Regulation 158 Amendment of regulation 198 (post-authorisation safety studies: general provisions)I1

United Kingdom

(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.

Annotations

Textual amendments

F1: Words 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)
F2: Words 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)
F3: Words 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

I1: Reg. 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