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24.—(1) Schedule 3 is amended as follows.
(2) In Part 1(1), in paragraph 3(b), after “summary of product characteristics” insert “, or equivalent document,”.
(3) In Part 2—
(a)in paragraph 1(b), for “an EEA State”(2), substitute “the United Kingdom or a country that is included in the list referred to in regulation 3(11A)”;
(b)in paragraph 4, for “another”, substitute “an”;
(c)in paragraph 7—
(i)before “authorisation”, insert “manufacturing”;
(ii)omit “referred to in Article 13 of the Directive”;
(d)in paragraph 8—
(i)in sub-paragraph (1), for “Article 13(3) of the Directive” substitute “regulation 43(2)”;
(ii)in sub-paragraph (2)—
(aa)omit “from a third country”;
(bb)before “authorisation” insert “manufacturing”;
(cc)omit “referred to in Article 13 of the Directive”;
(dd)in paragraph (a), for “European Economic Area”, substitute “United Kingdom”;
(iii)in paragraph 11(4)(a), after “summary of product characteristics” insert “or equivalent document”.
(4) In Part 3, in paragraph 1(b), for “an EEA State”, substitute “the United Kingdom or a country that is included in the list referred to in regulation 3(11A)”.
(5) In Part 4, in paragraph 1(b), for “an EEA State”, substitute “the United Kingdom or a country that is included in the list referred to in regulation 3(11A)”.
Part 1 was amended by S.I. 2008/941.
The words “an EEA State” were substituted by S.I. 2006/1928.
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