# The Human Tissue (Quality and Safety for Human Application) (Amendment) (EU Exit) Regulations 2020, Regulation 15: Amendment of regulation 3(11)


In regulation 3(11)—
(a) 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,”;”;
(b) 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.”.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213027/regulation/15 (the official version)
Page: https://openlegislation.uk/draft-human-tissue-quality-and-safety-for-human-application-amendment-eu-exit-regulations-2020/regulation-15
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.