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">, in respect of the assessment by the Secretary of State of serious adverse events and serious adverse reactions notified by hospital blood banks </Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">
<Addition ChangeId="key-26add4cfbaf94d8621f8503503c432a6-1617119370270" CommentaryRef="key-26add4cfbaf94d8621f8503503c432a6">or facilities</Addition>
</Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">, the person who is responsible for management of a hospital blood bank </Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">
<Addition ChangeId="key-d9fe8d86246ed69927710bc0519ee215-1617119425262" CommentaryRef="key-d9fe8d86246ed69927710bc0519ee215">or facility</Addition>
</Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b"> shall pay to the Secretary of State an annual haemovigilance fee calculated in accordance with paragraph (3C).</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3C/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3C" id="regulation-22-3C">
<Pnumber>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">3C</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">The fee payable under paragraph (3C) shall be—</Addition>
</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3C/b/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3C/b" id="regulation-22-3C-b">
<Pnumber>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">b</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">in respect of the reporting year ending on 31st March 2006, £156; and</Addition>
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3C/c/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3C/c" id="regulation-22-3C-c">
<Pnumber>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">c</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">in any other case, </Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">
<Substitution ChangeId="key-866f4c05d0c01de575b7b0c08abd3193-1619742261744" CommentaryRef="key-866f4c05d0c01de575b7b0c08abd3193">£492</Substitution>
</Addition>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">.</Addition>
</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3D/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3D" id="regulation-22-3D">
<Pnumber>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">3D</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-581fbc6cc9b8a7dc8376396e9b4d2f0b-1615463537354" CommentaryRef="key-581fbc6cc9b8a7dc8376396e9b4d2f0b">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.</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/3E/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/3E" id="regulation-22-3E">
<Pnumber>
<Addition ChangeId="key-462ac9dfcb5ae7e4e27e9b7da6d09dce-1617119287685" CommentaryRef="key-462ac9dfcb5ae7e4e27e9b7da6d09dce">3E</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-462ac9dfcb5ae7e4e27e9b7da6d09dce-1617119287685" CommentaryRef="key-462ac9dfcb5ae7e4e27e9b7da6d09dce">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.</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/4/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/4" id="regulation-22-4">
<Pnumber>4</Pnumber>
<P2para>
<Text>
Where the Secretary of State carries out an inspection of a hospital blood bank
<Addition ChangeId="key-285be336449123d48384ab67a572269d-1617119474081" CommentaryRef="key-285be336449123d48384ab67a572269d">or a facility</Addition>
he may charge the person responsible for management of the hospital blood bank
<Addition ChangeId="key-6d47ebf8b6ddb60d99b3ea93a25d23c0-1617119521124" CommentaryRef="key-6d47ebf8b6ddb60d99b3ea93a25d23c0">or the facility</Addition>
and that person shall, if so charged, pay to the Secretary of State a fee calculated in accordance with paragraph (5).
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5" id="regulation-22-5">
<Pnumber>5</Pnumber>
<P2para>
<Text>
The fees payable by hospital blood banks
<Addition ChangeId="key-b3ea4be2944670eb567f34e16a76345a-1617119555500" CommentaryRef="key-b3ea4be2944670eb567f34e16a76345a">or facilities</Addition>
in respect of inspections are—
</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5/a/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5/a" id="regulation-22-5-a">
<Pnumber>
<Substitution ChangeId="key-f5a08d4d5ba59898b2f6b44585a6a4d2-1619733013049" CommentaryRef="key-f5a08d4d5ba59898b2f6b44585a6a4d2">a</Substitution>
</Pnumber>
<P3para>
<Text>
<Substitution ChangeId="key-f5a08d4d5ba59898b2f6b44585a6a4d2-1619733013049" CommentaryRef="key-f5a08d4d5ba59898b2f6b44585a6a4d2">for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of </Substitution>
<Substitution ChangeId="key-f5a08d4d5ba59898b2f6b44585a6a4d2-1619733013049" CommentaryRef="key-f5a08d4d5ba59898b2f6b44585a6a4d2">
<Substitution ChangeId="key-e61e2f98358069dcb0408a3cfeb2070e-1619742333897" CommentaryRef="key-e61e2f98358069dcb0408a3cfeb2070e">£2,583</Substitution>
</Substitution>
<Substitution ChangeId="key-f5a08d4d5ba59898b2f6b44585a6a4d2-1619733013049" CommentaryRef="key-f5a08d4d5ba59898b2f6b44585a6a4d2">; and</Substitution>
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5/b/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5/b" id="regulation-22-5-b">
<Pnumber>
<Substitution ChangeId="key-f5a08d4d5ba59898b2f6b44585a6a4d2-1619733013049" CommentaryRef="key-f5a08d4d5ba59898b2f6b44585a6a4d2">b</Substitution>
</Pnumber>
<P3para>
<Text>
<Substitution ChangeId="key-f5a08d4d5ba59898b2f6b44585a6a4d2-1619733013049" CommentaryRef="key-f5a08d4d5ba59898b2f6b44585a6a4d2">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 </Substitution>
<Substitution ChangeId="key-f5a08d4d5ba59898b2f6b44585a6a4d2-1619733013049" CommentaryRef="key-f5a08d4d5ba59898b2f6b44585a6a4d2">
<Substitution ChangeId="key-d758d4f600bf609b99e7bf3b24676057-1619742387454" CommentaryRef="key-d758d4f600bf609b99e7bf3b24676057">£1,292</Substitution>
</Substitution>
<Substitution ChangeId="key-f5a08d4d5ba59898b2f6b44585a6a4d2-1619733013049" CommentaryRef="key-f5a08d4d5ba59898b2f6b44585a6a4d2">, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.</Substitution>
</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5A/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5A" id="regulation-22-5A">
<Pnumber>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">5A</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">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).</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5B/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5B" id="regulation-22-5B">
<Pnumber>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">5B</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">Subject to paragraph (5C), the fee payable under paragraph (5A) shall be—</Addition>
</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5B/a/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5B/a" id="regulation-22-5B-a">
<Pnumber>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-deeed61ab33d6430f73e12e29b143f14-1619733569883" CommentaryRef="key-deeed61ab33d6430f73e12e29b143f14">a</Substitution>
</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-deeed61ab33d6430f73e12e29b143f14-1619733569883" CommentaryRef="key-deeed61ab33d6430f73e12e29b143f14">for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of </Substitution>
</Addition>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-deeed61ab33d6430f73e12e29b143f14-1619733569883" CommentaryRef="key-deeed61ab33d6430f73e12e29b143f14">
<Substitution ChangeId="key-f5a066b18805cdaa1e355c3307982236-1619742445822" CommentaryRef="key-f5a066b18805cdaa1e355c3307982236">£2,583</Substitution>
</Substitution>
</Addition>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-deeed61ab33d6430f73e12e29b143f14-1619733569883" CommentaryRef="key-deeed61ab33d6430f73e12e29b143f14">; and</Substitution>
</Addition>
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5B/b/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5B/b" id="regulation-22-5B-b">
<Pnumber>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-deeed61ab33d6430f73e12e29b143f14-1619733569883" CommentaryRef="key-deeed61ab33d6430f73e12e29b143f14">b</Substitution>
</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-deeed61ab33d6430f73e12e29b143f14-1619733569883" CommentaryRef="key-deeed61ab33d6430f73e12e29b143f14">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 </Substitution>
</Addition>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-deeed61ab33d6430f73e12e29b143f14-1619733569883" CommentaryRef="key-deeed61ab33d6430f73e12e29b143f14">
<Substitution ChangeId="key-b031f46ad9196a9cf53393d67c0873b9-1619742494339" CommentaryRef="key-b031f46ad9196a9cf53393d67c0873b9">£1,292</Substitution>
</Substitution>
</Addition>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-deeed61ab33d6430f73e12e29b143f14-1619733569883" CommentaryRef="key-deeed61ab33d6430f73e12e29b143f14">, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.</Substitution>
</Addition>
</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5C/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5C" id="regulation-22-5C">
<Pnumber>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">5C</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">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—</Addition>
</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5C/a/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5C/a" id="regulation-22-5C-a">
<Pnumber>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-f0dce7b193eb3cd586f84021b6c74e3d-1619733711799" CommentaryRef="key-f0dce7b193eb3cd586f84021b6c74e3d">a</Substitution>
</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-f0dce7b193eb3cd586f84021b6c74e3d-1619733711799" CommentaryRef="key-f0dce7b193eb3cd586f84021b6c74e3d">for an inspection where the time taken to carry out the inspection at the site is not more than 7 hours, the sum of </Substitution>
</Addition>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-f0dce7b193eb3cd586f84021b6c74e3d-1619733711799" CommentaryRef="key-f0dce7b193eb3cd586f84021b6c74e3d">
<Substitution ChangeId="key-3393641d09c9f6160fa4d68f46719187-1619742547031" CommentaryRef="key-3393641d09c9f6160fa4d68f46719187">£2,583</Substitution>
</Substitution>
</Addition>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-f0dce7b193eb3cd586f84021b6c74e3d-1619733711799" CommentaryRef="key-f0dce7b193eb3cd586f84021b6c74e3d">; and</Substitution>
</Addition>
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5C/b/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5C/b" id="regulation-22-5C-b">
<Pnumber>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-f0dce7b193eb3cd586f84021b6c74e3d-1619733711799" CommentaryRef="key-f0dce7b193eb3cd586f84021b6c74e3d">b</Substitution>
</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-f0dce7b193eb3cd586f84021b6c74e3d-1619733711799" CommentaryRef="key-f0dce7b193eb3cd586f84021b6c74e3d">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 </Substitution>
</Addition>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-f0dce7b193eb3cd586f84021b6c74e3d-1619733711799" CommentaryRef="key-f0dce7b193eb3cd586f84021b6c74e3d">
<Substitution ChangeId="key-8a0dc927a792811df1021f81cf9519b5-1619742601089" CommentaryRef="key-8a0dc927a792811df1021f81cf9519b5">£1,292</Substitution>
</Substitution>
</Addition>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">
<Substitution ChangeId="key-f0dce7b193eb3cd586f84021b6c74e3d-1619733711799" CommentaryRef="key-f0dce7b193eb3cd586f84021b6c74e3d">, for each additional period of 3 hours and 30 minutes or less taken to make the inspection.</Substitution>
</Addition>
</Text>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5D/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5D" id="regulation-22-5D">
<Pnumber>
<CommentaryRef Ref="key-1ab27f86bbdb7e754cd975850f1e7faf"/>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">5D</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-7679e28a882567e773daf16dcce9dd5d-1615463579884" CommentaryRef="key-7679e28a882567e773daf16dcce9dd5d">. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5E/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5E" id="regulation-22-5E">
<Pnumber>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">5E</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">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 £10,000.</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5F/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5F" id="regulation-22-5F">
<Pnumber>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">5F</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">The Secretary of State will refund to that person—</Addition>
</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5F/a/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5F/a" id="regulation-22-5F-a">
<Pnumber>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">a</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">60% of that fee if the person withdraws the notification two weeks before the commencement of the hearing before the person appointed;</Addition>
</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5F/b/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5F/b" id="regulation-22-5F-b">
<Pnumber>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">b</Addition>
</Pnumber>
<P3para>
<Text>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">100% of that fee if, in respect of the hearing before a person appointed, the decision notified by the Secretary of State is—</Addition>
</Text>
<P4 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5F/b/i/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5F/b/i" id="regulation-22-5F-b-i">
<Pnumber>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">i</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">not to suspend or revoke, as the case may be, the authorisation pursuant to regulation 5;</Addition>
</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5F/b/ii/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5F/b/ii" id="regulation-22-5F-b-ii">
<Pnumber>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">ii</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">to withdraw any notice served pursuant to regulation 4(8), 5 or 11; or</Addition>
</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/5F/b/iii/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/5F/b/iii" id="regulation-22-5F-b-iii">
<Pnumber>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">iii</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="key-a03d4473f3a0a2597a024cd81862f1ce-1619741505733" CommentaryRef="key-a03d4473f3a0a2597a024cd81862f1ce">to overturn the refusal of authorisation or the imposition of any condition pursuant to regulation 4(5).</Addition>
</Text>
</P4para>
</P4>
</P3para>
</P3>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/6/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/6" id="regulation-22-6">
<Pnumber>6</Pnumber>
<P2para>
<Text>In this regulation—</Text>
</P2para>
<UnorderedList Decoration="none" Class="Definition">
<ListItem>
<Para>
<Text>
<Addition ChangeId="key-d02ddc9ab14fbeffd6cf5f210d1f14a9-1615463733204" CommentaryRef="key-d02ddc9ab14fbeffd6cf5f210d1f14a9">“contract laboratory” means a laboratory carrying out testing of blood or blood components on behalf of, and pursuant to a contractual arrangement with—</Addition>
</Text>
<OrderedList Decoration="parens" Type="alpha">
<ListItem>
<Para>
<Text>
<Addition ChangeId="key-d02ddc9ab14fbeffd6cf5f210d1f14a9-1615463733204" CommentaryRef="key-d02ddc9ab14fbeffd6cf5f210d1f14a9">a blood establishment which is authorised under these Regulations; or</Addition>
</Text>
</Para>
</ListItem>
<ListItem>
<Para>
<Text>
<Addition ChangeId="key-d02ddc9ab14fbeffd6cf5f210d1f14a9-1615463733204" CommentaryRef="key-d02ddc9ab14fbeffd6cf5f210d1f14a9">a person responsible for management of a hospital blood bank;</Addition>
</Text>
</Para>
</ListItem>
</OrderedList>
</Para>
</ListItem>
<ListItem>
<Para>
<Text>
<CommentaryRef Ref="key-1b9ab4ab7c9c77c30dc8bd997f8dd3ce"/>
...
</Text>
</Para>
</ListItem>
<ListItem>
<Para>
<Text>
<CommentaryRef Ref="key-1b9ab4ab7c9c77c30dc8bd997f8dd3ce"/>
...
</Text>
</Para>
</ListItem>
<ListItem>
<Para>
<Text>
<CommentaryRef Ref="key-1b9ab4ab7c9c77c30dc8bd997f8dd3ce"/>
...
</Text>
</Para>
</ListItem>
<ListItem>
<Para>
<Text>
<CommentaryRef Ref="key-1b9ab4ab7c9c77c30dc8bd997f8dd3ce"/>
...
</Text>
</Para>
</ListItem>
</UnorderedList>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/6A/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/6A" id="regulation-22-6A">
<Pnumber>
<Addition ChangeId="key-2c077f54d1d512b52f6839c3798383c2-1619732677897" CommentaryRef="key-2c077f54d1d512b52f6839c3798383c2">6A</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-2c077f54d1d512b52f6839c3798383c2-1619732677897" CommentaryRef="key-2c077f54d1d512b52f6839c3798383c2">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.</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7" id="regulation-22-7">
<Pnumber>7</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-23899c5e1f46af88e30c3057feec8820-1615463779675" CommentaryRef="key-23899c5e1f46af88e30c3057feec8820">Subject to paragraph (7A),</Addition>
any fee payable under this regulation shall be payable at the following times—
</Text>
<P4 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/i/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/i" id="regulation-22-7-i">
<Pnumber>i</Pnumber>
<P4para>
<Text>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;</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/ii/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/ii" id="regulation-22-7-ii">
<Pnumber>ii</Pnumber>
<P4para>
<Text>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;</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/iia/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/iia" id="regulation-22-7-iia">
<Pnumber>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">iia</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">any fee payable pursuant to paragraph (2)(bb) or (3B) shall be payable—</Addition>
</Text>
<P5 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/iia/aa/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/iia/aa" id="regulation-22-7-iia-aa">
<Pnumber>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">aa</Addition>
</Pnumber>
<P5para>
<Text>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">if it is payable in respect of the reporting year ending on 31st March 2006, on 31st December 2005, and</Addition>
</Text>
</P5para>
</P5>
<P5 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/iia/bb/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/iia/bb" id="regulation-22-7-iia-bb">
<Pnumber>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">bb</Addition>
</Pnumber>
<P5para>
<Text>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">if it is payable in respect of any subsequent reporting year, on 30th April during that year;</Addition>
</Text>
</P5para>
</P5>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/iib/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/iib" id="regulation-22-7-iib">
<Pnumber>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">iib</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">the fee payable pursuant to paragraph (3A) shall be payable—</Addition>
</Text>
<P5 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/iib/aa/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/iib/aa" id="regulation-22-7-iib-aa">
<Pnumber>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">aa</Addition>
</Pnumber>
<P5para>
<Text>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">if it is payable in respect of the reporting year ending on 31st March 2006, on 31st December 2005, and</Addition>
</Text>
</P5para>
</P5>
<P5 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/iib/bb/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/iib/bb" id="regulation-22-7-iib-bb">
<Pnumber>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">bb</Addition>
</Pnumber>
<P5para>
<Text>
<Addition ChangeId="key-687a245af3aca1a938739ac3ef9160f6-1615463850355" CommentaryRef="key-687a245af3aca1a938739ac3ef9160f6">if it is payable in respect of any subsequent reporting year, on 30th April following the end of that year;</Addition>
</Text>
</P5para>
</P5>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/iic/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/iic" id="regulation-22-7-iic">
<Pnumber>
<Addition ChangeId="key-009b53bbb81ae6f5ece2070608477483-1619741759622" CommentaryRef="key-009b53bbb81ae6f5ece2070608477483">iic</Addition>
</Pnumber>
<P4para>
<Text>
<Addition ChangeId="key-009b53bbb81ae6f5ece2070608477483-1619741759622" CommentaryRef="key-009b53bbb81ae6f5ece2070608477483">the fee payable pursuant to paragraph (5E) shall be payable at the time the notification is given;</Addition>
</Text>
</P4para>
</P4>
<P4 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7/iii/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7/iii" id="regulation-22-7-iii">
<Pnumber>iii</Pnumber>
<P4para>
<Text>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.</Text>
</P4para>
</P4>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/7A/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/7A" id="regulation-22-7A">
<Pnumber>
<Addition ChangeId="key-d55aa3522eaee2d172d7bc187e5aa96f-1615463607714" CommentaryRef="key-d55aa3522eaee2d172d7bc187e5aa96f">7A</Addition>
</Pnumber>
<P2para>
<Text>
<Addition ChangeId="key-d55aa3522eaee2d172d7bc187e5aa96f-1615463607714" CommentaryRef="key-d55aa3522eaee2d172d7bc187e5aa96f">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.</Addition>
</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/8/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/8" id="regulation-22-8">
<Pnumber>8</Pnumber>
<P2para>
<Text>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.</Text>
</P2para>
</P2>
<P2 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/9/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/9" id="regulation-22-9">
<Pnumber>9</Pnumber>
<P2para>
<Text>
<Substitution ChangeId="key-ed69c3fd807cb02ac084a95662d6678c-1619742671594" CommentaryRef="key-ed69c3fd807cb02ac084a95662d6678c">Save in respect of the fee payable under paragraph (5E), the Secretary of State</Substitution>
may in exceptional circumstances where it appears to him to be in the interests of safety or otherwise appropriate to do so—
</Text>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/9/a/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/9/a" id="regulation-22-9-a">
<Pnumber>a</Pnumber>
<P3para>
<Text>waive any fee or reduce any fee or part of a fee otherwise payable under this regulation; or</Text>
</P3para>
</P3>
<P3 DocumentURI="http://www.legislation.gov.uk/uksi/2005/50/regulation/22/9/b/2018-02-15" IdURI="http://www.legislation.gov.uk/id/uksi/2005/50/regulation/22/9/b" id="regulation-22-9-b">
<Pnumber>b</Pnumber>
<P3para>
<Text>refund the whole or part of any fee paid pursuant to this regulation.</Text>
</P3para>
</P3>
</P2para>
</P2>
</P1para>
</P1>
</P1group>
</Body>
</Secondary>
<Commentaries>
<Commentary id="key-9d7e51083208865b196abc581c8d7ef8" Type="F">
<Para>
<Text>
Reg. 22(2A) inserted (8.11.2005) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2005/2898" id="c3r25fjl4-00007" Class="UnitedKingdomStatutoryInstrument" Year="2005" Number="2898" Title="The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005">The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898)</Citation>
,
<CitationSubRef id="c3r25fjl4-00008" CitationRef="c3r25fjl4-00007" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c3r25fjl4-00009" CitationRef="c3r25fjl4-00007" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/6/3" SectionRef="regulation-6-3" Operative="true">6(3)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-581fbc6cc9b8a7dc8376396e9b4d2f0b" Type="F">
<Para>
<Text>
Reg. 22(3A)-(3D) inserted (8.11.2005) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2005/2898" id="c3r25fjl4-00016" Class="UnitedKingdomStatutoryInstrument" Year="2005" Number="2898" Title="The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005">The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898)</Citation>
,
<CitationSubRef id="c3r25fjl4-00017" CitationRef="c3r25fjl4-00016" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c3r25fjl4-00018" CitationRef="c3r25fjl4-00016" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/6/4" SectionRef="regulation-6-4" Operative="true">6(4)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-7679e28a882567e773daf16dcce9dd5d" Type="F">
<Para>
<Text>
Reg. 22(5A)-(5D) inserted (8.11.2005) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2005/2898" id="c3r25fjl4-00025" Class="UnitedKingdomStatutoryInstrument" Year="2005" Number="2898" Title="The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005">The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898)</Citation>
,
<CitationSubRef id="c3r25fjl4-00026" CitationRef="c3r25fjl4-00025" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c3r25fjl4-00027" CitationRef="c3r25fjl4-00025" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/6/5" SectionRef="regulation-6-5" Operative="true">6(5)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-d55aa3522eaee2d172d7bc187e5aa96f" Type="F">
<Para>
<Text>
Reg. 22(7A) inserted (8.11.2005) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2005/2898" id="c3r25fjl4-00034" Class="UnitedKingdomStatutoryInstrument" Year="2005" Number="2898" Title="The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005">The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898)</Citation>
,
<CitationSubRef id="c3r25fjl4-00035" CitationRef="c3r25fjl4-00034" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c3r25fjl4-00036" CitationRef="c3r25fjl4-00034" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/6/8" SectionRef="regulation-6-8" Operative="true">6(8)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-a9aab3f42d4f5b2ab90f87b276a9642e" Type="F">
<Para>
<Text>
Reg. 22(2)(bb) inserted (8.11.2005) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2005/2898" id="c3r25fjl4-00043" Class="UnitedKingdomStatutoryInstrument" Year="2005" Number="2898" Title="The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005">The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898)</Citation>
,
<CitationSubRef id="c3r25fjl4-00044" CitationRef="c3r25fjl4-00043" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c3r25fjl4-00045" CitationRef="c3r25fjl4-00043" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/6/2" SectionRef="regulation-6-2" Operative="true">6(2)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-d02ddc9ab14fbeffd6cf5f210d1f14a9" Type="F">
<Para>
<Text>
Words in reg. 22(6) inserted (8.11.2005) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2005/2898" id="c3r25fjl4-00052" Class="UnitedKingdomStatutoryInstrument" Year="2005" Number="2898" Title="The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005">The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898)</Citation>
,
<CitationSubRef id="c3r25fjl4-00053" CitationRef="c3r25fjl4-00052" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c3r25fjl4-00054" CitationRef="c3r25fjl4-00052" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/6/6" SectionRef="regulation-6-6" Operative="true">6(6)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-23899c5e1f46af88e30c3057feec8820" Type="F">
<Para>
<Text>
Words in reg. 22(7) inserted (8.11.2005) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2005/2898" id="c3r25fjl4-00061" Class="UnitedKingdomStatutoryInstrument" Year="2005" Number="2898" Title="The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005">The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898)</Citation>
,
<CitationSubRef id="c3r25fjl4-00062" CitationRef="c3r25fjl4-00061" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c3r25fjl4-00063" CitationRef="c3r25fjl4-00061" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/6/7/a" SectionRef="regulation-6-7-a" Operative="true">6(7)(a)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-687a245af3aca1a938739ac3ef9160f6" Type="F">
<Para>
<Text>
Reg. 22(7)(iia)(iib) inserted (8.11.2005) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2005/2898" id="c3r25fjl4-00071" Class="UnitedKingdomStatutoryInstrument" Year="2005" Number="2898" Title="The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005">The Blood Safety and Quality (Amendment) (No. 2) Regulations 2005 (S.I. 2005/2898)</Citation>
,
<CitationSubRef id="c3r25fjl4-00072" CitationRef="c3r25fjl4-00071" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c3r25fjl4-00073" CitationRef="c3r25fjl4-00071" URI="http://www.legislation.gov.uk/id/uksi/2005/2898/regulation/6/7/b" SectionRef="regulation-6-7-b" Operative="true">6(7)(b)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-462ac9dfcb5ae7e4e27e9b7da6d09dce" Type="F">
<Para>
<Text>
Reg. 22(3E) inserted (31.8.2006) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2006/2013" id="c4he1g4b4-00007" Class="UnitedKingdomStatutoryInstrument" Year="2006" Number="2013" Title="The Blood Safety and Quality (Amendment) Regulations 2006">The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013)</Citation>
,
<CitationSubRef id="c4he1g4b4-00008" CitationRef="c4he1g4b4-00007" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c4he1g4b4-00009" CitationRef="c4he1g4b4-00007" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/14/b" SectionRef="regulation-14-b" Operative="true">14(b)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-37e4f0f76655cd53f3a7bdd441502196" Type="F">
<Para>
<Text>
Words in reg. 22(3B) substituted (31.8.2006) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2006/2013" id="c4he1g4b4-00016" Class="UnitedKingdomStatutoryInstrument" Year="2006" Number="2013" Title="The Blood Safety and Quality (Amendment) Regulations 2006">The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013)</Citation>
,
<CitationSubRef id="c4he1g4b4-00017" CitationRef="c4he1g4b4-00016" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c4he1g4b4-00018" CitationRef="c4he1g4b4-00016" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/14/a/i" SectionRef="regulation-14-a-i" Operative="true">14(a)(i)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-26add4cfbaf94d8621f8503503c432a6" Type="F">
<Para>
<Text>
Words in reg. 22(3B) inserted (31.8.2006) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2006/2013" id="c4he1g4b4-00025" Class="UnitedKingdomStatutoryInstrument" Year="2006" Number="2013" Title="The Blood Safety and Quality (Amendment) Regulations 2006">The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013)</Citation>
,
<CitationSubRef id="c4he1g4b4-00026" CitationRef="c4he1g4b4-00025" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c4he1g4b4-00027" CitationRef="c4he1g4b4-00025" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/14/a/ii" SectionRef="regulation-14-a-ii" Operative="true">14(a)(ii)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-d9fe8d86246ed69927710bc0519ee215" Type="F">
<Para>
<Text>
Words in reg. 22(3B) inserted (31.8.2006) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2006/2013" id="c4he1g4b4-00034" Class="UnitedKingdomStatutoryInstrument" Year="2006" Number="2013" Title="The Blood Safety and Quality (Amendment) Regulations 2006">The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013)</Citation>
,
<CitationSubRef id="c4he1g4b4-00035" CitationRef="c4he1g4b4-00034" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c4he1g4b4-00036" CitationRef="c4he1g4b4-00034" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/14/a/iii" SectionRef="regulation-14-a-iii" Operative="true">14(a)(iii)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-285be336449123d48384ab67a572269d" Type="F">
<Para>
<Text>
Words in reg. 22(4) inserted (31.8.2006) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2006/2013" id="c4he1g4b4-00043" Class="UnitedKingdomStatutoryInstrument" Year="2006" Number="2013" Title="The Blood Safety and Quality (Amendment) Regulations 2006">The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013)</Citation>
,
<CitationSubRef id="c4he1g4b4-00044" CitationRef="c4he1g4b4-00043" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c4he1g4b4-00045" CitationRef="c4he1g4b4-00043" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/14/c/i" SectionRef="regulation-14-c-i" Operative="true">14(c)(i)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-6d47ebf8b6ddb60d99b3ea93a25d23c0" Type="F">
<Para>
<Text>
Words in reg. 22(4) inserted (31.8.2006) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2006/2013" id="c4he1g4b4-00052" Class="UnitedKingdomStatutoryInstrument" Year="2006" Number="2013" Title="The Blood Safety and Quality (Amendment) Regulations 2006">The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013)</Citation>
,
<CitationSubRef id="c4he1g4b4-00053" CitationRef="c4he1g4b4-00052" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c4he1g4b4-00054" CitationRef="c4he1g4b4-00052" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/14/c/ii" SectionRef="regulation-14-c-ii" Operative="true">14(c)(ii)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-b3ea4be2944670eb567f34e16a76345a" Type="F">
<Para>
<Text>
Words in reg. 22(5) inserted (31.8.2006) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2006/2013" id="c4he1g4b4-00061" Class="UnitedKingdomStatutoryInstrument" Year="2006" Number="2013" Title="The Blood Safety and Quality (Amendment) Regulations 2006">The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013)</Citation>
,
<CitationSubRef id="c4he1g4b4-00062" CitationRef="c4he1g4b4-00061" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c4he1g4b4-00063" CitationRef="c4he1g4b4-00061" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/14/d" SectionRef="regulation-14-d" Operative="true">14(d)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-2c077f54d1d512b52f6839c3798383c2" Type="F">
<Para>
<Text>
Reg. 22(6A) inserted (1.4.2008) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2008/525" id="c5pq734d4-00007" Class="UnitedKingdomStatutoryInstrument" Year="2008" Number="525" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2008">The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525)</Citation>
,
<CitationSubRef id="c5pq734d4-00008" CitationRef="c5pq734d4-00007" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pq734d4-00009" CitationRef="c5pq734d4-00007" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/2/12" SectionRef="regulation-2-12" Operative="true">2(12)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-1ab27f86bbdb7e754cd975850f1e7faf" Type="F">
<Para>
<Text>
Reg. 22(5D) omitted (1.4.2008) by virtue of
<Citation URI="http://www.legislation.gov.uk/id/uksi/2008/525" id="c5pq734d4-00023" Class="UnitedKingdomStatutoryInstrument" Year="2008" Number="525" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2008">The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525)</Citation>
,
<CitationSubRef id="c5pq734d4-00024" CitationRef="c5pq734d4-00023" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pq734d4-00025" CitationRef="c5pq734d4-00023" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/2/10" SectionRef="regulation-2-10" Operative="true">2(10)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-1b9ab4ab7c9c77c30dc8bd997f8dd3ce" Type="F">
<Para>
<Text>
Words in reg. 22(6) omitted (1.4.2008) by virtue of
<Citation URI="http://www.legislation.gov.uk/id/uksi/2008/525" id="c5pq734d4-00032" Class="UnitedKingdomStatutoryInstrument" Year="2008" Number="525" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2008">The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525)</Citation>
,
<CitationSubRef id="c5pq734d4-00033" CitationRef="c5pq734d4-00032" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pq734d4-00034" CitationRef="c5pq734d4-00032" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/2/11" SectionRef="regulation-2-11" Operative="true">2(11)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-f5a08d4d5ba59898b2f6b44585a6a4d2" Type="F">
<Para>
<Text>
Reg. 22(5)(a)(b) substituted for reg. 22(5)(a)-(c) (1.4.2008) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2008/525" id="c5pq734d4-00041" Class="UnitedKingdomStatutoryInstrument" Year="2008" Number="525" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2008">The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525)</Citation>
,
<CitationSubRef id="c5pq734d4-00042" CitationRef="c5pq734d4-00041" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pq734d4-00043" CitationRef="c5pq734d4-00041" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/2/7" SectionRef="regulation-2-7" Operative="true">2(7)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-2ec688f41735187ded0984f642f8c87c" Type="F">
<Para>
<Text>
Reg. 22(3)(a)(b) substituted for reg. 22(3)(a)-(f) (1.4.2008) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2008/525" id="c5pq734d4-00086" Class="UnitedKingdomStatutoryInstrument" Year="2008" Number="525" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2008">The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525)</Citation>
,
<CitationSubRef id="c5pq734d4-00087" CitationRef="c5pq734d4-00086" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pq734d4-00088" CitationRef="c5pq734d4-00086" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/2/4" SectionRef="regulation-2-4" Operative="true">2(4)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-deeed61ab33d6430f73e12e29b143f14" Type="F">
<Para>
<Text>
Reg. 22(5B)(a)(b) substituted for reg. 22(5B)(a)-(c) (1.4.2008) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2008/525" id="c5pq734d4-00104" Class="UnitedKingdomStatutoryInstrument" Year="2008" Number="525" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2008">The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525)</Citation>
,
<CitationSubRef id="c5pq734d4-00105" CitationRef="c5pq734d4-00104" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pq734d4-00106" CitationRef="c5pq734d4-00104" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/2/8" SectionRef="regulation-2-8" Operative="true">2(8)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-f0dce7b193eb3cd586f84021b6c74e3d" Type="F">
<Para>
<Text>
Reg. 22(5C)(a)(b) substituted for reg. 22(5C)(a)-(c) (1.4.2008) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2008/525" id="c5pq734d4-00113" Class="UnitedKingdomStatutoryInstrument" Year="2008" Number="525" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2008">The Blood Safety and Quality (Fees Amendment) Regulations 2008 (S.I. 2008/525)</Citation>
,
<CitationSubRef id="c5pq734d4-00114" CitationRef="c5pq734d4-00113" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pq734d4-00115" CitationRef="c5pq734d4-00113" URI="http://www.legislation.gov.uk/id/uksi/2008/525/regulation/2/9" SectionRef="regulation-2-9" Operative="true">2(9)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-a03d4473f3a0a2597a024cd81862f1ce" Type="F">
<Para>
<Text>
Reg. 22(5E)(5F) inserted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00008" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00009" CitationRef="c5pvfkya4-00008" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00010" CitationRef="c5pvfkya4-00008" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/10" SectionRef="regulation-2-10" Operative="true">2(10)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-9ca489e3f9512b6ce856e9fb60a2ce5b" Type="F">
<Para>
<Text>
Word in reg. 22(3A) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00017" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00018" CitationRef="c5pvfkya4-00017" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00019" CitationRef="c5pvfkya4-00017" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/5" SectionRef="regulation-2-5" Operative="true">2(5)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-009b53bbb81ae6f5ece2070608477483" Type="F">
<Para>
<Text>
Reg. 22(7)(iic) inserted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00026" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00027" CitationRef="c5pvfkya4-00026" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00028" CitationRef="c5pvfkya4-00026" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/11" SectionRef="regulation-2-11" Operative="true">2(11)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-6d1c3b989ab54d11ddef5bf5d2b342fe" Type="F">
<Para>
<Text>
Word in reg. 22(2)(a) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00035" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00036" CitationRef="c5pvfkya4-00035" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00037" CitationRef="c5pvfkya4-00035" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/2/a" SectionRef="regulation-2-2-a" Operative="true">2(2)(a)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-92cb923479e4e55bd524b6efebcbea67" Type="F">
<Para>
<Text>
Word in reg. 22(2)(b) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00044" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00045" CitationRef="c5pvfkya4-00044" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00046" CitationRef="c5pvfkya4-00044" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/2/b" SectionRef="regulation-2-2-b" Operative="true">2(2)(b)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-360bf6029729b1bc8716780d0900c4a2" Type="F">
<Para>
<Text>
Word in reg. 22(2)(c) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00053" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00054" CitationRef="c5pvfkya4-00053" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00055" CitationRef="c5pvfkya4-00053" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/2/c" SectionRef="regulation-2-2-c" Operative="true">2(2)(c)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-c6b737078a442868cfdd021aa8416e69" Type="F">
<Para>
<Text>
Word in reg. 22(2A)(b) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00062" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00063" CitationRef="c5pvfkya4-00062" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00064" CitationRef="c5pvfkya4-00062" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/3" SectionRef="regulation-2-3" Operative="true">2(3)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-8624785726a6c25b12c5749fbf10ee06" Type="F">
<Para>
<Text>
Word in reg. 22(3)(a) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00071" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00072" CitationRef="c5pvfkya4-00071" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00073" CitationRef="c5pvfkya4-00071" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/4/a" SectionRef="regulation-2-4-a" Operative="true">2(4)(a)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-307d6cafa3c221a2dc94f6c4cd95df79" Type="F">
<Para>
<Text>
Word in reg. 22(3)(b) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00080" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00081" CitationRef="c5pvfkya4-00080" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00082" CitationRef="c5pvfkya4-00080" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/4/b" SectionRef="regulation-2-4-b" Operative="true">2(4)(b)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-866f4c05d0c01de575b7b0c08abd3193" Type="F">
<Para>
<Text>
Word in reg. 22(3C)(c) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00089" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00090" CitationRef="c5pvfkya4-00089" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00091" CitationRef="c5pvfkya4-00089" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/6" SectionRef="regulation-2-6" Operative="true">2(6)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-e61e2f98358069dcb0408a3cfeb2070e" Type="F">
<Para>
<Text>
Word in reg. 22(5)(a) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00098" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00099" CitationRef="c5pvfkya4-00098" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00100" CitationRef="c5pvfkya4-00098" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/7/a" SectionRef="regulation-2-7-a" Operative="true">2(7)(a)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-d758d4f600bf609b99e7bf3b24676057" Type="F">
<Para>
<Text>
Word in reg. 22(5)(b) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00107" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00108" CitationRef="c5pvfkya4-00107" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00109" CitationRef="c5pvfkya4-00107" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/7/b" SectionRef="regulation-2-7-b" Operative="true">2(7)(b)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-f5a066b18805cdaa1e355c3307982236" Type="F">
<Para>
<Text>
Word in reg. 22(5B)(a) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00116" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00117" CitationRef="c5pvfkya4-00116" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00118" CitationRef="c5pvfkya4-00116" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/8/a" SectionRef="regulation-2-8-a" Operative="true">2(8)(a)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-b031f46ad9196a9cf53393d67c0873b9" Type="F">
<Para>
<Text>
Word in reg. 22(5B)(b) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00125" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00126" CitationRef="c5pvfkya4-00125" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00127" CitationRef="c5pvfkya4-00125" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/8/b" SectionRef="regulation-2-8-b" Operative="true">2(8)(b)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-3393641d09c9f6160fa4d68f46719187" Type="F">
<Para>
<Text>
Word in reg. 22(5C)(a) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00134" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00135" CitationRef="c5pvfkya4-00134" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00136" CitationRef="c5pvfkya4-00134" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/9/a" SectionRef="regulation-2-9-a" Operative="true">2(9)(a)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-8a0dc927a792811df1021f81cf9519b5" Type="F">
<Para>
<Text>
Word in reg. 22(5C)(b) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00143" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00144" CitationRef="c5pvfkya4-00143" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00145" CitationRef="c5pvfkya4-00143" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/9/b" SectionRef="regulation-2-9-b" Operative="true">2(9)(b)</CitationSubRef>
</Text>
</Para>
</Commentary>
<Commentary id="key-ed69c3fd807cb02ac084a95662d6678c" Type="F">
<Para>
<Text>
Words in reg. 22(9) substituted (1.4.2010) by
<Citation URI="http://www.legislation.gov.uk/id/uksi/2010/554" id="c5pvfkya4-00152" Class="UnitedKingdomStatutoryInstrument" Year="2010" Number="554" Title="The Blood Safety and Quality (Fees Amendment) Regulations 2010">The Blood Safety and Quality (Fees Amendment) Regulations 2010 (S.I. 2010/554)</Citation>
,
<CitationSubRef id="c5pvfkya4-00153" CitationRef="c5pvfkya4-00152" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
<CitationSubRef id="c5pvfkya4-00154" CitationRef="c5pvfkya4-00152" URI="http://www.legislation.gov.uk/id/uksi/2010/554/regulation/2/12" SectionRef="regulation-2-12" Operative="true">2(12)</CitationSubRef>
</Text>
</Para>
</Commentary>
</Commentaries>
</Legislation>