SCHEDULES
F1SCHEDULE 3BInspection, entry, search and seizure
F2Inspection of documents held by an importing licensee
Sch. 3B para. 1A 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(8)
1A
1
This paragraph applies F3in relation to Northern Ireland where—
a
qualifying gametes or embryos are imported from a third country by an importing licensee,
b
the gametes or embryos are distributed in an EEA state F4..., and
c
the competent authority in that state F5... requests the Authority to arrange for an inspection of any relevant documents held by an importing licensee to be carried out.
2
The Authority must arrange for an inspection of the documents in question to be carried out by a duly authorised person, unless the Authority considers that it would be inappropriate to do so in the particular circumstances of the case.
3
Where relevant documents are stored in any electronic form, a duly authorised person may require an importing licensee to make the documents available for inspection—
a
in a visible and legible form, or
b
in a form from which they can be readily produced in a visible and legible form.
4
A duly authorised person may take copies of any relevant documents inspected in pursuance of a requirement under this paragraph.
5
In this paragraph “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.
Sch. 3B inserted (1.10.2009) by Human Fertilisation and Embryology Act 2008 (c. 22), s. 68(2), Sch. 5; S.I. 2009/2232, art. 2(x)