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Human Fertilisation and Embryology Act 1990

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[F115BInspections of third country premises etcE+W+S+N.I.

(1)This section applies where—

(a)qualifying gametes or embryos are imported into the United Kingdom from a third country by an importing licensee,

(b)the gametes or embryos are distributed in an EEA state other than the United Kingdom or in Gibraltar, and

(c)the competent authority in that state or in Gibraltar requests the Authority to carry out any of the following activities—

(i)arranging for an inspection of any third country premises to be carried out on behalf of the Authority,

(ii)arranging for an inspection of any relevant documents held by a third country supplier to be carried out on behalf of the Authority,

(iii)exercising the Authority’s powers under section 18(2) to revoke a licence held by an importing licensee,

(iv)exercising the Authority’s powers under section 18A(3) to vary a licence held by an importing licensee,

(v)exercising the Authority’s powers under section 19C(1) to suspend a licence held by an importing licensee, and

(vi)other appropriate control measures.

(2)The Authority must carry out the activity in question in subsection (1)(c), unless it considers that it would be inappropriate to do so in the particular circumstances of the case.

(3)Before an inspection of any premises is carried out in pursuance of subsection (2), the Authority must—

(a)make arrangements with the competent authority which made the request under subsection (1) for it to participate in the inspection, or

(b)notify the competent authority which made the request under subsection (1) that the Authority has decided that it is not appropriate for it to participate in the inspection and give reasons for that decision.

(4)For the purposes of ascertaining whether qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act, the Authority may arrange for either or both of the following to be to be carried out on its behalf—

(a)an inspection of any third country premises,

(b)an inspection of any relevant documents held by a third country supplier.

(5)The Authority may arrange for a report to be made on any inspection carried out in pursuance of subsection (2) or (4).

(6)Any inspection carried out on behalf of the Authority in pursuance of subsection (2) or (4) must be carried out by a person authorised by the Authority to act for the purposes of this section.

(7)References in this section to carrying out an inspection of any premises include, in particular—

(a)inspecting any equipment found on the premises,

(b)inspecting and taking copies of any relevant documents or records found on the premises, and

(c)observing the carrying on of any activity relevant to ascertaining whether qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act.

(8)In this section, “relevant document” means a document relevant for the purposes of ascertaining whether qualifying gametes or embryos imported from a third country meet standards of quality and safety equivalent to those laid down in this Act.]

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Amendments (Textual)

F1Ss. 15B, 15C inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Fertilisation and Embryology (Amendment) Regulations 2018 (S.I. 2018/334), regs. 1(3), 5(2)

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