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