PART 4U.K.OBLIGATIONS OF THE AUTHORITY

[F1Inspection of third country premises etc [F2, Northern Ireland] U.K.

20B.—(1) Paragraph (2) applies where—

(a)qualifying tissues or cells are imported into [F3Northern Ireland] from a third country by an importing licence holder;

(b)the tissues or cells are distributed in an EEA stateF4...; and

(c)the competent authority in that state F5... (“the requesting authority”) requests the Authority to carry out any of the following activities—

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

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

(iii)to exercise the Authority’s power under paragraph 7(2) of Schedule 3 to the 2004 Act to revoke a licence held by an importing licence holder;

(iv)to exercise the Authority’s powers under paragraph 8(3) of Schedule 3 to the 2004 Act to vary a licence held by an importing licence holder; or

(v)other appropriate control measures.

(2) The Authority must carry out the activity in question specified in paragraph (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 pursuant to paragraph (2), the Authority must—

(a)make arrangements with the competent authority which made the request under paragraph (1) for that competent authority to participate in the inspection; or

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

(4) For the purposes of ascertaining whether qualifying tissues or cells imported into [F6Northern Ireland] from a third country meet standards of quality and safety equivalent to those laid down in these Regulations, the Authority may arrange for either or both of the following to be carried out on its behalf—

(a)an inspection of any third country premises; or

(b)an inspection of any relevant document 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 paragraph (2) or (4).

(6) Any inspection carried out in pursuance of paragraphs (2) and (4) must be carried out by a person authorised by the Authority for the purposes of this regulation.

(7) An inspection of any premises made under this regulation must include, in particular—

(a)the inspection of any equipment found on the premises;

(b)the inspection and copying of any relevant documents or records found on the premises; and

(c)the observation of any activity relevant to ascertaining whether qualifying tissues or cells imported from a third country meet standards of quality and safety equivalent to those laid down in these Regulations.

(8) In this regulation—

“qualifying tissues or cells” means tissues or cells intended for human application;

“relevant documents” mean documents relevant for the purposes of ascertaining whether qualifying tissues or cells imported from a third country meet standards of quality and safety equivalent to those laid down in these Regulations;

“requesting authority” has the meaning given in paragraph (1)(c).]

Textual Amendments

F1Regs. 20A-20C inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 5(2)