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The Blood Safety and Quality Regulations 2005

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This is the original version (as it was originally made).

Records to be kept by the Secretary of State

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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 regulation 7(1)(e);

(d)inspections or requests for information under regulation 15;

(e)the operation, during the period from 8th February 1005 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, or otherwise or relating to hospital blood banks, as he considers appropriate and shall, in particular keep records relating to—

(a)notification of serious adverse events and serious adverse reactions pursuant to regulation 9(1)(f);

(b)the information supplied by hospital blood banks pursuant to regulation 10;

(c)inspections or requests for information under regulation 15.

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