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The Human Fertilisation and Embryology (Quality and Safety) Regulations 2007
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- UK Statutory Instruments
- 2007 No. 1522
- PART 2
- Regulation 18
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Serious adverse events and serious adverse reactionsU.K.
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18. After section 15 (conditions of research licences), insert—
“15A.
Duties of the Authority in relation to serious adverse events and serious adverse reactions
(1) The Authority shall investigate serious adverse events and serious adverse reactions and take appropriate control measures.
(2) In investigating any serious adverse event or serious adverse reaction, the Authority shall, where it is appropriate to do so, arrange for—
(a)any premises to which a licence relates and any relevant third party premises to be inspected on its behalf, and
(b)a report on the inspection to be made to it.
(3) If the Authority receives a request from a competent authority in an EEA state other than the United Kingdom or in Gibraltar to carry out an inspection in relation to a serious adverse event or serious adverse reaction, the Authority must arrange for such an inspection to be carried out, for a report to be made of the inspection and for appropriate control measures to be taken.”.
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