The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

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.”.