Regulation 149 Amendment of regulation 189 (signal detection: licensing authority obligations)
(1)
Regulation 189 is amended as follows.
(2)
In paragraph (1)—
(a)
in sub-paragraph (a), for “in the Eudravigilance database” substitute “that it collects by virtue of operating its pharmacovigilance system under this Part”; and
(b)
in sub-paragraph (d), for “regulations 59 to 61” substitute “regulations 59, 60 and 61”.
(3)
Omit paragraphs (2) to (4).