158.—(1) Regulation 198 is amended as follows.
(2) In paragraph (2),
[F1(a)“the competent authorities” to the end becomes sub-paragraph (a);
(b)in sub-paragraph (a), at the end insert “and the licensing authority, where the product is subject to a marketing authorisation, traditional herbal registration or Article 126a authorisation for sale or supply in Northern Ireland;”
(c)after sub-paragraph (a) insert—
“(b)the licensing authority, where the product is subject to a marketing authorisation or traditional herbal registration for sale or supply in Great Britain only.”].
(3) In paragraph (3)—
(a)in sub-paragraph (c),
[F2(i)“for “the relevant competent authorities” substitute—
“(i)“for “the relevant competent authorities” substitute—
“(i)the relevant competent authorities and the licensing authority, where paragraph (2)(a) applies;
(ii)the licensing authority where paragraph (2)(b) applies,”
(ii)“any new information” to the end becomes full-out words;”]
(b)in sub-paragraph (d),
[F3(i)“the competent authorities of the EEA States in which the study was conducted” becomes paragraph (i);
(ii)in paragraph (i), after “the study was conducted” insert “and the licensing authority, where paragraph (2)(a) applies;”
(iii)after paragraph (i) insert—
“(ii)the licensing authority, where paragraph (2)(b) applies,”;
(iv)“before the end of the period” to the end becomes full-out words.]
Textual Amendments
F1Words in reg. 158(2) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(a)
F2Words in reg. 158(3)(a)(i) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(i)
F3Words in reg. 158(3) substituted (31.12.2020 immediately before IP completion day) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 126(b)(ii)
Commencement Information
I1Reg. 158 in force at 31.12.2020 on IP completion day (in accordance with 2020 c. 1, Sch. 5 para. 1(1)), see reg. 1