PART 11Amendment of Part 11 (Pharmacovigilance)
Amendment of regulation 198 (post-authorisation safety studies: general provisions)I1158
1
Regulation 198 is amended as follows.
2
In paragraph (2),
F2a
“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),
F1i
“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),
F3i
“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.