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7.—(1) Chapter 5 is amended as follows.
(2) In Article 59—
(a)in paragraph 1—
(i)in the second subparagraph, in the words before point (a)—
(aa)omit “, adjuvants”;
(bb)for “Member State” substitute “competent authority”;
(ii)in the third subparagraph—
(aa)for “the Member State which received it” substitute “any competent authority”;
(bb)omit “and adjuvants”;
(iii)in the fourth subparagraph, for “first authorisation in that Member State” substitute “the first authorisation by a competent authority in the United Kingdom in relation to which the report is submitted”;
(iv)in the fifth subparagraph, for “in that Member State” substitute “described in the fourth subparagraph”;
(b)in paragraph 3—
(i)omit “, adjuvant”;
(ii)for “Member State” substitute “competent authority”.
(3) In Article 60—
(a)in paragraph 1—
(i)for “and adjuvant, rapporteur Member States” substitute “, the assessing competent authority”;
(ii)for “Member States and the Commission” substitute “other competent authorities”;
(b)in paragraph 2—
(i)in the words before point (a), for “Member States” substitute “a competent authority”;
(ii)in point (a), omit “, adjuvant”;
(c)after paragraph 3 insert—
“4. In paragraph 1, “assessing competent authority” has the same meaning as in Subsection 2 of Section 1 of Chapter 2.”.
(4) In Article 61—
(a)in paragraph 1, in the first subparagraph—
(i)in the first sentence, omit “or for an adjuvant”;
(ii)in the second sentence, for “The competent authority” substitute “A competent authority”;
(b)in paragraph 2, for “The competent authority of the Member State” substitute “A competent authority”.
(5) In Article 62—
(a)in paragraph 2—
(i)for “Member States” substitute “A competent authority”;
(ii)for “Annex II to Directive 1999/45/EC” substitute “Part 3 of Annex 1 to Regulation (EC) No 1272/2008 of the European Parliament and of the Council”;
(b)in paragraph 4—
(i)in the first subparagraph—
(aa)omit “, or of adjuvants”;
(bb)omit “of the Member State”;
(ii)in the second subparagraph, omit “of that Member State”;
(c)in paragraph 6—
(i)in the second sentence—
(aa)omit “of the Member State”;
(bb)omit “administered under national law”;
(ii)in the third sentence, omit “of the Member States”;
(iii)in the fourth sentence, for “in the courts of the Member States” substitute “as a civil debt”.
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