SCHEDULES

SCHEDULE 2U.K.Amendment of the Human Medicines (Amendment etc.) (EU Exit) Regulations 2019

PART 10 U.K.Amendment of Part 11 (amendment of Part 11 (Pharmacovigilance))

126.  In regulation 158 (amendment of regulation 198 (post-authorisation safety studies: general provisions))—U.K.

(a)in paragraph (2), for “for “competent authorities” to the end substitute—

“(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.”.”;

(b)in paragraph (3)—

(i)in sub-paragraph (a) for “for “relevant competent authorities” to the end 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;”; and

(ii)in sub-paragraph (b) for “for “competent authorities” to the end substitute—

“(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.”.

Commencement Information