Regulation 159 Amendment to paragraph 9

In paragraph 9 (adverse reactions)—

(a)

for “manufacturer, importer or retailer” substitute “manufacturer or importer”;

(b)

in paragraph (a) for “adverse reactions (as defined in paragraph 57 of Schedule 1)” substitute “adverse events”;

(c)

in paragraph (b) for “adverse reaction”, in both places it occurs, substitute “adverse event”;

(d)

omit sub-paragraph (2);

(e)

in the heading for “Adverse reactions” substitute “Adverse events”.