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PART 8Amendments to Schedule 6 to the 2013 Regulations

Amendment to paragraph 9

159.  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”.