Regulation 148 Amendment of regulation 188 (reporting obligations on holders)

(1)

Regulation 188 is amended as follows.

(2)

In each place where it occurs, for “Eudravigilance database” substitute “licensing authority”.

(3)

In paragraph (1)—

(a)

in sub-paragraph (a)—

(i)

for “EEA” substitute “United Kingdom”, and

(ii)

for “third countries” substitute “countries other than the United Kingdom”;

(b)

in sub-paragraph (b), for “EEA” substitute “United Kingdom”;

(c)

in sub-paragraph (e), for “EMA and the competent authorities of the EEA States” substitute “licensing authority”.

(4)

Omit paragraphs (2) and (3).

(5)

In paragraph (4)(a), omit “other than monitored publications”.

(6)

In paragraph (5), omit the definitions of “monitored active substance” and “monitored publication”.

(7)

Omit paragraph (6).