# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020, Paragraph 46


In regulation 63 (amendment of Schedule 11 (advice and representations))—
(a) for paragraph (2)(c) substitute—
“(c) for sub-paragraph (2) substitute—
“(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.”;”;
(b) for paragraph (4) substitute—
“(4) In paragraph 14(a) (application of Part 2), after “veterinary medicinal products” insert “or paragraph 1 of Schedule 10A”.”;
(c) for paragraph (7) substitute—
“(7) For paragraph 17 substitute—
“17. In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.”.”;
(d) for paragraph (8)(b)(ii) substitute—
“(ii) for sub-paragraph (2) substitute—
“(2) In relation to an application for a UKMA(NI) or THR(NI), this Part is subject to Part 4 of this Schedule.”; and”;
(e) for paragraph (9) substitute—
“(9) In Part 4 (exceptions to Schedule) omit paragraphs 31, 34, 35, 37 and 38.”.

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Source: https://www.legislation.gov.uk/ukdsi/2020/9780348213980/schedule/2/paragraph/46 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2020/schedule-2/paragraph-46
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.