16.—(1) 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—
(a)authorisations under regulation 4;
(b)the designation of responsible persons under regulation 6;
(c)notification of serious adverse events and serious adverse reactions by such establishments pursuant to [F1regulation 12B];
(d)inspections or requests for information under regulation 15;
(e)the operation, during the period from [F28th February 2005] to 7th November 2005, of blood establishments licensed under section 8 of the Medicines Act 1968.
(2) The Secretary of State shall keep such records of information which he receives from persons responsible for management of hospital blood banks [F3and facilities], or otherwise F4... relating to hospital blood banks [F5or facilities], as he considers appropriate and shall, in particular keep records relating to—
(a)notification of serious adverse events and serious adverse reactions pursuant to [F6regulation 12B];
(b)the information supplied by hospital blood banks pursuant to regulation 10;
(c)inspections or requests for information under regulation 15.
Textual Amendments
F1Words 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)
F2Words 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), 5
F3Words 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)
F4Word 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)
F5Words 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)
F6Words 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)