http://www.legislation.gov.uk/uksi/2005/50/regulation/16The Blood Safety and Quality Regulations 2005texttext/xmlenStatute Law DatabaseHEALTH AND SAFETY2024-05-16Expert Participation2024-03-21 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. Records to be kept by the Secretary of State161The Secretary of State shall keep such records of information which he receives from, or relating to, blood establishments as he considers appropriate and shall, in particular, keep records relating to—aauthorisations under regulation 4;bthe designation of responsible persons under regulation 6;cnotification of serious adverse events and serious adverse reactions by such establishments pursuant to regulation 12B;dinspections or requests for information under regulation 15;ethe operation, during the period from 8th February 2005 to 7th November 2005, of blood establishments licensed under section 8 of the Medicines Act 1968.2The Secretary of State shall keep such records of information which he receives from persons responsible for management of hospital blood banks and facilities, or otherwise ... relating to hospital blood banks or facilities, as he considers appropriate and shall, in particular keep records relating to—anotification of serious adverse events and serious adverse reactions pursuant to regulation 12B;bthe information supplied by hospital blood banks pursuant to regulation 10;cinspections or requests for information under regulation 15.Words in reg. 16(1)(e) substituted (8.4.2005) by The Blood Safety and Quality (Amendment) Regulations 2005 (S.I. 2005/1098), regs. 1(1), 5Words in reg. 16(2) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 10(a)Word in reg. 16(2) omitted (31.8.2006) by virtue of The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 10(b)Words in reg. 16(2) inserted (31.8.2006) by The Blood Safety and Quality (Amendment) Regulations 2006 (S.I. 2006/2013), regs. 1(1), 10(c)Words in reg. 16(1)(c) substituted (1.4.2007) by The Blood Safety and Quality (Amendment) Regulations 2007 (S.I. 2007/604), regs. 1(1), 3(a)Words in reg. 16(2)(a) substituted (1.4.2007) by The Blood Safety and Quality (Amendment) Regulations 2007 (S.I. 2007/604), regs. 1(1), 3(b)
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<Text>The Secretary of State shall keep such records of information which he receives from, or relating to, blood establishments as he considers appropriate and shall, in particular, keep records relating to—</Text>
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notification of serious adverse events and serious adverse reactions by such establishments pursuant to
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the operation, during the period from
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to 7
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November 2005, of blood establishments licensed under section 8 of the Medicines Act 1968.
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The Secretary of State shall keep such records of information which he receives from persons responsible for management of hospital blood banks
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, as he considers appropriate and shall, in particular keep records relating to—
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notification of serious adverse events and serious adverse reactions pursuant to
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<Para>
<Text>
Words in reg. 16(1)(e) substituted (8.4.2005) by
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,
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,
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<Text>
Words in reg. 16(2) inserted (31.8.2006) by
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,
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,
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</Text>
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<Text>
Word in reg. 16(2) omitted (31.8.2006) by virtue of
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,
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<Text>
Words in reg. 16(2) inserted (31.8.2006) by
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,
<CitationSubRef CitationRef="c4hdopcw4-00025" id="c4hdopcw4-00026" URI="http://www.legislation.gov.uk/id/uksi/2006/2013/regulation/1/1" SectionRef="regulation-1-1">regs. 1(1)</CitationSubRef>
,
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</Text>
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<Text>
Words in reg. 16(1)(c) substituted (1.4.2007) by
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,
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,
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<Text>
Words in reg. 16(2)(a) substituted (1.4.2007) by
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,
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,
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