Regulation 15 Amendment of regulation 3(11)

for paragraph (a) substitute—

“(a)

in paragraph (1)—

(i)

for sub-paragraph (a) substitute—

“(a)

any person in the United Kingdom carrying-on procurement, testing, processing, storage, distribution, import or export of tissue or cells intended for human application,”;

(ii)

for sub-paragraphs (c) and (d) (but not the words following sub-paragraph (d)), substitute—

“(c)

in relation to Northern Ireland, the competent authorities in EEA states; and

(d)

in relation to Northern Ireland, the European Commission,”;”;

for paragraph (b) substitute—

“(b)

for paragraph (3) substitute—

“(3)

In relation to Northern Ireland, the duty under paragraph (2) includes a duty to investigate any serious adverse event or serious adverse reaction which has occurred in Northern Ireland, and to carry out appropriate control measures, at the request of a competent authority in an EEA state.”.”.